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Acid series: Azelaic acid
However, it has many positive qualities, including being gentle enough to use daily and is safe to use in pregnancy. It is antibacterial, comedolytic, keratolytic, and has antioxidant activity. Unfortunately, in the last decade the formulations of azelaic acid have not been changed considerably. The 20% cream, 15% gel, and 15% foam vehicles are often too irritating and drying to be used in the population it is intended for: those with rosacea, or with inflamed or sensitive skin.
Azelaic acid is a dicarboxylic acid produced by Pityrosporum ovale. It inhibits the synthesis of cellular proteins and is bactericidal against Propionibacterium acnes and Staphylococcus epidermidis. Azelaic acid is both keratolytic and comedolytic by decreasing keratohyalin granules and reducing filaggrin in the epidermis. It not only scavenges free oxygen radicals, thereby reducing inflammation, but is also a tyrosinase inhibitor – making it a safe, non–hydroquinone-based alternative to skin lightening.
Azelaic acid has little toxicity, it is ingested regularly as it is found in wheat, barley, and rye. Topical side effects are usually mild and can subside with increased use. The most common side effects include erythema, local stinging, pruritus, scaling, and a burning sensation. It is considered safe in pregnancy and a great alternative to medications for acne in pregnant or nursing patients.
The largest constraint with azelaic acid preparations on the market – and most likely the reason it has not been more widely used for acne, rosacea, antiaging, and hyperpigmentation – is the formulation. The foam and gel preparations are irritating and difficult to use on dry or sensitive skin. The 20% cream preparations are slightly better tolerated; however, in vitro skin-penetration studies have shown that cutaneous penetration of azelaic acid is greater after application of a 15% gel (aqueous-based vehicle) and 15% foam (hydrophilic oil-in-water emulsion) as compared with the 20% cream formulations.
In my clinical experience, azelaic acid can only be used in rosacea patients with oily or nonsensitive skin. The majority of my rosacea patients cannot tolerate the burning sensation, albeit transient and mild. Acne patients who do not have dry skin and pregnant patients with mild acne are a great population for integrating azelaic acid into an acne regimen. I also use azelaic acid as an alternative for mild melasma and lentigines in patients who are tapering off hydroquinone or cannot use hydroquinone. In the future, we need better, creamier, nonirritating formulations to be developed and more studies of higher concentrations of this acid for both prescription/patient at-home use, as well as more elegant in-office localized peel systems using azelaic acid.
Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
References
Fitton A and Goa KL. Drugs. 1991 May;41(5):780-98.
Del Rosso JQ. J Clin Aesthet Dermatol. 2017 Mar;10(3):37-40.
Breathnach AC et al. Clin Dermatol. Apr-Jun 1989;7(2):106-19.
However, it has many positive qualities, including being gentle enough to use daily and is safe to use in pregnancy. It is antibacterial, comedolytic, keratolytic, and has antioxidant activity. Unfortunately, in the last decade the formulations of azelaic acid have not been changed considerably. The 20% cream, 15% gel, and 15% foam vehicles are often too irritating and drying to be used in the population it is intended for: those with rosacea, or with inflamed or sensitive skin.
Azelaic acid is a dicarboxylic acid produced by Pityrosporum ovale. It inhibits the synthesis of cellular proteins and is bactericidal against Propionibacterium acnes and Staphylococcus epidermidis. Azelaic acid is both keratolytic and comedolytic by decreasing keratohyalin granules and reducing filaggrin in the epidermis. It not only scavenges free oxygen radicals, thereby reducing inflammation, but is also a tyrosinase inhibitor – making it a safe, non–hydroquinone-based alternative to skin lightening.
Azelaic acid has little toxicity, it is ingested regularly as it is found in wheat, barley, and rye. Topical side effects are usually mild and can subside with increased use. The most common side effects include erythema, local stinging, pruritus, scaling, and a burning sensation. It is considered safe in pregnancy and a great alternative to medications for acne in pregnant or nursing patients.
The largest constraint with azelaic acid preparations on the market – and most likely the reason it has not been more widely used for acne, rosacea, antiaging, and hyperpigmentation – is the formulation. The foam and gel preparations are irritating and difficult to use on dry or sensitive skin. The 20% cream preparations are slightly better tolerated; however, in vitro skin-penetration studies have shown that cutaneous penetration of azelaic acid is greater after application of a 15% gel (aqueous-based vehicle) and 15% foam (hydrophilic oil-in-water emulsion) as compared with the 20% cream formulations.
In my clinical experience, azelaic acid can only be used in rosacea patients with oily or nonsensitive skin. The majority of my rosacea patients cannot tolerate the burning sensation, albeit transient and mild. Acne patients who do not have dry skin and pregnant patients with mild acne are a great population for integrating azelaic acid into an acne regimen. I also use azelaic acid as an alternative for mild melasma and lentigines in patients who are tapering off hydroquinone or cannot use hydroquinone. In the future, we need better, creamier, nonirritating formulations to be developed and more studies of higher concentrations of this acid for both prescription/patient at-home use, as well as more elegant in-office localized peel systems using azelaic acid.
Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
References
Fitton A and Goa KL. Drugs. 1991 May;41(5):780-98.
Del Rosso JQ. J Clin Aesthet Dermatol. 2017 Mar;10(3):37-40.
Breathnach AC et al. Clin Dermatol. Apr-Jun 1989;7(2):106-19.
However, it has many positive qualities, including being gentle enough to use daily and is safe to use in pregnancy. It is antibacterial, comedolytic, keratolytic, and has antioxidant activity. Unfortunately, in the last decade the formulations of azelaic acid have not been changed considerably. The 20% cream, 15% gel, and 15% foam vehicles are often too irritating and drying to be used in the population it is intended for: those with rosacea, or with inflamed or sensitive skin.
Azelaic acid is a dicarboxylic acid produced by Pityrosporum ovale. It inhibits the synthesis of cellular proteins and is bactericidal against Propionibacterium acnes and Staphylococcus epidermidis. Azelaic acid is both keratolytic and comedolytic by decreasing keratohyalin granules and reducing filaggrin in the epidermis. It not only scavenges free oxygen radicals, thereby reducing inflammation, but is also a tyrosinase inhibitor – making it a safe, non–hydroquinone-based alternative to skin lightening.
Azelaic acid has little toxicity, it is ingested regularly as it is found in wheat, barley, and rye. Topical side effects are usually mild and can subside with increased use. The most common side effects include erythema, local stinging, pruritus, scaling, and a burning sensation. It is considered safe in pregnancy and a great alternative to medications for acne in pregnant or nursing patients.
The largest constraint with azelaic acid preparations on the market – and most likely the reason it has not been more widely used for acne, rosacea, antiaging, and hyperpigmentation – is the formulation. The foam and gel preparations are irritating and difficult to use on dry or sensitive skin. The 20% cream preparations are slightly better tolerated; however, in vitro skin-penetration studies have shown that cutaneous penetration of azelaic acid is greater after application of a 15% gel (aqueous-based vehicle) and 15% foam (hydrophilic oil-in-water emulsion) as compared with the 20% cream formulations.
In my clinical experience, azelaic acid can only be used in rosacea patients with oily or nonsensitive skin. The majority of my rosacea patients cannot tolerate the burning sensation, albeit transient and mild. Acne patients who do not have dry skin and pregnant patients with mild acne are a great population for integrating azelaic acid into an acne regimen. I also use azelaic acid as an alternative for mild melasma and lentigines in patients who are tapering off hydroquinone or cannot use hydroquinone. In the future, we need better, creamier, nonirritating formulations to be developed and more studies of higher concentrations of this acid for both prescription/patient at-home use, as well as more elegant in-office localized peel systems using azelaic acid.
Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
References
Fitton A and Goa KL. Drugs. 1991 May;41(5):780-98.
Del Rosso JQ. J Clin Aesthet Dermatol. 2017 Mar;10(3):37-40.
Breathnach AC et al. Clin Dermatol. Apr-Jun 1989;7(2):106-19.
Moisturizers and skin barrier repair
There are dozens of skin care products that claim to repair the barrier that do not have the science or ingredient content to back them up.
Does a skin barrier repair moisturizer really repair?
First, let’s briefly review what the skin barrier is. The stratum corneum (SC), the most superficial layer of the epidermis, averages approximately 15-cell layers in thickness.1,2 The keratinocytes reside there in a pattern resembling a brick wall. The “mortar” is composed of the lipid contents extruded from the lamellar granules. This protective barrier functions to prevent transepidermal water loss (TEWL) and entry of allergens, irritants, and pathogens into deeper layers of the skin. This column will focus briefly on the structure and function of the skin barrier and the barrier repair technologies that use synthetic lipids such as myristoyl-palmitoyl and myristyl/palmityl-oxo-stearamide/arachamide MEA.
Structure of the skin barrier
SC keratinocytes are surrounded by lamella made from lipid bilayers. The lipids have hydrophilic heads and hydrophobic tails; the bilayer arises when the hydrophobic tails face the center and the hydrophilic heads face out of the bilayer. This formation yields a disc-shaped hydrophobic lamellar center. There are actually several of these lamellar layers between keratinocytes.
The naturally occurring primary lipids of the bilayer lamellae are made up of an equal ratio of ceramides, cholesterol, and free fatty acid. Arranged in a 1:1:1 ratio, they fit together like pieces of a puzzle to achieve skin barrier homeostasis. The shape and size of these puzzle pieces is critical. An incorrect shape results in a hole in the skin barrier resulting in dehydration, inflammation, and sensitivity.
Ceramides
Ceramides are a complex family of lipids (sphingolipids – a sphingoid base and a fatty acid) involved in cell, as well as barrier, homeostasis and water-holding capacity. In fact, they are known to play a crucial role in cell proliferation, differentiation, and apoptosis.3 There are at least 16 types of naturally occurring ceramides. For years, they have been included in barrier repair moisturizers. They are difficult to work with in moisturizers for several reasons:
- Ceramides are abundant in brain tissue and the ceramides used in moisturizers in the past were derived from bovine brain tissue. Prior to the emergence of bovine spongiform encephalopathy (mad cow disease), many ceramides in skin-care products were animal derived, which made them expensive and undesirable.
- Ceramides in skin care that are made from plant sources are referred to as phyto-derived ceramides. Although they share a similar structure with ceramides that occur in human skin, there are differences in chain length, hydroxylation pattern, and the degree of unsaturation that lead to structural diversity.4 The shape of ceramides is critical for a strong skin barrier because the lipids in the skin barrier must fit together like puzzle pieces to form a water-tight barrier. Natural sources of ceramides include rice, wheat, potato, konjac, and maize. Standardization of ceramide shape and structure makes using phyto-derived ceramides in skin care products challenging.
- Ceramides, because of their waxy consistency, require heat during the mixing process of skin care product manufacturing. This heat can make other ingredients inactive in the skin care formulation. (Ceramides are typically added early in the formulation process, and the heat-sensitive ones are added later.)
- Many forms of ceramides are unstable in the product manufacturing and bottling processes.
- Skin penetration of ceramides depends on the shape and size of ceramides.
Synthetic ceramides have been developed to make ceramides safe, affordable, and more easily formulated into moisturizers. These formulations synthesized in the lab are sometimes called pseudoceramides because they are structurally different compounds that mimic the activity of ceramides. They are developed to be less expensive to manufacture, safer than those derived from animals, and easier to formulate, and they can be made into the specific shape of the ceramide puzzle piece.
Ceramides in skin care
The naturally occurring intercellular lipids of the SC are composed of approximately equal proportions of ceramides, cholesterol, and fatty acids (referred to in this article as the “three barrier lipids” for simplicity).5-9 Alterations in any of these three barrier lipids or their regulatory enzymes result in impairments in the function of the epidermal barrier. Therefore, any synthetic ceramide must mimic the shape of natural ceramides, or the three barrier lipids in the moisturizer must mimic the shape of the entire bilayer lamella. Unfortunately, most barrier repair moisturizers do not meet these criteria and are not true barrier repair moisturizers.
How do you know if a moisturizer repairs the skin barrier?
Clinical tests such as measuring transepidermal water loss (TEWL) with a Tewameter are usually done to support the barrier repair claim. However, occlusive ingredients like oils can lower TEWL without affecting the barrier. In fact, we believe that sebum on the skin can make an impaired barrier and result in normal TEWL even when the barrier is impaired. So, just because a product improved TEWL does not necessarily mean that it repairs the barrier.
One way to test the ability of a moisturizer to repair the barrier is to look at a structural analysis of the moisturizer to see if it forms the requisite bilayer lamellar shape. An easy way to do this testing is to look for the cross pattern under a cross polarized microscope. The cross pattern is known as optical anisotropy. 8
The best barrier repair creams
Optimal barrier repair creams either feature a 1:1:1 ratio of epidermal lipids or form a cross structure when viewed with a cross-polarized microscope.8 There are several categories of barrier repair moisturizers that meet these criteria.
Barrier repair creams with a 1:1:1 ratio of lipids:
Peter Elias, MD, holds the patent on barrier repair moisturizer technology that has a 1:1:1 ratio. His well-established technology is used in a prescription barrier repair cream called EpiCeram® which is approved by the Food and Drug Administration to treat eczema. There are no other moisturizers that I know of that contain this 1:1:1 lipid ratio.
There is a barrier repair cream on the market that contains a 2:4:2 ratio of lipids based on a study that showed that this ratio is effective in older skin with an impaired barrier. It is unknown if this moisturizer forms a cross pattern.
Barrier repair creams that demonstrate a cross pattern:
Multilamellar emulsion (MLE) technology: This barrier repair technology, invented in South Korea, contains the synthetic pseudoceramide called myristyl/palmityl-oxo-stearamide/arachamide MEA (C34H67NO3/C36H71NO3/C38H75NO3), or the pseudoceramide myristoyl-palmitoyl-oxostearamide-arachamide MEA.
In a 2019 pilot study by Ye and colleagues, the investigators treated 33 older volunteers twice daily for 30 days with approximately 3 mL of an emollient containing MLE technology. In addition, 30 untreated older subjects and 11 young volunteers served as controls. The investigators found that the topically applied barrier repair emollient significantly improved barrier function, as well as stratum corneum hydration. Circulating levels of the important, age-related plasma cytokines interleukin-1 beta and IL-6 were found to have normalized, while tumor necrosis factor–alpha decreased markedly. The investigators suggested that repair of the skin barrier might diminish circulating proinflammatory cytokine levels (such as amyloid A) in aged humans, potentially mitigating the development of chronic inflammatory conditions.10
MLE technology has also been shown to improve childhood atopic dermatitis and prevent steroid atrophy.11,12 The consistent use of MLE technology in moisturizers has been shown to alleviate inflammatory factors in the blood and is believed to lessen systemic inflammation.10
Physiologic (PSL) lipid repair technology: This technology was invented by one of the South Korean researchers who helped develop MLE technology. It contains pseudoceramides, fatty acids, and cholesterol. The figure of the cross pattern above, as seen under the cross polarized microscope, is an image taken of this PSL lipid repair technology.
Conclusion
Do not believe that a moisturizer repairs the barrier just because it says so on the label. Three of the most popular body moisturizes used to treat eczema do not actually have the proper formula to repair the barrier. Unfortunately, there are dozens of skin care products that claim to repair the barrier that do not have the science or ingredient content to back them up. To restore the skin barrier to a healthy condition, it is imperative that the barrier repair moisturizers that you are recommending for patients have the correct 1:1:1 ratio of epidermal lipids or contain bilayer lamella that mimic the natural multilamellar layers and display the cross pattern under a cross-polarized microscope.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Christophers E and Kligman AM. J Invest Dermatol. 1964;42:407-9.
2. Blair C. Br J Dermatol. 1968;80(7):430-6.
3. Morita O et al. Food Chem Toxicol. 2009 Apr;47(4):681-6.
4. Tessema E N et al. Skin pharmacology and physiology. 2017;30(3):115-38.
5. Coderch L et al. Am J Clin Dermatol. 2003;4(2):107-29.
6. Man MQ et al. Arch Dermatol. 1993;129(6):728-38.
7. Man MQ M et al. J Invest Dermatol. 1996 May;106(5):1096-101.
8. Park BD et al. J Invest Dermatol. 2003;121(4):794-801.
9. Proksch E and Jensen J. Skin as an organ of protection, in “Fitzpatrick’s Dermatology in General Medicine,” 7th ed. New York: McGraw-Hill, 2008, pp. 383-95.
10. Ye L et al. J Eur Acad Dermatol Venereol. 2019;33(11):2197-201.
11. Lee EJ et al. Ann Dermatol. 2003;15(4):133-8.
12. Ahn SK et al. J Dermatol. 2006;33(2):80-90.
There are dozens of skin care products that claim to repair the barrier that do not have the science or ingredient content to back them up.
Does a skin barrier repair moisturizer really repair?
First, let’s briefly review what the skin barrier is. The stratum corneum (SC), the most superficial layer of the epidermis, averages approximately 15-cell layers in thickness.1,2 The keratinocytes reside there in a pattern resembling a brick wall. The “mortar” is composed of the lipid contents extruded from the lamellar granules. This protective barrier functions to prevent transepidermal water loss (TEWL) and entry of allergens, irritants, and pathogens into deeper layers of the skin. This column will focus briefly on the structure and function of the skin barrier and the barrier repair technologies that use synthetic lipids such as myristoyl-palmitoyl and myristyl/palmityl-oxo-stearamide/arachamide MEA.
Structure of the skin barrier
SC keratinocytes are surrounded by lamella made from lipid bilayers. The lipids have hydrophilic heads and hydrophobic tails; the bilayer arises when the hydrophobic tails face the center and the hydrophilic heads face out of the bilayer. This formation yields a disc-shaped hydrophobic lamellar center. There are actually several of these lamellar layers between keratinocytes.
The naturally occurring primary lipids of the bilayer lamellae are made up of an equal ratio of ceramides, cholesterol, and free fatty acid. Arranged in a 1:1:1 ratio, they fit together like pieces of a puzzle to achieve skin barrier homeostasis. The shape and size of these puzzle pieces is critical. An incorrect shape results in a hole in the skin barrier resulting in dehydration, inflammation, and sensitivity.
Ceramides
Ceramides are a complex family of lipids (sphingolipids – a sphingoid base and a fatty acid) involved in cell, as well as barrier, homeostasis and water-holding capacity. In fact, they are known to play a crucial role in cell proliferation, differentiation, and apoptosis.3 There are at least 16 types of naturally occurring ceramides. For years, they have been included in barrier repair moisturizers. They are difficult to work with in moisturizers for several reasons:
- Ceramides are abundant in brain tissue and the ceramides used in moisturizers in the past were derived from bovine brain tissue. Prior to the emergence of bovine spongiform encephalopathy (mad cow disease), many ceramides in skin-care products were animal derived, which made them expensive and undesirable.
- Ceramides in skin care that are made from plant sources are referred to as phyto-derived ceramides. Although they share a similar structure with ceramides that occur in human skin, there are differences in chain length, hydroxylation pattern, and the degree of unsaturation that lead to structural diversity.4 The shape of ceramides is critical for a strong skin barrier because the lipids in the skin barrier must fit together like puzzle pieces to form a water-tight barrier. Natural sources of ceramides include rice, wheat, potato, konjac, and maize. Standardization of ceramide shape and structure makes using phyto-derived ceramides in skin care products challenging.
- Ceramides, because of their waxy consistency, require heat during the mixing process of skin care product manufacturing. This heat can make other ingredients inactive in the skin care formulation. (Ceramides are typically added early in the formulation process, and the heat-sensitive ones are added later.)
- Many forms of ceramides are unstable in the product manufacturing and bottling processes.
- Skin penetration of ceramides depends on the shape and size of ceramides.
Synthetic ceramides have been developed to make ceramides safe, affordable, and more easily formulated into moisturizers. These formulations synthesized in the lab are sometimes called pseudoceramides because they are structurally different compounds that mimic the activity of ceramides. They are developed to be less expensive to manufacture, safer than those derived from animals, and easier to formulate, and they can be made into the specific shape of the ceramide puzzle piece.
Ceramides in skin care
The naturally occurring intercellular lipids of the SC are composed of approximately equal proportions of ceramides, cholesterol, and fatty acids (referred to in this article as the “three barrier lipids” for simplicity).5-9 Alterations in any of these three barrier lipids or their regulatory enzymes result in impairments in the function of the epidermal barrier. Therefore, any synthetic ceramide must mimic the shape of natural ceramides, or the three barrier lipids in the moisturizer must mimic the shape of the entire bilayer lamella. Unfortunately, most barrier repair moisturizers do not meet these criteria and are not true barrier repair moisturizers.
How do you know if a moisturizer repairs the skin barrier?
Clinical tests such as measuring transepidermal water loss (TEWL) with a Tewameter are usually done to support the barrier repair claim. However, occlusive ingredients like oils can lower TEWL without affecting the barrier. In fact, we believe that sebum on the skin can make an impaired barrier and result in normal TEWL even when the barrier is impaired. So, just because a product improved TEWL does not necessarily mean that it repairs the barrier.
One way to test the ability of a moisturizer to repair the barrier is to look at a structural analysis of the moisturizer to see if it forms the requisite bilayer lamellar shape. An easy way to do this testing is to look for the cross pattern under a cross polarized microscope. The cross pattern is known as optical anisotropy. 8
The best barrier repair creams
Optimal barrier repair creams either feature a 1:1:1 ratio of epidermal lipids or form a cross structure when viewed with a cross-polarized microscope.8 There are several categories of barrier repair moisturizers that meet these criteria.
Barrier repair creams with a 1:1:1 ratio of lipids:
Peter Elias, MD, holds the patent on barrier repair moisturizer technology that has a 1:1:1 ratio. His well-established technology is used in a prescription barrier repair cream called EpiCeram® which is approved by the Food and Drug Administration to treat eczema. There are no other moisturizers that I know of that contain this 1:1:1 lipid ratio.
There is a barrier repair cream on the market that contains a 2:4:2 ratio of lipids based on a study that showed that this ratio is effective in older skin with an impaired barrier. It is unknown if this moisturizer forms a cross pattern.
Barrier repair creams that demonstrate a cross pattern:
Multilamellar emulsion (MLE) technology: This barrier repair technology, invented in South Korea, contains the synthetic pseudoceramide called myristyl/palmityl-oxo-stearamide/arachamide MEA (C34H67NO3/C36H71NO3/C38H75NO3), or the pseudoceramide myristoyl-palmitoyl-oxostearamide-arachamide MEA.
In a 2019 pilot study by Ye and colleagues, the investigators treated 33 older volunteers twice daily for 30 days with approximately 3 mL of an emollient containing MLE technology. In addition, 30 untreated older subjects and 11 young volunteers served as controls. The investigators found that the topically applied barrier repair emollient significantly improved barrier function, as well as stratum corneum hydration. Circulating levels of the important, age-related plasma cytokines interleukin-1 beta and IL-6 were found to have normalized, while tumor necrosis factor–alpha decreased markedly. The investigators suggested that repair of the skin barrier might diminish circulating proinflammatory cytokine levels (such as amyloid A) in aged humans, potentially mitigating the development of chronic inflammatory conditions.10
MLE technology has also been shown to improve childhood atopic dermatitis and prevent steroid atrophy.11,12 The consistent use of MLE technology in moisturizers has been shown to alleviate inflammatory factors in the blood and is believed to lessen systemic inflammation.10
Physiologic (PSL) lipid repair technology: This technology was invented by one of the South Korean researchers who helped develop MLE technology. It contains pseudoceramides, fatty acids, and cholesterol. The figure of the cross pattern above, as seen under the cross polarized microscope, is an image taken of this PSL lipid repair technology.
Conclusion
Do not believe that a moisturizer repairs the barrier just because it says so on the label. Three of the most popular body moisturizes used to treat eczema do not actually have the proper formula to repair the barrier. Unfortunately, there are dozens of skin care products that claim to repair the barrier that do not have the science or ingredient content to back them up. To restore the skin barrier to a healthy condition, it is imperative that the barrier repair moisturizers that you are recommending for patients have the correct 1:1:1 ratio of epidermal lipids or contain bilayer lamella that mimic the natural multilamellar layers and display the cross pattern under a cross-polarized microscope.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Christophers E and Kligman AM. J Invest Dermatol. 1964;42:407-9.
2. Blair C. Br J Dermatol. 1968;80(7):430-6.
3. Morita O et al. Food Chem Toxicol. 2009 Apr;47(4):681-6.
4. Tessema E N et al. Skin pharmacology and physiology. 2017;30(3):115-38.
5. Coderch L et al. Am J Clin Dermatol. 2003;4(2):107-29.
6. Man MQ et al. Arch Dermatol. 1993;129(6):728-38.
7. Man MQ M et al. J Invest Dermatol. 1996 May;106(5):1096-101.
8. Park BD et al. J Invest Dermatol. 2003;121(4):794-801.
9. Proksch E and Jensen J. Skin as an organ of protection, in “Fitzpatrick’s Dermatology in General Medicine,” 7th ed. New York: McGraw-Hill, 2008, pp. 383-95.
10. Ye L et al. J Eur Acad Dermatol Venereol. 2019;33(11):2197-201.
11. Lee EJ et al. Ann Dermatol. 2003;15(4):133-8.
12. Ahn SK et al. J Dermatol. 2006;33(2):80-90.
There are dozens of skin care products that claim to repair the barrier that do not have the science or ingredient content to back them up.
Does a skin barrier repair moisturizer really repair?
First, let’s briefly review what the skin barrier is. The stratum corneum (SC), the most superficial layer of the epidermis, averages approximately 15-cell layers in thickness.1,2 The keratinocytes reside there in a pattern resembling a brick wall. The “mortar” is composed of the lipid contents extruded from the lamellar granules. This protective barrier functions to prevent transepidermal water loss (TEWL) and entry of allergens, irritants, and pathogens into deeper layers of the skin. This column will focus briefly on the structure and function of the skin barrier and the barrier repair technologies that use synthetic lipids such as myristoyl-palmitoyl and myristyl/palmityl-oxo-stearamide/arachamide MEA.
Structure of the skin barrier
SC keratinocytes are surrounded by lamella made from lipid bilayers. The lipids have hydrophilic heads and hydrophobic tails; the bilayer arises when the hydrophobic tails face the center and the hydrophilic heads face out of the bilayer. This formation yields a disc-shaped hydrophobic lamellar center. There are actually several of these lamellar layers between keratinocytes.
The naturally occurring primary lipids of the bilayer lamellae are made up of an equal ratio of ceramides, cholesterol, and free fatty acid. Arranged in a 1:1:1 ratio, they fit together like pieces of a puzzle to achieve skin barrier homeostasis. The shape and size of these puzzle pieces is critical. An incorrect shape results in a hole in the skin barrier resulting in dehydration, inflammation, and sensitivity.
Ceramides
Ceramides are a complex family of lipids (sphingolipids – a sphingoid base and a fatty acid) involved in cell, as well as barrier, homeostasis and water-holding capacity. In fact, they are known to play a crucial role in cell proliferation, differentiation, and apoptosis.3 There are at least 16 types of naturally occurring ceramides. For years, they have been included in barrier repair moisturizers. They are difficult to work with in moisturizers for several reasons:
- Ceramides are abundant in brain tissue and the ceramides used in moisturizers in the past were derived from bovine brain tissue. Prior to the emergence of bovine spongiform encephalopathy (mad cow disease), many ceramides in skin-care products were animal derived, which made them expensive and undesirable.
- Ceramides in skin care that are made from plant sources are referred to as phyto-derived ceramides. Although they share a similar structure with ceramides that occur in human skin, there are differences in chain length, hydroxylation pattern, and the degree of unsaturation that lead to structural diversity.4 The shape of ceramides is critical for a strong skin barrier because the lipids in the skin barrier must fit together like puzzle pieces to form a water-tight barrier. Natural sources of ceramides include rice, wheat, potato, konjac, and maize. Standardization of ceramide shape and structure makes using phyto-derived ceramides in skin care products challenging.
- Ceramides, because of their waxy consistency, require heat during the mixing process of skin care product manufacturing. This heat can make other ingredients inactive in the skin care formulation. (Ceramides are typically added early in the formulation process, and the heat-sensitive ones are added later.)
- Many forms of ceramides are unstable in the product manufacturing and bottling processes.
- Skin penetration of ceramides depends on the shape and size of ceramides.
Synthetic ceramides have been developed to make ceramides safe, affordable, and more easily formulated into moisturizers. These formulations synthesized in the lab are sometimes called pseudoceramides because they are structurally different compounds that mimic the activity of ceramides. They are developed to be less expensive to manufacture, safer than those derived from animals, and easier to formulate, and they can be made into the specific shape of the ceramide puzzle piece.
Ceramides in skin care
The naturally occurring intercellular lipids of the SC are composed of approximately equal proportions of ceramides, cholesterol, and fatty acids (referred to in this article as the “three barrier lipids” for simplicity).5-9 Alterations in any of these three barrier lipids or their regulatory enzymes result in impairments in the function of the epidermal barrier. Therefore, any synthetic ceramide must mimic the shape of natural ceramides, or the three barrier lipids in the moisturizer must mimic the shape of the entire bilayer lamella. Unfortunately, most barrier repair moisturizers do not meet these criteria and are not true barrier repair moisturizers.
How do you know if a moisturizer repairs the skin barrier?
Clinical tests such as measuring transepidermal water loss (TEWL) with a Tewameter are usually done to support the barrier repair claim. However, occlusive ingredients like oils can lower TEWL without affecting the barrier. In fact, we believe that sebum on the skin can make an impaired barrier and result in normal TEWL even when the barrier is impaired. So, just because a product improved TEWL does not necessarily mean that it repairs the barrier.
One way to test the ability of a moisturizer to repair the barrier is to look at a structural analysis of the moisturizer to see if it forms the requisite bilayer lamellar shape. An easy way to do this testing is to look for the cross pattern under a cross polarized microscope. The cross pattern is known as optical anisotropy. 8
The best barrier repair creams
Optimal barrier repair creams either feature a 1:1:1 ratio of epidermal lipids or form a cross structure when viewed with a cross-polarized microscope.8 There are several categories of barrier repair moisturizers that meet these criteria.
Barrier repair creams with a 1:1:1 ratio of lipids:
Peter Elias, MD, holds the patent on barrier repair moisturizer technology that has a 1:1:1 ratio. His well-established technology is used in a prescription barrier repair cream called EpiCeram® which is approved by the Food and Drug Administration to treat eczema. There are no other moisturizers that I know of that contain this 1:1:1 lipid ratio.
There is a barrier repair cream on the market that contains a 2:4:2 ratio of lipids based on a study that showed that this ratio is effective in older skin with an impaired barrier. It is unknown if this moisturizer forms a cross pattern.
Barrier repair creams that demonstrate a cross pattern:
Multilamellar emulsion (MLE) technology: This barrier repair technology, invented in South Korea, contains the synthetic pseudoceramide called myristyl/palmityl-oxo-stearamide/arachamide MEA (C34H67NO3/C36H71NO3/C38H75NO3), or the pseudoceramide myristoyl-palmitoyl-oxostearamide-arachamide MEA.
In a 2019 pilot study by Ye and colleagues, the investigators treated 33 older volunteers twice daily for 30 days with approximately 3 mL of an emollient containing MLE technology. In addition, 30 untreated older subjects and 11 young volunteers served as controls. The investigators found that the topically applied barrier repair emollient significantly improved barrier function, as well as stratum corneum hydration. Circulating levels of the important, age-related plasma cytokines interleukin-1 beta and IL-6 were found to have normalized, while tumor necrosis factor–alpha decreased markedly. The investigators suggested that repair of the skin barrier might diminish circulating proinflammatory cytokine levels (such as amyloid A) in aged humans, potentially mitigating the development of chronic inflammatory conditions.10
MLE technology has also been shown to improve childhood atopic dermatitis and prevent steroid atrophy.11,12 The consistent use of MLE technology in moisturizers has been shown to alleviate inflammatory factors in the blood and is believed to lessen systemic inflammation.10
Physiologic (PSL) lipid repair technology: This technology was invented by one of the South Korean researchers who helped develop MLE technology. It contains pseudoceramides, fatty acids, and cholesterol. The figure of the cross pattern above, as seen under the cross polarized microscope, is an image taken of this PSL lipid repair technology.
Conclusion
Do not believe that a moisturizer repairs the barrier just because it says so on the label. Three of the most popular body moisturizes used to treat eczema do not actually have the proper formula to repair the barrier. Unfortunately, there are dozens of skin care products that claim to repair the barrier that do not have the science or ingredient content to back them up. To restore the skin barrier to a healthy condition, it is imperative that the barrier repair moisturizers that you are recommending for patients have the correct 1:1:1 ratio of epidermal lipids or contain bilayer lamella that mimic the natural multilamellar layers and display the cross pattern under a cross-polarized microscope.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Christophers E and Kligman AM. J Invest Dermatol. 1964;42:407-9.
2. Blair C. Br J Dermatol. 1968;80(7):430-6.
3. Morita O et al. Food Chem Toxicol. 2009 Apr;47(4):681-6.
4. Tessema E N et al. Skin pharmacology and physiology. 2017;30(3):115-38.
5. Coderch L et al. Am J Clin Dermatol. 2003;4(2):107-29.
6. Man MQ et al. Arch Dermatol. 1993;129(6):728-38.
7. Man MQ M et al. J Invest Dermatol. 1996 May;106(5):1096-101.
8. Park BD et al. J Invest Dermatol. 2003;121(4):794-801.
9. Proksch E and Jensen J. Skin as an organ of protection, in “Fitzpatrick’s Dermatology in General Medicine,” 7th ed. New York: McGraw-Hill, 2008, pp. 383-95.
10. Ye L et al. J Eur Acad Dermatol Venereol. 2019;33(11):2197-201.
11. Lee EJ et al. Ann Dermatol. 2003;15(4):133-8.
12. Ahn SK et al. J Dermatol. 2006;33(2):80-90.
Filler complications involving vascular necrosis, vision changes on the rise
analysis showed.
“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”
Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.
In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.
When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.
Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.
“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”
Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”
Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.
“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”
The researchers reported having no financial disclosures.
Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
analysis showed.
“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”
Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.
In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.
When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.
Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.
“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”
Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”
Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.
“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”
The researchers reported having no financial disclosures.
Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
analysis showed.
“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”
Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.
In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.
When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.
Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.
“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”
Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”
Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.
“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”
The researchers reported having no financial disclosures.
Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
FROM ASDS 2021
Review finds microneedling an effective add-on to topical melasma therapies
, results from a combined systematic review and meta-analysis suggest.
“Microneedling has a similar efficacy to other drug delivery methods, such as CO2 laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”
For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.
Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.
Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”
A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO2 laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.
In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.
A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.
The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.
Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”
In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.
Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”
The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”
Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.
, results from a combined systematic review and meta-analysis suggest.
“Microneedling has a similar efficacy to other drug delivery methods, such as CO2 laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”
For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.
Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.
Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”
A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO2 laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.
In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.
A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.
The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.
Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”
In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.
Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”
The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”
Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.
, results from a combined systematic review and meta-analysis suggest.
“Microneedling has a similar efficacy to other drug delivery methods, such as CO2 laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”
For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.
Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.
Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”
A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO2 laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.
In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.
A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.
The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.
Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”
In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.
Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”
The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”
Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.
FROM ASDS 2021
International panel backs energy-based devices as first-line treatment of acne scars
International consensus .
Peter R. Shumaker, MD, a dermatologist and dermatologic surgeon at the VA San Diego Healthcare System and one of the authors of the paper, noted that a panel of 24 international experts in dermatology and plastic surgery assembled to develop the recommendations for integrating EBDs into the management of acne scarring.
“The advent of fractional laser technology in the mid-2000s ushered in an exciting new period of exploration and advances in scar treatment with EBDs,” Dr. Shumaker said in an interview. “Despite intense interest and a wealth of available literature, international treatment guidelines and patient access to these potentially life-changing treatments are currently lagging behind our capabilities.”
One of the key recommendations of the paper is that EBDs should have an expanded role in the treatment of acne scars, according to Dr. Shumaker, associate clinical professor of dermatology at the University of California, San Diego. “Panel members were unanimous in their view that EBDs, particularly ablative and nonablative fractional lasers, vascular lasers, and fractional radiofrequency devices, have an important role in the management of acne scars and should be considered a first-line treatment for a variety of scar types,” he said.
The process leading to the recommendations included developing clinical questions, based on input from the panelists and a literature review, and using a two-step modified Delphi method, “an iterative process used to achieve consensus for a defined clinical problem where there is little or conflicting published evidence and where expert opinion is decisive,” the authors wrote. This involved email questionnaires highlighting different topics, including the role of EBDs in mitigating and treating acne scars in patients with active acne, the use of different EBDs for treating different types of acne scars, and considerations in treating skin of color.
The panel noted considerations in the treatment of acne scars in skin of color. “Regardless of the platform, patients with darker skin types may require treatment modifications including: a reduction in fluence/pulse energy; decreased microcolumn density; greater intervals between treatments; longer pulse durations; epidermal cooling with fastidious technique to ensure appropriate cooling, additional cooling in between passes to decrease bulk heating; and pretreatment and posttreatment topical regimens (e.g., retinoids, bleaching creams, etc.) and strict sun precautions,” wrote the authors.
Panelists agreed that there is an absence of large, well-controlled, multicenter comparative trials of various laser and energy treatments for acne scars. “Such trials would be helpful in establishing the relative utility and persistence of benefit of various laser treatments and also in comparing their effectiveness versus that of nonenergy treatments,” the authors noted.
Asked to comment on the paper, Andrei Metelitsa, MD, a dermatologist in Calgary, Alta., and clinical associate professor at the University of Calgary, said the consensus recommendations on EBDs in acne scarring are “providing an international expert perspective, potentially changing a long-perceived paradigm of treatments.”
Dr. Metelitsa pointed out that the authors are taking a solid position with respect to reducing the delay to initiation of laser treatment following isotretinoin therapy. “The authors take a strong stance against the old dogma of postponing laser resurfacing for at least 6 months post isotretinoin,” he said. “According to the authors, there is sufficient evidence to support the idea of safely starting laser therapies, including fractional ablative and nonablative, within 1 month post isotretinoin, much sooner than previously suggested.”
He added that the authors point to the fact most experts utilize vascular lasers, such as pulsed-dye, to treat active acne in combination with medical therapy, thus reducing duration and severity of inflammation and potentially reducing further scar formation. “According to this published consensus, such laser therapies can even be used while the patient is actively treated with isotretinoin,” he said.
Dr. Metelitsa noted that the consensus recommendations outline how the choice of device should be guided by the clinical subtype of acne scars.
Dr. Shumaker, Dr. Metelitsa, and the authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
International consensus .
Peter R. Shumaker, MD, a dermatologist and dermatologic surgeon at the VA San Diego Healthcare System and one of the authors of the paper, noted that a panel of 24 international experts in dermatology and plastic surgery assembled to develop the recommendations for integrating EBDs into the management of acne scarring.
“The advent of fractional laser technology in the mid-2000s ushered in an exciting new period of exploration and advances in scar treatment with EBDs,” Dr. Shumaker said in an interview. “Despite intense interest and a wealth of available literature, international treatment guidelines and patient access to these potentially life-changing treatments are currently lagging behind our capabilities.”
One of the key recommendations of the paper is that EBDs should have an expanded role in the treatment of acne scars, according to Dr. Shumaker, associate clinical professor of dermatology at the University of California, San Diego. “Panel members were unanimous in their view that EBDs, particularly ablative and nonablative fractional lasers, vascular lasers, and fractional radiofrequency devices, have an important role in the management of acne scars and should be considered a first-line treatment for a variety of scar types,” he said.
The process leading to the recommendations included developing clinical questions, based on input from the panelists and a literature review, and using a two-step modified Delphi method, “an iterative process used to achieve consensus for a defined clinical problem where there is little or conflicting published evidence and where expert opinion is decisive,” the authors wrote. This involved email questionnaires highlighting different topics, including the role of EBDs in mitigating and treating acne scars in patients with active acne, the use of different EBDs for treating different types of acne scars, and considerations in treating skin of color.
The panel noted considerations in the treatment of acne scars in skin of color. “Regardless of the platform, patients with darker skin types may require treatment modifications including: a reduction in fluence/pulse energy; decreased microcolumn density; greater intervals between treatments; longer pulse durations; epidermal cooling with fastidious technique to ensure appropriate cooling, additional cooling in between passes to decrease bulk heating; and pretreatment and posttreatment topical regimens (e.g., retinoids, bleaching creams, etc.) and strict sun precautions,” wrote the authors.
Panelists agreed that there is an absence of large, well-controlled, multicenter comparative trials of various laser and energy treatments for acne scars. “Such trials would be helpful in establishing the relative utility and persistence of benefit of various laser treatments and also in comparing their effectiveness versus that of nonenergy treatments,” the authors noted.
Asked to comment on the paper, Andrei Metelitsa, MD, a dermatologist in Calgary, Alta., and clinical associate professor at the University of Calgary, said the consensus recommendations on EBDs in acne scarring are “providing an international expert perspective, potentially changing a long-perceived paradigm of treatments.”
Dr. Metelitsa pointed out that the authors are taking a solid position with respect to reducing the delay to initiation of laser treatment following isotretinoin therapy. “The authors take a strong stance against the old dogma of postponing laser resurfacing for at least 6 months post isotretinoin,” he said. “According to the authors, there is sufficient evidence to support the idea of safely starting laser therapies, including fractional ablative and nonablative, within 1 month post isotretinoin, much sooner than previously suggested.”
He added that the authors point to the fact most experts utilize vascular lasers, such as pulsed-dye, to treat active acne in combination with medical therapy, thus reducing duration and severity of inflammation and potentially reducing further scar formation. “According to this published consensus, such laser therapies can even be used while the patient is actively treated with isotretinoin,” he said.
Dr. Metelitsa noted that the consensus recommendations outline how the choice of device should be guided by the clinical subtype of acne scars.
Dr. Shumaker, Dr. Metelitsa, and the authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
International consensus .
Peter R. Shumaker, MD, a dermatologist and dermatologic surgeon at the VA San Diego Healthcare System and one of the authors of the paper, noted that a panel of 24 international experts in dermatology and plastic surgery assembled to develop the recommendations for integrating EBDs into the management of acne scarring.
“The advent of fractional laser technology in the mid-2000s ushered in an exciting new period of exploration and advances in scar treatment with EBDs,” Dr. Shumaker said in an interview. “Despite intense interest and a wealth of available literature, international treatment guidelines and patient access to these potentially life-changing treatments are currently lagging behind our capabilities.”
One of the key recommendations of the paper is that EBDs should have an expanded role in the treatment of acne scars, according to Dr. Shumaker, associate clinical professor of dermatology at the University of California, San Diego. “Panel members were unanimous in their view that EBDs, particularly ablative and nonablative fractional lasers, vascular lasers, and fractional radiofrequency devices, have an important role in the management of acne scars and should be considered a first-line treatment for a variety of scar types,” he said.
The process leading to the recommendations included developing clinical questions, based on input from the panelists and a literature review, and using a two-step modified Delphi method, “an iterative process used to achieve consensus for a defined clinical problem where there is little or conflicting published evidence and where expert opinion is decisive,” the authors wrote. This involved email questionnaires highlighting different topics, including the role of EBDs in mitigating and treating acne scars in patients with active acne, the use of different EBDs for treating different types of acne scars, and considerations in treating skin of color.
The panel noted considerations in the treatment of acne scars in skin of color. “Regardless of the platform, patients with darker skin types may require treatment modifications including: a reduction in fluence/pulse energy; decreased microcolumn density; greater intervals between treatments; longer pulse durations; epidermal cooling with fastidious technique to ensure appropriate cooling, additional cooling in between passes to decrease bulk heating; and pretreatment and posttreatment topical regimens (e.g., retinoids, bleaching creams, etc.) and strict sun precautions,” wrote the authors.
Panelists agreed that there is an absence of large, well-controlled, multicenter comparative trials of various laser and energy treatments for acne scars. “Such trials would be helpful in establishing the relative utility and persistence of benefit of various laser treatments and also in comparing their effectiveness versus that of nonenergy treatments,” the authors noted.
Asked to comment on the paper, Andrei Metelitsa, MD, a dermatologist in Calgary, Alta., and clinical associate professor at the University of Calgary, said the consensus recommendations on EBDs in acne scarring are “providing an international expert perspective, potentially changing a long-perceived paradigm of treatments.”
Dr. Metelitsa pointed out that the authors are taking a solid position with respect to reducing the delay to initiation of laser treatment following isotretinoin therapy. “The authors take a strong stance against the old dogma of postponing laser resurfacing for at least 6 months post isotretinoin,” he said. “According to the authors, there is sufficient evidence to support the idea of safely starting laser therapies, including fractional ablative and nonablative, within 1 month post isotretinoin, much sooner than previously suggested.”
He added that the authors point to the fact most experts utilize vascular lasers, such as pulsed-dye, to treat active acne in combination with medical therapy, thus reducing duration and severity of inflammation and potentially reducing further scar formation. “According to this published consensus, such laser therapies can even be used while the patient is actively treated with isotretinoin,” he said.
Dr. Metelitsa noted that the consensus recommendations outline how the choice of device should be guided by the clinical subtype of acne scars.
Dr. Shumaker, Dr. Metelitsa, and the authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Characterizing Counterfeit Dermatologic Devices Sold on Popular E-commerce Websites
To the Editor:
Approved medical devices on the market are substantial capital investments for practitioners. E-commerce websites, such as Alibaba.com (https://www.alibaba.com/) and DHgate.com (https://www.dhgate.com/), sell sham medical devices at a fraction of the cost of authentic products, with sellers often echoing the same treatment claims as legitimate devices that have been cleared by the US Food and Drug Administration (FDA).
In dermatology, devices claiming to perform cryolipolysis, laser skin resurfacing, radiofrequency skin tightening, and more exist on e-commerce websites. These counterfeit medical devices might differ from legitimate devices in ways that affect patient safety and treatment efficacy.1,2 The degree of difference between counterfeit and legitimate devices remains unknown, and potential harm from so-called knockoff devices needs to be critically examined by providers.
In this exploratory study, we characterize counterfeit listings of devices commonly used in dermatology. Using the trademark name of devices as the key terms, we searched Alibaba.com and DHgate.com for listings of counterfeit products. We recorded the total number of listings; the listing name, catalog number, and unit price; and claims of FDA certification. Characteristics of counterfeit listings were summarized using standard descriptive statistics in Microsoft Excel. Continuous variables were summarized with means and ranges.
Six medical devices that had been cleared by the FDA between 2002 and 2012 for use in dermatology were explored, including systems for picosecond and fractionated lasers, monopolar and bipolar radiofrequency skin tightening, cryolipolysis, and nonablative radiofrequency skin resurfacing. Our search of these 6 representative dermatologic devices revealed 47,055 counterfeit product listings on Alibaba.com and DHgate.com. Upon searching these popular e-commerce websites using the device name as the search term, the number of listings varied considerably between the 2 e-commerce websites for the same device and from device to device on the same e-commerce website. On Alibaba.com, the greatest number of listings resulted for picosecond laser (23,622 listings), fractionated laser (15,269), and radiofrequency skin tightening devices (3555); cryolipolysis and nonablative radiofrequency resurfacing devices had notably fewer listings (35 and 38, respectively). On DHGate.com, a similar trend was noted with the most numerous listings for picosecond and fractionated laser systems (2429 and 1345, respectively).
Among the first 10 listings of products on Alibaba.com and DHgate.com for these 6 devices, 10.7% (11 of 103) had advertised claims of FDA clearance on the listing page. Of 103 counterfeit products, China was the country of origin for 100; South Korea for 2; and Thailand for 1. Unit pricing was heterogeneous between the 2 e-commerce websites for the counterfeit listings; pricing for duplicate fractionated laser systems was particularly dissimilar, with an average price on Alibab.com of US $8105.80 and an average price on DHgate.com of US $3409.14. Even on the same e-commerce website, the range of unit pricing differed greatly for dermatologic devices. For example, among the first 10 listings on Alibaba.com for a fractionated laser system, the price ranged from US $2300 to US $32,000.
Counterfeit medical devices are on the rise in dermatology.1,3 Although devices such as radiofrequency and laser systems had thousands of knockoff listings on 2 e-commerce websites, other devices, such as cryolipolysis and body contouring systems, had fewer listings, suggesting heterogeneity in the prevalence of different counterfeit dermatologic devices on the market.
The varied pricing of the top 10 listings for each product and spurious claims of FDA clearance for some listings highlight the lack of regulatory authority over consistent product information on e-commerce websites. Furthermore, differences between characteristics of counterfeit device listings can impede efforts to trace suppliers and increase the opacity of counterfeit purchasing.
Three criteria have been proposed for a device to be considered counterfeit3:
• The device has no proven safety or efficacy among consumers. For example, the substantial threat of copycat devices in dermatology has been demonstrated by reports of burns caused by fake cryolipolysis devices.2
• The device violates patent rights or copy trademarks. Due to the regional nature of intellectual property rights, country-specific filings of patents and trademarks are required if protections are sought internationally. In this study, counterfeit devices originated in China, South Korea, and Thailand, where patent and trademark protections for the original devices do not extend.
• The device is falsely claimed to have been cleared by the FDA or other clinical regulatory authorities. Legitimate medical devices are subject to rounds of safety and compatibility testing using standards set by regulatory bodies, such as the FDA’s Center for Devices and Radiological Health, the International Organization of Standardization, and the International Electrotechnical Commission. Compliance with these safety standards is lost, however, among unregulated internet sales of medical devices. Our search revealed that 10.7% of the top 10 counterfeit device listings for each product explicitly mentioned FDA clearance in the product description. Among the thousands of listings on e-commerce sites, even a fraction that make spurious FDA-clearance claims can mislead consumers.
The issue of counterfeit medical devices has not gone unrecognized globally. In 2013, the World Health Organization created the Global Surveillance and Monitoring System to unify international efforts for reporting substandard, unlicensed, or falsified medical products.4 Although universal monitoring systems can improve detection of counterfeit products, we highlight the alarming continuing ease of purchasing counterfeit dermatologic devices through e-commerce websites. Due to the widespread nature of counterfeiting across all domains of medicine, the onus of curbing counterfeit dermatologic devices might be on dermatology providers to recognize and report such occurrences.
This exploration of counterfeit dermatologic devices revealed a lack of consistency throughout product listings on 2 popular e-commerce websites, Alibaba.com and DHgate.com. Given the alarming availability of these devices on the internet, practitioners should approach the purchase of any device with concern about counterfeiting. Future avenues of study might explore the prevalence of counterfeit devices used in dermatology practices and offer insight on regulation and consumer safety efforts.
- Wang JV, Zachary CB, Saedi N. Counterfeit esthetic devices and patient safety in dermatology. J Cosmet Dermatol. 2018;17:396-397. doi:10.1111/jocd.12526
- Biesman BS, Patel N. Physician alert: beware of counterfeit medical devices. Lasers Surg Med. 2014;46:528‐530. doi:10.1002/lsm.22275
- Stevens WG, Spring MA, Macias LH. Counterfeit medical devices: the money you save up front will cost you big in the end. Aesthet Surg J. 2014;34:786‐788. doi:10.1177/1090820X14529960
- Pisani E. WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. World Health Organization; 2017. Accessed November 21, 2021. https://www.who.int/medicines/regulation/ssffc/publications/GSMSreport_EN.pdf?ua=1
To the Editor:
Approved medical devices on the market are substantial capital investments for practitioners. E-commerce websites, such as Alibaba.com (https://www.alibaba.com/) and DHgate.com (https://www.dhgate.com/), sell sham medical devices at a fraction of the cost of authentic products, with sellers often echoing the same treatment claims as legitimate devices that have been cleared by the US Food and Drug Administration (FDA).
In dermatology, devices claiming to perform cryolipolysis, laser skin resurfacing, radiofrequency skin tightening, and more exist on e-commerce websites. These counterfeit medical devices might differ from legitimate devices in ways that affect patient safety and treatment efficacy.1,2 The degree of difference between counterfeit and legitimate devices remains unknown, and potential harm from so-called knockoff devices needs to be critically examined by providers.
In this exploratory study, we characterize counterfeit listings of devices commonly used in dermatology. Using the trademark name of devices as the key terms, we searched Alibaba.com and DHgate.com for listings of counterfeit products. We recorded the total number of listings; the listing name, catalog number, and unit price; and claims of FDA certification. Characteristics of counterfeit listings were summarized using standard descriptive statistics in Microsoft Excel. Continuous variables were summarized with means and ranges.
Six medical devices that had been cleared by the FDA between 2002 and 2012 for use in dermatology were explored, including systems for picosecond and fractionated lasers, monopolar and bipolar radiofrequency skin tightening, cryolipolysis, and nonablative radiofrequency skin resurfacing. Our search of these 6 representative dermatologic devices revealed 47,055 counterfeit product listings on Alibaba.com and DHgate.com. Upon searching these popular e-commerce websites using the device name as the search term, the number of listings varied considerably between the 2 e-commerce websites for the same device and from device to device on the same e-commerce website. On Alibaba.com, the greatest number of listings resulted for picosecond laser (23,622 listings), fractionated laser (15,269), and radiofrequency skin tightening devices (3555); cryolipolysis and nonablative radiofrequency resurfacing devices had notably fewer listings (35 and 38, respectively). On DHGate.com, a similar trend was noted with the most numerous listings for picosecond and fractionated laser systems (2429 and 1345, respectively).
Among the first 10 listings of products on Alibaba.com and DHgate.com for these 6 devices, 10.7% (11 of 103) had advertised claims of FDA clearance on the listing page. Of 103 counterfeit products, China was the country of origin for 100; South Korea for 2; and Thailand for 1. Unit pricing was heterogeneous between the 2 e-commerce websites for the counterfeit listings; pricing for duplicate fractionated laser systems was particularly dissimilar, with an average price on Alibab.com of US $8105.80 and an average price on DHgate.com of US $3409.14. Even on the same e-commerce website, the range of unit pricing differed greatly for dermatologic devices. For example, among the first 10 listings on Alibaba.com for a fractionated laser system, the price ranged from US $2300 to US $32,000.
Counterfeit medical devices are on the rise in dermatology.1,3 Although devices such as radiofrequency and laser systems had thousands of knockoff listings on 2 e-commerce websites, other devices, such as cryolipolysis and body contouring systems, had fewer listings, suggesting heterogeneity in the prevalence of different counterfeit dermatologic devices on the market.
The varied pricing of the top 10 listings for each product and spurious claims of FDA clearance for some listings highlight the lack of regulatory authority over consistent product information on e-commerce websites. Furthermore, differences between characteristics of counterfeit device listings can impede efforts to trace suppliers and increase the opacity of counterfeit purchasing.
Three criteria have been proposed for a device to be considered counterfeit3:
• The device has no proven safety or efficacy among consumers. For example, the substantial threat of copycat devices in dermatology has been demonstrated by reports of burns caused by fake cryolipolysis devices.2
• The device violates patent rights or copy trademarks. Due to the regional nature of intellectual property rights, country-specific filings of patents and trademarks are required if protections are sought internationally. In this study, counterfeit devices originated in China, South Korea, and Thailand, where patent and trademark protections for the original devices do not extend.
• The device is falsely claimed to have been cleared by the FDA or other clinical regulatory authorities. Legitimate medical devices are subject to rounds of safety and compatibility testing using standards set by regulatory bodies, such as the FDA’s Center for Devices and Radiological Health, the International Organization of Standardization, and the International Electrotechnical Commission. Compliance with these safety standards is lost, however, among unregulated internet sales of medical devices. Our search revealed that 10.7% of the top 10 counterfeit device listings for each product explicitly mentioned FDA clearance in the product description. Among the thousands of listings on e-commerce sites, even a fraction that make spurious FDA-clearance claims can mislead consumers.
The issue of counterfeit medical devices has not gone unrecognized globally. In 2013, the World Health Organization created the Global Surveillance and Monitoring System to unify international efforts for reporting substandard, unlicensed, or falsified medical products.4 Although universal monitoring systems can improve detection of counterfeit products, we highlight the alarming continuing ease of purchasing counterfeit dermatologic devices through e-commerce websites. Due to the widespread nature of counterfeiting across all domains of medicine, the onus of curbing counterfeit dermatologic devices might be on dermatology providers to recognize and report such occurrences.
This exploration of counterfeit dermatologic devices revealed a lack of consistency throughout product listings on 2 popular e-commerce websites, Alibaba.com and DHgate.com. Given the alarming availability of these devices on the internet, practitioners should approach the purchase of any device with concern about counterfeiting. Future avenues of study might explore the prevalence of counterfeit devices used in dermatology practices and offer insight on regulation and consumer safety efforts.
To the Editor:
Approved medical devices on the market are substantial capital investments for practitioners. E-commerce websites, such as Alibaba.com (https://www.alibaba.com/) and DHgate.com (https://www.dhgate.com/), sell sham medical devices at a fraction of the cost of authentic products, with sellers often echoing the same treatment claims as legitimate devices that have been cleared by the US Food and Drug Administration (FDA).
In dermatology, devices claiming to perform cryolipolysis, laser skin resurfacing, radiofrequency skin tightening, and more exist on e-commerce websites. These counterfeit medical devices might differ from legitimate devices in ways that affect patient safety and treatment efficacy.1,2 The degree of difference between counterfeit and legitimate devices remains unknown, and potential harm from so-called knockoff devices needs to be critically examined by providers.
In this exploratory study, we characterize counterfeit listings of devices commonly used in dermatology. Using the trademark name of devices as the key terms, we searched Alibaba.com and DHgate.com for listings of counterfeit products. We recorded the total number of listings; the listing name, catalog number, and unit price; and claims of FDA certification. Characteristics of counterfeit listings were summarized using standard descriptive statistics in Microsoft Excel. Continuous variables were summarized with means and ranges.
Six medical devices that had been cleared by the FDA between 2002 and 2012 for use in dermatology were explored, including systems for picosecond and fractionated lasers, monopolar and bipolar radiofrequency skin tightening, cryolipolysis, and nonablative radiofrequency skin resurfacing. Our search of these 6 representative dermatologic devices revealed 47,055 counterfeit product listings on Alibaba.com and DHgate.com. Upon searching these popular e-commerce websites using the device name as the search term, the number of listings varied considerably between the 2 e-commerce websites for the same device and from device to device on the same e-commerce website. On Alibaba.com, the greatest number of listings resulted for picosecond laser (23,622 listings), fractionated laser (15,269), and radiofrequency skin tightening devices (3555); cryolipolysis and nonablative radiofrequency resurfacing devices had notably fewer listings (35 and 38, respectively). On DHGate.com, a similar trend was noted with the most numerous listings for picosecond and fractionated laser systems (2429 and 1345, respectively).
Among the first 10 listings of products on Alibaba.com and DHgate.com for these 6 devices, 10.7% (11 of 103) had advertised claims of FDA clearance on the listing page. Of 103 counterfeit products, China was the country of origin for 100; South Korea for 2; and Thailand for 1. Unit pricing was heterogeneous between the 2 e-commerce websites for the counterfeit listings; pricing for duplicate fractionated laser systems was particularly dissimilar, with an average price on Alibab.com of US $8105.80 and an average price on DHgate.com of US $3409.14. Even on the same e-commerce website, the range of unit pricing differed greatly for dermatologic devices. For example, among the first 10 listings on Alibaba.com for a fractionated laser system, the price ranged from US $2300 to US $32,000.
Counterfeit medical devices are on the rise in dermatology.1,3 Although devices such as radiofrequency and laser systems had thousands of knockoff listings on 2 e-commerce websites, other devices, such as cryolipolysis and body contouring systems, had fewer listings, suggesting heterogeneity in the prevalence of different counterfeit dermatologic devices on the market.
The varied pricing of the top 10 listings for each product and spurious claims of FDA clearance for some listings highlight the lack of regulatory authority over consistent product information on e-commerce websites. Furthermore, differences between characteristics of counterfeit device listings can impede efforts to trace suppliers and increase the opacity of counterfeit purchasing.
Three criteria have been proposed for a device to be considered counterfeit3:
• The device has no proven safety or efficacy among consumers. For example, the substantial threat of copycat devices in dermatology has been demonstrated by reports of burns caused by fake cryolipolysis devices.2
• The device violates patent rights or copy trademarks. Due to the regional nature of intellectual property rights, country-specific filings of patents and trademarks are required if protections are sought internationally. In this study, counterfeit devices originated in China, South Korea, and Thailand, where patent and trademark protections for the original devices do not extend.
• The device is falsely claimed to have been cleared by the FDA or other clinical regulatory authorities. Legitimate medical devices are subject to rounds of safety and compatibility testing using standards set by regulatory bodies, such as the FDA’s Center for Devices and Radiological Health, the International Organization of Standardization, and the International Electrotechnical Commission. Compliance with these safety standards is lost, however, among unregulated internet sales of medical devices. Our search revealed that 10.7% of the top 10 counterfeit device listings for each product explicitly mentioned FDA clearance in the product description. Among the thousands of listings on e-commerce sites, even a fraction that make spurious FDA-clearance claims can mislead consumers.
The issue of counterfeit medical devices has not gone unrecognized globally. In 2013, the World Health Organization created the Global Surveillance and Monitoring System to unify international efforts for reporting substandard, unlicensed, or falsified medical products.4 Although universal monitoring systems can improve detection of counterfeit products, we highlight the alarming continuing ease of purchasing counterfeit dermatologic devices through e-commerce websites. Due to the widespread nature of counterfeiting across all domains of medicine, the onus of curbing counterfeit dermatologic devices might be on dermatology providers to recognize and report such occurrences.
This exploration of counterfeit dermatologic devices revealed a lack of consistency throughout product listings on 2 popular e-commerce websites, Alibaba.com and DHgate.com. Given the alarming availability of these devices on the internet, practitioners should approach the purchase of any device with concern about counterfeiting. Future avenues of study might explore the prevalence of counterfeit devices used in dermatology practices and offer insight on regulation and consumer safety efforts.
- Wang JV, Zachary CB, Saedi N. Counterfeit esthetic devices and patient safety in dermatology. J Cosmet Dermatol. 2018;17:396-397. doi:10.1111/jocd.12526
- Biesman BS, Patel N. Physician alert: beware of counterfeit medical devices. Lasers Surg Med. 2014;46:528‐530. doi:10.1002/lsm.22275
- Stevens WG, Spring MA, Macias LH. Counterfeit medical devices: the money you save up front will cost you big in the end. Aesthet Surg J. 2014;34:786‐788. doi:10.1177/1090820X14529960
- Pisani E. WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. World Health Organization; 2017. Accessed November 21, 2021. https://www.who.int/medicines/regulation/ssffc/publications/GSMSreport_EN.pdf?ua=1
- Wang JV, Zachary CB, Saedi N. Counterfeit esthetic devices and patient safety in dermatology. J Cosmet Dermatol. 2018;17:396-397. doi:10.1111/jocd.12526
- Biesman BS, Patel N. Physician alert: beware of counterfeit medical devices. Lasers Surg Med. 2014;46:528‐530. doi:10.1002/lsm.22275
- Stevens WG, Spring MA, Macias LH. Counterfeit medical devices: the money you save up front will cost you big in the end. Aesthet Surg J. 2014;34:786‐788. doi:10.1177/1090820X14529960
- Pisani E. WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. World Health Organization; 2017. Accessed November 21, 2021. https://www.who.int/medicines/regulation/ssffc/publications/GSMSreport_EN.pdf?ua=1
Practice Points
- Among thousands of counterfeit dermatologic listings, there is great heterogeneity in the number of listings per different subtypes of dermatologic devices, device descriptions, and unit pricing, along with false claims of US Food and Drug Administration clearance.
- Given the prevalence of counterfeit medical devices readily available for purchase online, dermatology practitioners should be wary of the authenticity of any medical device purchased for clinical use.
Sea buckthorn: What is it and what is it good for?
To avoid jumping on the bandwagon of another ingredient trend, we sought to examine the scientific background and properties of sea buckthorn oil and it’s utility for the skin.
Sea buckthorn (Hippophae rhamnoides) – also known as a Siberian pineapple tree, and as sandthorn, sallowthorn, or seaberry – is a thorny, dioecious shrub (or tree) in the oleaster family. It can grow up to 23 feet high and is found in coastal sea cliff areas and on mountain slopes of Western Europe, and in dry sandy areas of Asia Minor and Central Asia, Siberia, China, and Tibet. Common sea buckthorn flowers in late April and early May, producing a large number of small, green and brown flowers, turning into edible, usually yellow or orange round berries. The berries have a bitter, sour taste and have a mild aroma, resembling that of a pineapple. The fruit contains a small stone that covers an oily seed.
The berries are a source of antioxidant vitamins, flavonoids, and organic acids, and when pressed, produce a juice that separates into three layers: a thick cream (upper layer), a combination of saturated and unsaturated fatty acids (middle layer), and juice that is a source of fat (lower layer). The berries contain mainly vitamin C, but also vitamin A (alpha- and beta-carotene) and a mixture of other carotenoids, as well as varying concentrations of tocopherols (vitamin E), folic acid, and vitamin B complex–group vitamins.
In addition to flavonoids, the berries contain catechins and procyanidins, cyclitols, phospholipids, tannins, sugars (galactose, fructose, xylose), organic acids (maleic acid, oxalic acid, malic acid, tartaric acid), phenolic acids (such as ferulic acid), and fatty oil. The amount of vitamin C content varies with the variety of the plant and where it is found. The oil of sea buckthorn may be extracted from two parts of the plant, with mechanical cold pressing of seeds (up to 12.5% weight as oil content) and fruit pulp (8%-12% oil content).
Among vegetable oils, sea buckthorn fruit oil has the highest content of palmitoleic acid (omega-7).
Fruit and seed oils contain tocotrienols and plant sterols. Pulp sea buckthorn oil has a high carotenoid content, as opposed to seed oil, and in Mongolia, Russia, and China, is used as a topical therapy for skin burns.
Other significant fatty acids found in sea buckthorn oil are saturated fatty acids (palmitic acid and stearic acid) and polyunsaturated fatty acids, which include alpha-linolenic acid (omega-3), gamma-linolenic acid (omega-6), linolic acid (omega-6), oleic acid (omega-9), and eicosanoic acid (omega-9). Gamma-linoleic acid in particular is reduced in dry skin conditions, such as aging and atopic dermatitis. The human body can produce some gamma-linolenic acid, oleic acid, and palmitoleic acid, but not linolic acid and alpha-linolenic acid. The addition of these substances to diet or skin care has been found to be beneficial in improving dryness and the skin barrier.
In addition, linolic acid, a natural component of human sebum, has been noted to be decreased in the sebum of people with acne-prone skin. Preliminary evidence indicates that dietary supplements containing fatty acids such as docosahexaenoic acid, sea buckthorn oil, and hemp seed oil may decrease the severity of atopic dermatitis.
Besides use in topical skin care and cosmetic preparations, sea buckthorn has also been used successfully in the treatment of chronic gastric ulcer disease, inflammation of the vagina and cervix, and cervical erosion. The bark and leaves of sea buckthorn used to be applied to treat diarrhea and dermatologic conditions, while berry oil has been applied topically or taken orally to soften the skin.
In traditional Indian, Chinese, and Tibetan medicines, sea buckthorn berries are used for medicinal purposes, as their ingredients were thought to have a beneficial effect on the function of the alimentary, respiratory, and circulatory systems. Current studies and uses are now confirming their utility experienced over hundreds of years.
Harvesting sea buckthorn fruit is difficult because of dense thorn arrangement among the berries. Therefore, sometimes the only way to obtain fruit is to remove the entire branch of the shrub, which reduces future crops. For this reason berries can only be harvested once every 2 years.
Sea buckthorn has interesting properties and could be of benefit in topical skin care, as long as it is not overharvested or harvested in a way that has a detrimental impact on the environment.
Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
References
United States Department of Agriculture. PLANTS Profile for Hippophae rhamnoides (seaberry). 2007.
Zielińska A and Nowak I. Lipids Health Dis. 2017 May 19;16(1):95.
Reynolds KA et al. Int J Dermatol. 2019 Dec;58(12):1371-6.
To avoid jumping on the bandwagon of another ingredient trend, we sought to examine the scientific background and properties of sea buckthorn oil and it’s utility for the skin.
Sea buckthorn (Hippophae rhamnoides) – also known as a Siberian pineapple tree, and as sandthorn, sallowthorn, or seaberry – is a thorny, dioecious shrub (or tree) in the oleaster family. It can grow up to 23 feet high and is found in coastal sea cliff areas and on mountain slopes of Western Europe, and in dry sandy areas of Asia Minor and Central Asia, Siberia, China, and Tibet. Common sea buckthorn flowers in late April and early May, producing a large number of small, green and brown flowers, turning into edible, usually yellow or orange round berries. The berries have a bitter, sour taste and have a mild aroma, resembling that of a pineapple. The fruit contains a small stone that covers an oily seed.
The berries are a source of antioxidant vitamins, flavonoids, and organic acids, and when pressed, produce a juice that separates into three layers: a thick cream (upper layer), a combination of saturated and unsaturated fatty acids (middle layer), and juice that is a source of fat (lower layer). The berries contain mainly vitamin C, but also vitamin A (alpha- and beta-carotene) and a mixture of other carotenoids, as well as varying concentrations of tocopherols (vitamin E), folic acid, and vitamin B complex–group vitamins.
In addition to flavonoids, the berries contain catechins and procyanidins, cyclitols, phospholipids, tannins, sugars (galactose, fructose, xylose), organic acids (maleic acid, oxalic acid, malic acid, tartaric acid), phenolic acids (such as ferulic acid), and fatty oil. The amount of vitamin C content varies with the variety of the plant and where it is found. The oil of sea buckthorn may be extracted from two parts of the plant, with mechanical cold pressing of seeds (up to 12.5% weight as oil content) and fruit pulp (8%-12% oil content).
Among vegetable oils, sea buckthorn fruit oil has the highest content of palmitoleic acid (omega-7).
Fruit and seed oils contain tocotrienols and plant sterols. Pulp sea buckthorn oil has a high carotenoid content, as opposed to seed oil, and in Mongolia, Russia, and China, is used as a topical therapy for skin burns.
Other significant fatty acids found in sea buckthorn oil are saturated fatty acids (palmitic acid and stearic acid) and polyunsaturated fatty acids, which include alpha-linolenic acid (omega-3), gamma-linolenic acid (omega-6), linolic acid (omega-6), oleic acid (omega-9), and eicosanoic acid (omega-9). Gamma-linoleic acid in particular is reduced in dry skin conditions, such as aging and atopic dermatitis. The human body can produce some gamma-linolenic acid, oleic acid, and palmitoleic acid, but not linolic acid and alpha-linolenic acid. The addition of these substances to diet or skin care has been found to be beneficial in improving dryness and the skin barrier.
In addition, linolic acid, a natural component of human sebum, has been noted to be decreased in the sebum of people with acne-prone skin. Preliminary evidence indicates that dietary supplements containing fatty acids such as docosahexaenoic acid, sea buckthorn oil, and hemp seed oil may decrease the severity of atopic dermatitis.
Besides use in topical skin care and cosmetic preparations, sea buckthorn has also been used successfully in the treatment of chronic gastric ulcer disease, inflammation of the vagina and cervix, and cervical erosion. The bark and leaves of sea buckthorn used to be applied to treat diarrhea and dermatologic conditions, while berry oil has been applied topically or taken orally to soften the skin.
In traditional Indian, Chinese, and Tibetan medicines, sea buckthorn berries are used for medicinal purposes, as their ingredients were thought to have a beneficial effect on the function of the alimentary, respiratory, and circulatory systems. Current studies and uses are now confirming their utility experienced over hundreds of years.
Harvesting sea buckthorn fruit is difficult because of dense thorn arrangement among the berries. Therefore, sometimes the only way to obtain fruit is to remove the entire branch of the shrub, which reduces future crops. For this reason berries can only be harvested once every 2 years.
Sea buckthorn has interesting properties and could be of benefit in topical skin care, as long as it is not overharvested or harvested in a way that has a detrimental impact on the environment.
Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
References
United States Department of Agriculture. PLANTS Profile for Hippophae rhamnoides (seaberry). 2007.
Zielińska A and Nowak I. Lipids Health Dis. 2017 May 19;16(1):95.
Reynolds KA et al. Int J Dermatol. 2019 Dec;58(12):1371-6.
To avoid jumping on the bandwagon of another ingredient trend, we sought to examine the scientific background and properties of sea buckthorn oil and it’s utility for the skin.
Sea buckthorn (Hippophae rhamnoides) – also known as a Siberian pineapple tree, and as sandthorn, sallowthorn, or seaberry – is a thorny, dioecious shrub (or tree) in the oleaster family. It can grow up to 23 feet high and is found in coastal sea cliff areas and on mountain slopes of Western Europe, and in dry sandy areas of Asia Minor and Central Asia, Siberia, China, and Tibet. Common sea buckthorn flowers in late April and early May, producing a large number of small, green and brown flowers, turning into edible, usually yellow or orange round berries. The berries have a bitter, sour taste and have a mild aroma, resembling that of a pineapple. The fruit contains a small stone that covers an oily seed.
The berries are a source of antioxidant vitamins, flavonoids, and organic acids, and when pressed, produce a juice that separates into three layers: a thick cream (upper layer), a combination of saturated and unsaturated fatty acids (middle layer), and juice that is a source of fat (lower layer). The berries contain mainly vitamin C, but also vitamin A (alpha- and beta-carotene) and a mixture of other carotenoids, as well as varying concentrations of tocopherols (vitamin E), folic acid, and vitamin B complex–group vitamins.
In addition to flavonoids, the berries contain catechins and procyanidins, cyclitols, phospholipids, tannins, sugars (galactose, fructose, xylose), organic acids (maleic acid, oxalic acid, malic acid, tartaric acid), phenolic acids (such as ferulic acid), and fatty oil. The amount of vitamin C content varies with the variety of the plant and where it is found. The oil of sea buckthorn may be extracted from two parts of the plant, with mechanical cold pressing of seeds (up to 12.5% weight as oil content) and fruit pulp (8%-12% oil content).
Among vegetable oils, sea buckthorn fruit oil has the highest content of palmitoleic acid (omega-7).
Fruit and seed oils contain tocotrienols and plant sterols. Pulp sea buckthorn oil has a high carotenoid content, as opposed to seed oil, and in Mongolia, Russia, and China, is used as a topical therapy for skin burns.
Other significant fatty acids found in sea buckthorn oil are saturated fatty acids (palmitic acid and stearic acid) and polyunsaturated fatty acids, which include alpha-linolenic acid (omega-3), gamma-linolenic acid (omega-6), linolic acid (omega-6), oleic acid (omega-9), and eicosanoic acid (omega-9). Gamma-linoleic acid in particular is reduced in dry skin conditions, such as aging and atopic dermatitis. The human body can produce some gamma-linolenic acid, oleic acid, and palmitoleic acid, but not linolic acid and alpha-linolenic acid. The addition of these substances to diet or skin care has been found to be beneficial in improving dryness and the skin barrier.
In addition, linolic acid, a natural component of human sebum, has been noted to be decreased in the sebum of people with acne-prone skin. Preliminary evidence indicates that dietary supplements containing fatty acids such as docosahexaenoic acid, sea buckthorn oil, and hemp seed oil may decrease the severity of atopic dermatitis.
Besides use in topical skin care and cosmetic preparations, sea buckthorn has also been used successfully in the treatment of chronic gastric ulcer disease, inflammation of the vagina and cervix, and cervical erosion. The bark and leaves of sea buckthorn used to be applied to treat diarrhea and dermatologic conditions, while berry oil has been applied topically or taken orally to soften the skin.
In traditional Indian, Chinese, and Tibetan medicines, sea buckthorn berries are used for medicinal purposes, as their ingredients were thought to have a beneficial effect on the function of the alimentary, respiratory, and circulatory systems. Current studies and uses are now confirming their utility experienced over hundreds of years.
Harvesting sea buckthorn fruit is difficult because of dense thorn arrangement among the berries. Therefore, sometimes the only way to obtain fruit is to remove the entire branch of the shrub, which reduces future crops. For this reason berries can only be harvested once every 2 years.
Sea buckthorn has interesting properties and could be of benefit in topical skin care, as long as it is not overharvested or harvested in a way that has a detrimental impact on the environment.
Dr. Wesley and Lily Talakoub, MD, are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.
References
United States Department of Agriculture. PLANTS Profile for Hippophae rhamnoides (seaberry). 2007.
Zielińska A and Nowak I. Lipids Health Dis. 2017 May 19;16(1):95.
Reynolds KA et al. Int J Dermatol. 2019 Dec;58(12):1371-6.
Striae gravidarum: More than a ‘nuisance,’ say researchers
In the study of healthy pregnant women, “we found that SG can be associated with a host of negative reactions reflecting increased psychological and emotional distress,” reported Kaveri Karhade, MD, from the Berman Skin Institute, Los Altos, Calif., and coauthors from the University of Michigan, Ann Arbor. Dr. Karhade was with the department of dermatology at the University of Michigan at the time the study was conducted.
“We suggest that health care providers should avoid thinking of SG as merely a cosmetic ‘nuisance,’ ” they wrote in an article published in the International Journal of Women’s Dermatology. “Instead, it would be reasonable for providers to approach SG like other dermatologic concerns, and to consider asking patients whether SG cause emotional distress and whether prevention or treatment strategies should be attempted, even if not completely effective and potentially costly.”
The investigators did not evaluate treatments, but Frank Wang, MD, senior author of the study and professor of clinical dermatology at the University of Michigan Medicine, said in an interview that, “while they aren’t completely effective, some treatments can still help.” In addition, “recommending something also shows that you are listening to patients’ concerns – taking their concerns and skin lesions seriously,” he said.
Patient survey
The authors conducted a cross-sectional survey of 116 healthy pregnant women with SG. Participants were asked about the emotional and psychological effects of the lesions and how SG affects quality of life. The survey was modeled on questions from the Dermatology Life Quality Index, which asks about the impact of skin disease on embarrassment/self-consciousness, clothing choice, leisure activities, and interpersonal problems. “Content of questions was also devised from direct discussion with pregnant women attending clinic appointments or participating in other research studies on SG at our institution, and discussion with expert colleagues in obstetrics and dermatology,” the authors explained.
The survey consisted of 35 questions concerning demographics, pregnancy characteristics, personal and family history of SG, specific physical concerns about SG, impact of SG on attitude toward pregnancy, willingness to prevent SG or seek treatment, severity of SG (self-evaluated), the impact of SG on specific life-quality facets, and the location of lesions.
About two-thirds of respondents were aged 25-36 years and were White; the remainder self-identified as Asian, Black, Native American, or “other.” Most women reported “average” weight gain during the current pregnancy. Almost half of participants (45%) reporting a history of SG from prior pregnancies, and 65% reported a family history of SG.
The abdomen was identified most frequently as the location of SG (75%), followed by the breasts (43%), hips (43%), thighs (36%), buttocks (19%), and other areas (6%).
For most women (75%), permanency of the lesions was their top concern. About half (51%) reported that they had attempted to prevent SG, mostly with topical creams or oils. Three-quarters (75%) expressed interest in seeking treatment for SG, but this percentage dropped significantly to 33% (P =.008) if that treatment would not be covered by insurance.
Regarding the psychological impact of SG, embarrassment/self-consciousness correlated most strongly with lesion severity, followed by general quality of life, impact on choice of attire, impact on self-image/self-esteem, feelings of anxiety/depression related to SG, alteration of social/leisure activities related to SG (all P < .0001), and creation of interpersonal problems related to SG (P = .02).
The investigators also found that an increase in the effect of SG on self-image/self-esteem was “moderately associated” with younger age (P < .001) and that increased embarrassment related to SG was “moderately associated” with weight gain during pregnancy (P < .001).
“For years, stretch marks have been a topic to avoid and something many women try to hide,” Timothy Johnson, MD, professor of obstetrics and gynecology at the University of Michigan and coauthor of the study, said in a press release from the university. “Pregnant women talk about stretch marks with me every single week at clinic, and it’s time we break the stigma and start talking about them openly with all patients. ... By doing this study, we have an opportunity to normalize stretch marks in the context of all other dermatological conditions.”
Asked to comment on the findings, Tina Alster, MD, director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology at Georgetown University, Washington, said her 3 decades of clinical experience support the authors’ findings. “Most patients who have striae are very self-conscious about them and report that their presence has negatively impacted their quality of life and self-confidence,” she said in an interview. “Of course, patients who come to my office are interested in having them treated, so my patient subset is skewed.”
She said treatment strategies that she discusses with patients include topical retinol/retinoids, which she said provide “low clinical response”; microneedling, which provides “marked” clinical response; and nonablative laser treatment, which provides “good” clinical response.
Considering particular patient characteristics, including budget, Dr. Alster said, “For those on a limited budget, I would propose daily use of a topical retinol, despite the low clinical effect. Many retinol-containing products are available over the counter. Prescription-strength retinoic acid tends to be pricey, often costing as much as in-office treatments.” Medical microneedling (not the cosmetic “roller” microneedling performed by aestheticians), she added, “gives the best results for the money and produces clinical results that mirror those achieved with lasers.”
Dr. Wang agreed that even recommending less expensive and less efficacious options such as over-the-counter creams can help alleviate patients’ concerns. “It shows that you are being holistic – not just caring for medical issues around pregnancy, but that you also take the emotional/psychological concerns of pregnant individuals and new parents seriously and that you recognize the impact of skin problems on quality of life. In the end, recommending something – in other words, providing some options, like creams or other therapies, for instance – is still, in my opinion, better than not recommending anything.”
Dr. Wang is involved with a study that is currently enrolling patients and that is evaluating the formation of early SG, which includes performing skin biopsies as soon as lesions appear.
The study had no funding. The study authors and Dr. Alster disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In the study of healthy pregnant women, “we found that SG can be associated with a host of negative reactions reflecting increased psychological and emotional distress,” reported Kaveri Karhade, MD, from the Berman Skin Institute, Los Altos, Calif., and coauthors from the University of Michigan, Ann Arbor. Dr. Karhade was with the department of dermatology at the University of Michigan at the time the study was conducted.
“We suggest that health care providers should avoid thinking of SG as merely a cosmetic ‘nuisance,’ ” they wrote in an article published in the International Journal of Women’s Dermatology. “Instead, it would be reasonable for providers to approach SG like other dermatologic concerns, and to consider asking patients whether SG cause emotional distress and whether prevention or treatment strategies should be attempted, even if not completely effective and potentially costly.”
The investigators did not evaluate treatments, but Frank Wang, MD, senior author of the study and professor of clinical dermatology at the University of Michigan Medicine, said in an interview that, “while they aren’t completely effective, some treatments can still help.” In addition, “recommending something also shows that you are listening to patients’ concerns – taking their concerns and skin lesions seriously,” he said.
Patient survey
The authors conducted a cross-sectional survey of 116 healthy pregnant women with SG. Participants were asked about the emotional and psychological effects of the lesions and how SG affects quality of life. The survey was modeled on questions from the Dermatology Life Quality Index, which asks about the impact of skin disease on embarrassment/self-consciousness, clothing choice, leisure activities, and interpersonal problems. “Content of questions was also devised from direct discussion with pregnant women attending clinic appointments or participating in other research studies on SG at our institution, and discussion with expert colleagues in obstetrics and dermatology,” the authors explained.
The survey consisted of 35 questions concerning demographics, pregnancy characteristics, personal and family history of SG, specific physical concerns about SG, impact of SG on attitude toward pregnancy, willingness to prevent SG or seek treatment, severity of SG (self-evaluated), the impact of SG on specific life-quality facets, and the location of lesions.
About two-thirds of respondents were aged 25-36 years and were White; the remainder self-identified as Asian, Black, Native American, or “other.” Most women reported “average” weight gain during the current pregnancy. Almost half of participants (45%) reporting a history of SG from prior pregnancies, and 65% reported a family history of SG.
The abdomen was identified most frequently as the location of SG (75%), followed by the breasts (43%), hips (43%), thighs (36%), buttocks (19%), and other areas (6%).
For most women (75%), permanency of the lesions was their top concern. About half (51%) reported that they had attempted to prevent SG, mostly with topical creams or oils. Three-quarters (75%) expressed interest in seeking treatment for SG, but this percentage dropped significantly to 33% (P =.008) if that treatment would not be covered by insurance.
Regarding the psychological impact of SG, embarrassment/self-consciousness correlated most strongly with lesion severity, followed by general quality of life, impact on choice of attire, impact on self-image/self-esteem, feelings of anxiety/depression related to SG, alteration of social/leisure activities related to SG (all P < .0001), and creation of interpersonal problems related to SG (P = .02).
The investigators also found that an increase in the effect of SG on self-image/self-esteem was “moderately associated” with younger age (P < .001) and that increased embarrassment related to SG was “moderately associated” with weight gain during pregnancy (P < .001).
“For years, stretch marks have been a topic to avoid and something many women try to hide,” Timothy Johnson, MD, professor of obstetrics and gynecology at the University of Michigan and coauthor of the study, said in a press release from the university. “Pregnant women talk about stretch marks with me every single week at clinic, and it’s time we break the stigma and start talking about them openly with all patients. ... By doing this study, we have an opportunity to normalize stretch marks in the context of all other dermatological conditions.”
Asked to comment on the findings, Tina Alster, MD, director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology at Georgetown University, Washington, said her 3 decades of clinical experience support the authors’ findings. “Most patients who have striae are very self-conscious about them and report that their presence has negatively impacted their quality of life and self-confidence,” she said in an interview. “Of course, patients who come to my office are interested in having them treated, so my patient subset is skewed.”
She said treatment strategies that she discusses with patients include topical retinol/retinoids, which she said provide “low clinical response”; microneedling, which provides “marked” clinical response; and nonablative laser treatment, which provides “good” clinical response.
Considering particular patient characteristics, including budget, Dr. Alster said, “For those on a limited budget, I would propose daily use of a topical retinol, despite the low clinical effect. Many retinol-containing products are available over the counter. Prescription-strength retinoic acid tends to be pricey, often costing as much as in-office treatments.” Medical microneedling (not the cosmetic “roller” microneedling performed by aestheticians), she added, “gives the best results for the money and produces clinical results that mirror those achieved with lasers.”
Dr. Wang agreed that even recommending less expensive and less efficacious options such as over-the-counter creams can help alleviate patients’ concerns. “It shows that you are being holistic – not just caring for medical issues around pregnancy, but that you also take the emotional/psychological concerns of pregnant individuals and new parents seriously and that you recognize the impact of skin problems on quality of life. In the end, recommending something – in other words, providing some options, like creams or other therapies, for instance – is still, in my opinion, better than not recommending anything.”
Dr. Wang is involved with a study that is currently enrolling patients and that is evaluating the formation of early SG, which includes performing skin biopsies as soon as lesions appear.
The study had no funding. The study authors and Dr. Alster disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In the study of healthy pregnant women, “we found that SG can be associated with a host of negative reactions reflecting increased psychological and emotional distress,” reported Kaveri Karhade, MD, from the Berman Skin Institute, Los Altos, Calif., and coauthors from the University of Michigan, Ann Arbor. Dr. Karhade was with the department of dermatology at the University of Michigan at the time the study was conducted.
“We suggest that health care providers should avoid thinking of SG as merely a cosmetic ‘nuisance,’ ” they wrote in an article published in the International Journal of Women’s Dermatology. “Instead, it would be reasonable for providers to approach SG like other dermatologic concerns, and to consider asking patients whether SG cause emotional distress and whether prevention or treatment strategies should be attempted, even if not completely effective and potentially costly.”
The investigators did not evaluate treatments, but Frank Wang, MD, senior author of the study and professor of clinical dermatology at the University of Michigan Medicine, said in an interview that, “while they aren’t completely effective, some treatments can still help.” In addition, “recommending something also shows that you are listening to patients’ concerns – taking their concerns and skin lesions seriously,” he said.
Patient survey
The authors conducted a cross-sectional survey of 116 healthy pregnant women with SG. Participants were asked about the emotional and psychological effects of the lesions and how SG affects quality of life. The survey was modeled on questions from the Dermatology Life Quality Index, which asks about the impact of skin disease on embarrassment/self-consciousness, clothing choice, leisure activities, and interpersonal problems. “Content of questions was also devised from direct discussion with pregnant women attending clinic appointments or participating in other research studies on SG at our institution, and discussion with expert colleagues in obstetrics and dermatology,” the authors explained.
The survey consisted of 35 questions concerning demographics, pregnancy characteristics, personal and family history of SG, specific physical concerns about SG, impact of SG on attitude toward pregnancy, willingness to prevent SG or seek treatment, severity of SG (self-evaluated), the impact of SG on specific life-quality facets, and the location of lesions.
About two-thirds of respondents were aged 25-36 years and were White; the remainder self-identified as Asian, Black, Native American, or “other.” Most women reported “average” weight gain during the current pregnancy. Almost half of participants (45%) reporting a history of SG from prior pregnancies, and 65% reported a family history of SG.
The abdomen was identified most frequently as the location of SG (75%), followed by the breasts (43%), hips (43%), thighs (36%), buttocks (19%), and other areas (6%).
For most women (75%), permanency of the lesions was their top concern. About half (51%) reported that they had attempted to prevent SG, mostly with topical creams or oils. Three-quarters (75%) expressed interest in seeking treatment for SG, but this percentage dropped significantly to 33% (P =.008) if that treatment would not be covered by insurance.
Regarding the psychological impact of SG, embarrassment/self-consciousness correlated most strongly with lesion severity, followed by general quality of life, impact on choice of attire, impact on self-image/self-esteem, feelings of anxiety/depression related to SG, alteration of social/leisure activities related to SG (all P < .0001), and creation of interpersonal problems related to SG (P = .02).
The investigators also found that an increase in the effect of SG on self-image/self-esteem was “moderately associated” with younger age (P < .001) and that increased embarrassment related to SG was “moderately associated” with weight gain during pregnancy (P < .001).
“For years, stretch marks have been a topic to avoid and something many women try to hide,” Timothy Johnson, MD, professor of obstetrics and gynecology at the University of Michigan and coauthor of the study, said in a press release from the university. “Pregnant women talk about stretch marks with me every single week at clinic, and it’s time we break the stigma and start talking about them openly with all patients. ... By doing this study, we have an opportunity to normalize stretch marks in the context of all other dermatological conditions.”
Asked to comment on the findings, Tina Alster, MD, director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology at Georgetown University, Washington, said her 3 decades of clinical experience support the authors’ findings. “Most patients who have striae are very self-conscious about them and report that their presence has negatively impacted their quality of life and self-confidence,” she said in an interview. “Of course, patients who come to my office are interested in having them treated, so my patient subset is skewed.”
She said treatment strategies that she discusses with patients include topical retinol/retinoids, which she said provide “low clinical response”; microneedling, which provides “marked” clinical response; and nonablative laser treatment, which provides “good” clinical response.
Considering particular patient characteristics, including budget, Dr. Alster said, “For those on a limited budget, I would propose daily use of a topical retinol, despite the low clinical effect. Many retinol-containing products are available over the counter. Prescription-strength retinoic acid tends to be pricey, often costing as much as in-office treatments.” Medical microneedling (not the cosmetic “roller” microneedling performed by aestheticians), she added, “gives the best results for the money and produces clinical results that mirror those achieved with lasers.”
Dr. Wang agreed that even recommending less expensive and less efficacious options such as over-the-counter creams can help alleviate patients’ concerns. “It shows that you are being holistic – not just caring for medical issues around pregnancy, but that you also take the emotional/psychological concerns of pregnant individuals and new parents seriously and that you recognize the impact of skin problems on quality of life. In the end, recommending something – in other words, providing some options, like creams or other therapies, for instance – is still, in my opinion, better than not recommending anything.”
Dr. Wang is involved with a study that is currently enrolling patients and that is evaluating the formation of early SG, which includes performing skin biopsies as soon as lesions appear.
The study had no funding. The study authors and Dr. Alster disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Does the use of frankincense make sense in dermatology?
The Boswellia serrata exudate or gum (known in India as “guggulu”) that forms an aromatic resin traditionally used as incense – and known as frankincense (especially when retrieved from Boswellia species found in Eritrea and Somalia but also from the Indian variety) – has been considered for thousands of years to possess therapeutic properties. It is used in Ayurvedic medicine, as well as in traditional medicine in China and the Middle East, particularly for its anti-inflammatory effects to treat chronic conditions.1-8 In fact, such essential oils have been used since 2800 BC to treat various inflammatory conditions, including skin sores and wounds, as well as in perfumes and incense.2,9 In the West, use of frankincense dates back to thousands of years as well, more often found in the form of incense for religious and cultural ceremonies.7 Over the past 2 decades, .3 This column focuses on some of the emerging data on this ancient botanical agent.
Chemical constituents
Terpenoids and essential oils are the primary components of frankincense and are known to impart anti-inflammatory and anticancer activity. The same is true for myrrh, which has been combined with frankincense in traditional Chinese medicine as a single medication for millennia, with the two acting synergistically and considered still to be a potent combination in conferring various biological benefits.7
In 2010, in a systematic review of the anti-inflammatory and anticancer activities of Boswellia species and their chemical ingredients, Efferth and Oesch found that frankincense blocks the production of leukotrienes, cyclooxygenase (COX) 1 and 2, as well as 5-lipoxygenase; and oxidative stress. It also contributes to regulation of immune cells from the innate and acquired immune systems and exerts anticancer activity by influencing signaling transduction responsible for cell cycle arrest, as well as inhibition of proliferation, angiogenesis, invasion, and metastasis. The investigators also reported on clinical trial results that have found efficacy of frankincense and its constituents in ameliorating symptoms of psoriasis and erythematous eczema, among other disorders.3
Anti-inflammatory activity
Li et al. completed a study in 2016 to identify the active ingredients responsible for the anti-inflammatory and analgesic effects of frankincense. They found that alpha-pinene, linalool, and 1-octanol were key contributors. These constituents were noted for suppressing COX-2 overexpression in mice, as well as nociceptive stimulus-induced inflammatory infiltrates.10
Noting the increasing popularity of frankincense essential oil in skin care, despite a paucity of data, in 2017, Han et al. evaluated the biological activities of the essential oil in pre-inflamed human dermal fibroblasts using 17 key protein biomarkers. Frankincense essential oil displayed significant antiproliferative activity and suppressed collagen III, interferon gamma-induced protein 10, and intracellular adhesion molecule 1. The investigators referred to the overall encouraging potential of frankincense essential oil to exert influence over inflammation and tissue remodeling in human skin and called for additional research into its mechanisms of action and active constituents.11
Anticancer activity
The main active ingredient in frankincense, boswellic acid, has been shown to promote apoptosis, suppress matrix metalloproteinase secretion, and hinder migration in metastatic melanoma cell lines in mice.6,12
In 2019, Hakkim et al. demonstrated that frankincense essential oil yielded substantial antimelanoma activity in vitro and in vivo and ameliorated hepatotoxicity caused by acetaminophen.13
There is one case report in the literature on the use of frankincense as a treatment for skin cancer. A 56-year-old man received frankincense oil multiple times a day for 4 months to treat a nodular basal cell carcinoma on one arm (which resolved) and an infiltrative BCC on the chest (some focal residual tumor remained).6,14 Topical frankincense or boswellic acid has been given a grade D recommendation for treating skin cancer, however, because of only one level-of-evidence-5 study.6
Antimicrobial activity
In 2012, de Rapper et al. collected samples of three essential oils of frankincense (Boswellia rivae, Boswellia neglecta, and Boswellia papyrifera) and two essential oil samples of myrrh and sweet myrrh from different regions of Ethiopia to study their anti-infective properties alone and in combination. The investigators observed synergistic and additive effects, particularly between B. papyrifera and Commiphora myrrha. While noting the long history of the combined use of frankincense and myrrh essential oils since 1500 BC, the investigators highlighted their study as the first antimicrobial work to verify the effectiveness of this combination, validating the use of this combination to thwart particular pathogens.15
Just 2 years ago, Ljaljević Grbić et al. evaluated the in vitro antimicrobial potential of the liquid and vapor phases of B. carteri and C. myrrha (frankincense and myrrh, respectively) essential oils, finding that frankincense demonstrated marked capacity to act as a natural antimicrobial agent.9
Transdermal delivery
In 2017, Zhu et al. showed that frankincense and myrrh essential oils promoted the permeability of the Chinese herb Chuanxiong and may facilitate drug elimination from the epidermis via dermal capillaries by dint of improved cutaneous blood flow, thereby augmenting transdermal drug delivery.16 The same team also showed that frankincense and myrrh essential oils, by fostering permeation by enhancing drug delivery across the stratum corneum, can also alter the structure of the stratum corneum.17
Conclusion
The use of frankincense in traditional medicine has a long and impressive track record. Recent research provides reason for optimism, and further investigating the possible incorporation of this botanical agent into modern dermatologic therapies appears warranted. Clearly, however, much more research is needed.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Kimmatkar N et al. Phytomedicine. 2003 Jan;10(1):3-7.
2. Ammon HP. Wien Med Wochenschr. 2002;152(15-16):373-8.
3. Efferth T & Oesch F. Semin Cancer Biol. 2020 Feb 4;S1044-579X(20)30034-1.
4. Banno N et al. J Ethnopharmacol. 2006 Sep 19;107(2):249-53.
5. Poeckel D & Werz O. Curr Med Chem. 2006;13(28):3359-69.
6. Li JY, Kampp JT. Dermatol Surg. 2019 Jan;45(1):58-67.
7. Cao B et al. Molecules. 2019 Aug 24;24(17): 3076.
8. Mertens M et al. Flavour Fragr J. 2009;24:279-300.
9. Ljaljević Grbić M et al. J Ethnopharmacol. 2018 Jun 12;219:1-14.
10. Li XJ et al. J Ethnopharmacol. 2016 Feb 17;179:22-6.
11. Han X et al. Biochim Open. 2017 Feb 3;4:31-5.
12. Zhao W et al. Cancer Detect Prev. 2003;27:67-75.
13. Hakkim FL et al. Oncotarget. 2019 May 28;10(37):3472-90.
14. Fung K et al. OA Altern Med 2013;1:14.
15. de Rapper S et al. Lett Appl Microbiol. 2012 Apr;54(4):352-8.
16. Zhu XF et al. Zhongguo Zhong Yao Za Zhi. 2017 Feb;42(4):680-5.
17. Guan YM et al. Zhongguo Zhong Yao Za Zhi. 2017 Sep;42(17):3350-5.
The Boswellia serrata exudate or gum (known in India as “guggulu”) that forms an aromatic resin traditionally used as incense – and known as frankincense (especially when retrieved from Boswellia species found in Eritrea and Somalia but also from the Indian variety) – has been considered for thousands of years to possess therapeutic properties. It is used in Ayurvedic medicine, as well as in traditional medicine in China and the Middle East, particularly for its anti-inflammatory effects to treat chronic conditions.1-8 In fact, such essential oils have been used since 2800 BC to treat various inflammatory conditions, including skin sores and wounds, as well as in perfumes and incense.2,9 In the West, use of frankincense dates back to thousands of years as well, more often found in the form of incense for religious and cultural ceremonies.7 Over the past 2 decades, .3 This column focuses on some of the emerging data on this ancient botanical agent.
Chemical constituents
Terpenoids and essential oils are the primary components of frankincense and are known to impart anti-inflammatory and anticancer activity. The same is true for myrrh, which has been combined with frankincense in traditional Chinese medicine as a single medication for millennia, with the two acting synergistically and considered still to be a potent combination in conferring various biological benefits.7
In 2010, in a systematic review of the anti-inflammatory and anticancer activities of Boswellia species and their chemical ingredients, Efferth and Oesch found that frankincense blocks the production of leukotrienes, cyclooxygenase (COX) 1 and 2, as well as 5-lipoxygenase; and oxidative stress. It also contributes to regulation of immune cells from the innate and acquired immune systems and exerts anticancer activity by influencing signaling transduction responsible for cell cycle arrest, as well as inhibition of proliferation, angiogenesis, invasion, and metastasis. The investigators also reported on clinical trial results that have found efficacy of frankincense and its constituents in ameliorating symptoms of psoriasis and erythematous eczema, among other disorders.3
Anti-inflammatory activity
Li et al. completed a study in 2016 to identify the active ingredients responsible for the anti-inflammatory and analgesic effects of frankincense. They found that alpha-pinene, linalool, and 1-octanol were key contributors. These constituents were noted for suppressing COX-2 overexpression in mice, as well as nociceptive stimulus-induced inflammatory infiltrates.10
Noting the increasing popularity of frankincense essential oil in skin care, despite a paucity of data, in 2017, Han et al. evaluated the biological activities of the essential oil in pre-inflamed human dermal fibroblasts using 17 key protein biomarkers. Frankincense essential oil displayed significant antiproliferative activity and suppressed collagen III, interferon gamma-induced protein 10, and intracellular adhesion molecule 1. The investigators referred to the overall encouraging potential of frankincense essential oil to exert influence over inflammation and tissue remodeling in human skin and called for additional research into its mechanisms of action and active constituents.11
Anticancer activity
The main active ingredient in frankincense, boswellic acid, has been shown to promote apoptosis, suppress matrix metalloproteinase secretion, and hinder migration in metastatic melanoma cell lines in mice.6,12
In 2019, Hakkim et al. demonstrated that frankincense essential oil yielded substantial antimelanoma activity in vitro and in vivo and ameliorated hepatotoxicity caused by acetaminophen.13
There is one case report in the literature on the use of frankincense as a treatment for skin cancer. A 56-year-old man received frankincense oil multiple times a day for 4 months to treat a nodular basal cell carcinoma on one arm (which resolved) and an infiltrative BCC on the chest (some focal residual tumor remained).6,14 Topical frankincense or boswellic acid has been given a grade D recommendation for treating skin cancer, however, because of only one level-of-evidence-5 study.6
Antimicrobial activity
In 2012, de Rapper et al. collected samples of three essential oils of frankincense (Boswellia rivae, Boswellia neglecta, and Boswellia papyrifera) and two essential oil samples of myrrh and sweet myrrh from different regions of Ethiopia to study their anti-infective properties alone and in combination. The investigators observed synergistic and additive effects, particularly between B. papyrifera and Commiphora myrrha. While noting the long history of the combined use of frankincense and myrrh essential oils since 1500 BC, the investigators highlighted their study as the first antimicrobial work to verify the effectiveness of this combination, validating the use of this combination to thwart particular pathogens.15
Just 2 years ago, Ljaljević Grbić et al. evaluated the in vitro antimicrobial potential of the liquid and vapor phases of B. carteri and C. myrrha (frankincense and myrrh, respectively) essential oils, finding that frankincense demonstrated marked capacity to act as a natural antimicrobial agent.9
Transdermal delivery
In 2017, Zhu et al. showed that frankincense and myrrh essential oils promoted the permeability of the Chinese herb Chuanxiong and may facilitate drug elimination from the epidermis via dermal capillaries by dint of improved cutaneous blood flow, thereby augmenting transdermal drug delivery.16 The same team also showed that frankincense and myrrh essential oils, by fostering permeation by enhancing drug delivery across the stratum corneum, can also alter the structure of the stratum corneum.17
Conclusion
The use of frankincense in traditional medicine has a long and impressive track record. Recent research provides reason for optimism, and further investigating the possible incorporation of this botanical agent into modern dermatologic therapies appears warranted. Clearly, however, much more research is needed.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Kimmatkar N et al. Phytomedicine. 2003 Jan;10(1):3-7.
2. Ammon HP. Wien Med Wochenschr. 2002;152(15-16):373-8.
3. Efferth T & Oesch F. Semin Cancer Biol. 2020 Feb 4;S1044-579X(20)30034-1.
4. Banno N et al. J Ethnopharmacol. 2006 Sep 19;107(2):249-53.
5. Poeckel D & Werz O. Curr Med Chem. 2006;13(28):3359-69.
6. Li JY, Kampp JT. Dermatol Surg. 2019 Jan;45(1):58-67.
7. Cao B et al. Molecules. 2019 Aug 24;24(17): 3076.
8. Mertens M et al. Flavour Fragr J. 2009;24:279-300.
9. Ljaljević Grbić M et al. J Ethnopharmacol. 2018 Jun 12;219:1-14.
10. Li XJ et al. J Ethnopharmacol. 2016 Feb 17;179:22-6.
11. Han X et al. Biochim Open. 2017 Feb 3;4:31-5.
12. Zhao W et al. Cancer Detect Prev. 2003;27:67-75.
13. Hakkim FL et al. Oncotarget. 2019 May 28;10(37):3472-90.
14. Fung K et al. OA Altern Med 2013;1:14.
15. de Rapper S et al. Lett Appl Microbiol. 2012 Apr;54(4):352-8.
16. Zhu XF et al. Zhongguo Zhong Yao Za Zhi. 2017 Feb;42(4):680-5.
17. Guan YM et al. Zhongguo Zhong Yao Za Zhi. 2017 Sep;42(17):3350-5.
The Boswellia serrata exudate or gum (known in India as “guggulu”) that forms an aromatic resin traditionally used as incense – and known as frankincense (especially when retrieved from Boswellia species found in Eritrea and Somalia but also from the Indian variety) – has been considered for thousands of years to possess therapeutic properties. It is used in Ayurvedic medicine, as well as in traditional medicine in China and the Middle East, particularly for its anti-inflammatory effects to treat chronic conditions.1-8 In fact, such essential oils have been used since 2800 BC to treat various inflammatory conditions, including skin sores and wounds, as well as in perfumes and incense.2,9 In the West, use of frankincense dates back to thousands of years as well, more often found in the form of incense for religious and cultural ceremonies.7 Over the past 2 decades, .3 This column focuses on some of the emerging data on this ancient botanical agent.
Chemical constituents
Terpenoids and essential oils are the primary components of frankincense and are known to impart anti-inflammatory and anticancer activity. The same is true for myrrh, which has been combined with frankincense in traditional Chinese medicine as a single medication for millennia, with the two acting synergistically and considered still to be a potent combination in conferring various biological benefits.7
In 2010, in a systematic review of the anti-inflammatory and anticancer activities of Boswellia species and their chemical ingredients, Efferth and Oesch found that frankincense blocks the production of leukotrienes, cyclooxygenase (COX) 1 and 2, as well as 5-lipoxygenase; and oxidative stress. It also contributes to regulation of immune cells from the innate and acquired immune systems and exerts anticancer activity by influencing signaling transduction responsible for cell cycle arrest, as well as inhibition of proliferation, angiogenesis, invasion, and metastasis. The investigators also reported on clinical trial results that have found efficacy of frankincense and its constituents in ameliorating symptoms of psoriasis and erythematous eczema, among other disorders.3
Anti-inflammatory activity
Li et al. completed a study in 2016 to identify the active ingredients responsible for the anti-inflammatory and analgesic effects of frankincense. They found that alpha-pinene, linalool, and 1-octanol were key contributors. These constituents were noted for suppressing COX-2 overexpression in mice, as well as nociceptive stimulus-induced inflammatory infiltrates.10
Noting the increasing popularity of frankincense essential oil in skin care, despite a paucity of data, in 2017, Han et al. evaluated the biological activities of the essential oil in pre-inflamed human dermal fibroblasts using 17 key protein biomarkers. Frankincense essential oil displayed significant antiproliferative activity and suppressed collagen III, interferon gamma-induced protein 10, and intracellular adhesion molecule 1. The investigators referred to the overall encouraging potential of frankincense essential oil to exert influence over inflammation and tissue remodeling in human skin and called for additional research into its mechanisms of action and active constituents.11
Anticancer activity
The main active ingredient in frankincense, boswellic acid, has been shown to promote apoptosis, suppress matrix metalloproteinase secretion, and hinder migration in metastatic melanoma cell lines in mice.6,12
In 2019, Hakkim et al. demonstrated that frankincense essential oil yielded substantial antimelanoma activity in vitro and in vivo and ameliorated hepatotoxicity caused by acetaminophen.13
There is one case report in the literature on the use of frankincense as a treatment for skin cancer. A 56-year-old man received frankincense oil multiple times a day for 4 months to treat a nodular basal cell carcinoma on one arm (which resolved) and an infiltrative BCC on the chest (some focal residual tumor remained).6,14 Topical frankincense or boswellic acid has been given a grade D recommendation for treating skin cancer, however, because of only one level-of-evidence-5 study.6
Antimicrobial activity
In 2012, de Rapper et al. collected samples of three essential oils of frankincense (Boswellia rivae, Boswellia neglecta, and Boswellia papyrifera) and two essential oil samples of myrrh and sweet myrrh from different regions of Ethiopia to study their anti-infective properties alone and in combination. The investigators observed synergistic and additive effects, particularly between B. papyrifera and Commiphora myrrha. While noting the long history of the combined use of frankincense and myrrh essential oils since 1500 BC, the investigators highlighted their study as the first antimicrobial work to verify the effectiveness of this combination, validating the use of this combination to thwart particular pathogens.15
Just 2 years ago, Ljaljević Grbić et al. evaluated the in vitro antimicrobial potential of the liquid and vapor phases of B. carteri and C. myrrha (frankincense and myrrh, respectively) essential oils, finding that frankincense demonstrated marked capacity to act as a natural antimicrobial agent.9
Transdermal delivery
In 2017, Zhu et al. showed that frankincense and myrrh essential oils promoted the permeability of the Chinese herb Chuanxiong and may facilitate drug elimination from the epidermis via dermal capillaries by dint of improved cutaneous blood flow, thereby augmenting transdermal drug delivery.16 The same team also showed that frankincense and myrrh essential oils, by fostering permeation by enhancing drug delivery across the stratum corneum, can also alter the structure of the stratum corneum.17
Conclusion
The use of frankincense in traditional medicine has a long and impressive track record. Recent research provides reason for optimism, and further investigating the possible incorporation of this botanical agent into modern dermatologic therapies appears warranted. Clearly, however, much more research is needed.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Kimmatkar N et al. Phytomedicine. 2003 Jan;10(1):3-7.
2. Ammon HP. Wien Med Wochenschr. 2002;152(15-16):373-8.
3. Efferth T & Oesch F. Semin Cancer Biol. 2020 Feb 4;S1044-579X(20)30034-1.
4. Banno N et al. J Ethnopharmacol. 2006 Sep 19;107(2):249-53.
5. Poeckel D & Werz O. Curr Med Chem. 2006;13(28):3359-69.
6. Li JY, Kampp JT. Dermatol Surg. 2019 Jan;45(1):58-67.
7. Cao B et al. Molecules. 2019 Aug 24;24(17): 3076.
8. Mertens M et al. Flavour Fragr J. 2009;24:279-300.
9. Ljaljević Grbić M et al. J Ethnopharmacol. 2018 Jun 12;219:1-14.
10. Li XJ et al. J Ethnopharmacol. 2016 Feb 17;179:22-6.
11. Han X et al. Biochim Open. 2017 Feb 3;4:31-5.
12. Zhao W et al. Cancer Detect Prev. 2003;27:67-75.
13. Hakkim FL et al. Oncotarget. 2019 May 28;10(37):3472-90.
14. Fung K et al. OA Altern Med 2013;1:14.
15. de Rapper S et al. Lett Appl Microbiol. 2012 Apr;54(4):352-8.
16. Zhu XF et al. Zhongguo Zhong Yao Za Zhi. 2017 Feb;42(4):680-5.
17. Guan YM et al. Zhongguo Zhong Yao Za Zhi. 2017 Sep;42(17):3350-5.
What are the legal risks of practicing laser cutaneous surgery?
The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.
“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”
Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.
Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.
In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”
The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”
In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.
On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.
Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”
The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).
“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”
Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”
In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”
Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.
“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”
Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.
Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.
In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”
The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”
In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.
On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.
Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”
The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).
“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”
Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”
In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”
Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
The physician-patient relationship is a key factor in preventing litigation following cutaneous laser surgery, according to Mathew M. Avram, MD, JD.
“Numerous studies indicate that good communication and rapport are the most important means to avoid a lawsuit,” Dr. Avram, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said during a virtual course on laser and aesthetic skin therapy. “It is helpful to say that the outcome was not optimal or what you were anticipating. Communicate your plan [for the complication] clearly and honestly to your patient. The patient may not understand the severity of the complication. If they don’t, they will either leave it alone or they will go elsewhere and may receive poor care.” He added that in New England, “we have some stoic patients who may say ‘I don’t want to bother the doctor’ or ‘It’s my fault for having the procedure done.’ ”
Establishing effective communication with patients from the outset is good practice, he continued, because 75% of physicians in low-risk specialties will face a malpractice claim by age 65. Nearly a decade ago Dr. Avram, H. Ray Jalian, MD, and Chris Jalian, JD, published results from a national legal database analysis identifying common errors and risk factors for litigation in cutaneous surgery. Their search yielded 1,807 documents with 174 unique legal claims involving injury from a cutaneous laser treatment, from 1985 to 2012. The most common litigated procedures were laser hair removal, rejuvenation (mostly related to intense pulsed-light treatments), and laser treatment of leg veins, while the most common injuries sustained were burns, scars, and pigmentary changes. The most common causes of legal action were lack of informed consent and fraud.
Among the 120 cases with public decisions, cases favored the plaintiff 51% of the time. “That’s unusual,” said Dr. Avram, president of American Society for Dermatologic Surgery. “Usually, physicians do better, but I think the fact that they’re cosmetic cases probably shades things a little bit.” The median monetary award was $350,000 and ranged from $5,000 to $2,145,000. The two largest judgments were for improper use of topical anesthesia that led to deaths of patients in laser hair removal cases.
In a separate analysis, the same authors searched an online national database to identify the incidence of medical professional liability claims resulting from cutaneous laser surgery performed by nonphysician operators (NPOs) from 1999 to 2012. Among the 175 cases identified, 43% involved an NPO. “In fact, the cases involving NPOs exploded over a 4-year period; they grew from 36% in 2008 of cases to 78% in 2011,” Dr. Avram said. “This was even more true for laser hair removal.”
The practice setting turned out to be a factor. Only 23% of NPO litigation involving laser procedures arose in medical office settings, while 77% of cases involving NPOs were performed outside of traditional medical settings such as in salons and medical spas – mostly for laser hair removal. “We updated this information by examining the setting for nonphysician operator litigation between 2012 and 2017 and found that 66% of cases involving NPOs were performed outside of a traditional medical setting, while 34% of NPO litigation arose in medical office settings,” Dr. Avram said during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. “That’s close to a 2 to 1 ratio.”
In an analysis of medical professional liability claims involving Mohs surgery from 1989 to 2011, 26 of the 42 cases identified involved a primary defendant who was not a Mohs surgeon. In the 26 cases, the most common reasons for lawsuits were failure or delay of diagnosis of a skin cancer, cosmetic outcome issues, lack of informed consent, and delay or failure to refer to a Mohs surgeon. Of the cases that involved Mohs surgeons, the most common causes were lack of proper informed consent and cosmetic outcome issues, but “these cases were overwhelmingly decided in favor of the surgeons,” said Dr. Avram, one of the study authors.
On a related note, Dr. Avram underscored the importance of biopsy-site photography, “because patients and physicians misidentify biopsy sites too commonly,” he said. In a single-center study of 34 biopsy sites of cutaneous head and neck malignancies, patients misidentified the biopsy site 4-7 weeks out in 29% of the cases. Blinded dermatologists and the patient misidentified the biopsy site in 12% of the cases. “Good biopsy site photography should be mandatory in your practice,” he advised.
Clinicians can avoid cutaneous laser surgery complications only by not treating patients. “Complications and side effects are inevitable; you need to know your limits,” he said. “Even in skilled hands, if you treat enough patients, you will encounter challenging side effects. Do not perform a procedure that might produce a side effect that you cannot recognize and treat.”
The best way to avoid complications is to trust your eyes – not the laser – since the same device made by the same manufacturer may produce highly different outputs at the same setting (see J Am Acad Dermatol. 2016;74[5]:807-19).
“Moreover, lasers can produce much different energies after they have been serviced,” Dr. Avram said. “Do not memorize settings. Do not blindly replicate recommended settings from a colleague or a device manufacturer,” he advised. “Some devices are not externally calibrated. Therefore, the settings on one device may not translate the same way to yours. Often, device manufacturers underplay the settings. Safe and unsafe laser endpoints and close observation are the best means to avoiding clinical complications. That means you follow clinical endpoints, not fluences. The key clinical finding is the endpoint, not the energy setting.”
Temporary and expected side effects include erythema, edema, and purpura. “With these it’s just handholding and unlikely to lead to any legal consequences,” he continued. “With temporary hyperpigmentation that can occur with laser hair removal, time is one your side, because typically this will resolve before any litigation progresses. Permanent side effects from lasers and light sources and injectables are a different issue, things like permanent hypopigmentation, depigmentation, and scarring. These are most likely to produce liability.”
In Dr. Avram’s opinion, complications are best handled with widespread communication. “There is a temptation to avoid a patient with a poor outcome or side effect,” he said. “This is bad medicine and rightfully angers your patient and increases the risk of a lawsuit. [Resist] the temptation to avoid showing a poor outcome to a colleague. Many complications can be significantly improved or cleared with timely and appropriate interventions. You should always document your efforts.”
Dr. Avram disclosed that he has received consulting fees from Allergan and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
FROM A LASER & AESTHETIC SKIN THERAPY COURSE