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CD1a and cosmetic-related contact dermatitis
As industries develop more chemical extraction techniques for synthetic or purified botanical ingredients to include in cosmetic and personal care products, the incidence of contact dermatitis is rising. Contact dermatitis (irritant or allergic) is the most common occupational skin disease, with current lifetime incidence exceeding 50%. For allergic contact dermatitis, type IV hypersensitivity (or delayed-type hypersensitivity) is thought to be the immunologic mediated pathway in which a T cell–mediated response occurs approximately 72 hours after exposure to the contact allergen. Diagnosis currently is predominately made clinically, after identifying the potential allergen or via patch testing. Treatment typically involves topical steroids or anti-inflammatories should a rash occur, and avoidance of the identified allergen.
In delayed-type hypersensitivity, most T-cell receptors recognize a peptide antigen bound to major histocompatibility complex (MHC) I or MHC II proteins, which stimulates a subsequent inflammatory immune response. However, in a recently published study, the authors wrote that “most known contact allergens are nonpeptidic small molecules, cations, or metals that are typically delivered to skin as drugs, oils, cosmetics, skin creams, or fragrances.” The chemical nature and structure of contact allergens “does not match the chemical structures of most antigens commonly recognized within the TCR-peptide-MHC axis,” they added. Thus, the mechanism by which nonpeptide molecules found in cosmetics cause a T cell–mediated hypersensitivity is poorly understood.
In that study, investigators from Brigham and Women’s Hospital, Boston; Columbia University, New York; and Monash University, Melbourne, looked at whether a protein found in immune cells – CD1a – could be involved in these allergic reactions. In a press release describing the results, cosenior author D. Branch Moody, MD, a principal investigator and physician in Brigham and Women’s division of rheumatology, inflammation, and immunity, noted that they “questioned the prevailing paradigm that T cell–mediated allergic reaction is only triggered when T cells respond to proteins or peptide antigens,” and found “a mechanism through which fragrance can initiate a T-cell response through a protein called CD1a.”
In their study, CD1a was identified as the and personal care products. Specifically, balsam of Peru (a tree oil commonly found in cosmetics and toothpaste), benzyl benzoate, benzyl cinnamate, and farnesol (often present in “fragrance”) after positive patch tests were found to elicit a CD1a-mediated immune response. Their findings suggest that, for these hydrophobic contact allergens, in forming CD1a-farnesol (or other) complexes, displacement of self-lipids normally bound to CD1a occurs, exposing T cell–stimulatory surface regions of CD1a that are normally hidden, thereby eliciting T cell–mediated hypersensitivity reactions.
The authors note that having a better understanding of how these ingredients elicit an immune response on a molecular level can help us potentially identify other molecules that can potentially block this response in humans, thereby treating or potentially mitigating allergic skin disease from these ingredients.
Dr. Wesley and Dr. Talakoub 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.
Resource
Nicolai S et al. Sci Immunol. 2020 Jan 3. doi: 10.1126/sciimmunol.aax5430.
As industries develop more chemical extraction techniques for synthetic or purified botanical ingredients to include in cosmetic and personal care products, the incidence of contact dermatitis is rising. Contact dermatitis (irritant or allergic) is the most common occupational skin disease, with current lifetime incidence exceeding 50%. For allergic contact dermatitis, type IV hypersensitivity (or delayed-type hypersensitivity) is thought to be the immunologic mediated pathway in which a T cell–mediated response occurs approximately 72 hours after exposure to the contact allergen. Diagnosis currently is predominately made clinically, after identifying the potential allergen or via patch testing. Treatment typically involves topical steroids or anti-inflammatories should a rash occur, and avoidance of the identified allergen.
In delayed-type hypersensitivity, most T-cell receptors recognize a peptide antigen bound to major histocompatibility complex (MHC) I or MHC II proteins, which stimulates a subsequent inflammatory immune response. However, in a recently published study, the authors wrote that “most known contact allergens are nonpeptidic small molecules, cations, or metals that are typically delivered to skin as drugs, oils, cosmetics, skin creams, or fragrances.” The chemical nature and structure of contact allergens “does not match the chemical structures of most antigens commonly recognized within the TCR-peptide-MHC axis,” they added. Thus, the mechanism by which nonpeptide molecules found in cosmetics cause a T cell–mediated hypersensitivity is poorly understood.
In that study, investigators from Brigham and Women’s Hospital, Boston; Columbia University, New York; and Monash University, Melbourne, looked at whether a protein found in immune cells – CD1a – could be involved in these allergic reactions. In a press release describing the results, cosenior author D. Branch Moody, MD, a principal investigator and physician in Brigham and Women’s division of rheumatology, inflammation, and immunity, noted that they “questioned the prevailing paradigm that T cell–mediated allergic reaction is only triggered when T cells respond to proteins or peptide antigens,” and found “a mechanism through which fragrance can initiate a T-cell response through a protein called CD1a.”
In their study, CD1a was identified as the and personal care products. Specifically, balsam of Peru (a tree oil commonly found in cosmetics and toothpaste), benzyl benzoate, benzyl cinnamate, and farnesol (often present in “fragrance”) after positive patch tests were found to elicit a CD1a-mediated immune response. Their findings suggest that, for these hydrophobic contact allergens, in forming CD1a-farnesol (or other) complexes, displacement of self-lipids normally bound to CD1a occurs, exposing T cell–stimulatory surface regions of CD1a that are normally hidden, thereby eliciting T cell–mediated hypersensitivity reactions.
The authors note that having a better understanding of how these ingredients elicit an immune response on a molecular level can help us potentially identify other molecules that can potentially block this response in humans, thereby treating or potentially mitigating allergic skin disease from these ingredients.
Dr. Wesley and Dr. Talakoub 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.
Resource
Nicolai S et al. Sci Immunol. 2020 Jan 3. doi: 10.1126/sciimmunol.aax5430.
As industries develop more chemical extraction techniques for synthetic or purified botanical ingredients to include in cosmetic and personal care products, the incidence of contact dermatitis is rising. Contact dermatitis (irritant or allergic) is the most common occupational skin disease, with current lifetime incidence exceeding 50%. For allergic contact dermatitis, type IV hypersensitivity (or delayed-type hypersensitivity) is thought to be the immunologic mediated pathway in which a T cell–mediated response occurs approximately 72 hours after exposure to the contact allergen. Diagnosis currently is predominately made clinically, after identifying the potential allergen or via patch testing. Treatment typically involves topical steroids or anti-inflammatories should a rash occur, and avoidance of the identified allergen.
In delayed-type hypersensitivity, most T-cell receptors recognize a peptide antigen bound to major histocompatibility complex (MHC) I or MHC II proteins, which stimulates a subsequent inflammatory immune response. However, in a recently published study, the authors wrote that “most known contact allergens are nonpeptidic small molecules, cations, or metals that are typically delivered to skin as drugs, oils, cosmetics, skin creams, or fragrances.” The chemical nature and structure of contact allergens “does not match the chemical structures of most antigens commonly recognized within the TCR-peptide-MHC axis,” they added. Thus, the mechanism by which nonpeptide molecules found in cosmetics cause a T cell–mediated hypersensitivity is poorly understood.
In that study, investigators from Brigham and Women’s Hospital, Boston; Columbia University, New York; and Monash University, Melbourne, looked at whether a protein found in immune cells – CD1a – could be involved in these allergic reactions. In a press release describing the results, cosenior author D. Branch Moody, MD, a principal investigator and physician in Brigham and Women’s division of rheumatology, inflammation, and immunity, noted that they “questioned the prevailing paradigm that T cell–mediated allergic reaction is only triggered when T cells respond to proteins or peptide antigens,” and found “a mechanism through which fragrance can initiate a T-cell response through a protein called CD1a.”
In their study, CD1a was identified as the and personal care products. Specifically, balsam of Peru (a tree oil commonly found in cosmetics and toothpaste), benzyl benzoate, benzyl cinnamate, and farnesol (often present in “fragrance”) after positive patch tests were found to elicit a CD1a-mediated immune response. Their findings suggest that, for these hydrophobic contact allergens, in forming CD1a-farnesol (or other) complexes, displacement of self-lipids normally bound to CD1a occurs, exposing T cell–stimulatory surface regions of CD1a that are normally hidden, thereby eliciting T cell–mediated hypersensitivity reactions.
The authors note that having a better understanding of how these ingredients elicit an immune response on a molecular level can help us potentially identify other molecules that can potentially block this response in humans, thereby treating or potentially mitigating allergic skin disease from these ingredients.
Dr. Wesley and Dr. Talakoub 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.
Resource
Nicolai S et al. Sci Immunol. 2020 Jan 3. doi: 10.1126/sciimmunol.aax5430.
Pyrrolidone carboxylic acid may be a key cutaneous biomarker
Pyrrolidone carboxylic acid (PCA), the primary constituent of the natural moisturizing factor (NMF),1 including its derivatives – such as simple2 and novel3 esters as well as sugar complexes4 – is the subject of great interest and research regarding its capacity to moisturize the stratum corneum via topical application.
Creams and lotions containing the sodium salt of PCA are widely reported to aid in hydrating the skin and ameliorating dry flaky skin conditions.5,6 In addition, the zinc salt of L-pyrrolidone carboxylate is a longtime cosmetic ingredient due to antimicrobial and astringent qualities. This column briefly addresses the role of PCA in skin health.7
Dry skin
In a comprehensive literature review from 1981, Clar and Fourtanier reported conclusive evidence that PCA acts as a hydrating agent and that all the cosmetic formulations with a minimum of 2% PCA and PCA salt that they tested in their own 8-year study enhanced dry skin in short- and long-term conditions given suitable vehicles (no aqueous solutions).6
In a 2014 clinical study of 64 healthy white women with either normal or cosmetic dry skin, Feng et al. noted that tape stripped samples of stratum corneum revealed significantly lower ratios of free amino acids to protein and PCA to protein. This was associated with decreased hydration levels compared with normal skin. The investigators concluded that lower NMF levels across the depth of the stratum corneum and reduced cohesivity characterize cosmetic dry skin and that these clinical endpoints merit attention in evaluating the usefulness of treatments for dry skin.8
In 2016, Wei et al. reported on their assessment of the barrier function, hydration, and dryness of the lower leg skin of 25 female patients during the winter and then in the subsequent summer. They found that PCA levels were significantly greater during the summer, as were keratins. Hydration was also higher during the summer, while transepidermal water loss and visual dryness grades were substantially lower.9
Atopic dermatitis
A 2014 clinical study by Brandt et al. in patients with skin prone to developing atopic dermatitis (AD) revealed that a body wash composed of the filaggrin metabolites arginine and PCA was well tolerated and diminished pruritus. Patients reported liking the product and suggested that it improved their quality of life.10
Later that year, Jung et al. characterized the relationship of PCA levels, and other factors, with the clinical severity of AD. Specifically, in a study of 73 subjects (21 with mild AD, 21 with moderate to severe AD, 13 with X-linked ichthyosis as a negative control for filaggrin gene mutation, and 18 healthy controls), the investigators assessed transepidermal water loss, stratum corneum hydration, and skin surface pH. They found that PCA levels and caspase-14 were lower in inflammatory lesions compared with nonlesional skin in subjects with AD. These levels also were associated with clinical AD severity as measured by eczema area and severity index scores as well as skin barrier function.11
PCA as a biomarker
In 2009, Kezic et al. determined that the use of tape stripping to cull PCA in the stratum corneum was effective in revealing that PCA concentration in the outermost skin layer is a viable biomarker of filaggrin genotype.12
Raj et al. conducted an interesting study in 2016 in which they set out to describe the various markers for total NMF levels and link them to the activities of plasmin and corneocyte maturation in the photoexposed cheek and photoprotected postauricular regions of healthy white, black African, and albino African women in South Africa. PCA levels were highest among the albino African group, followed by black African and then white participants. The investigators also found that bleomycin hydrolase was linked to PCA synthesis, as suggested by higher bleomycin levels in albino African participants. In this group, corneocyte maturation was also observed to be impeded.13
The next year, the same team studied stratum corneum physiology and biochemistry of the cheeks in 48 white women with sensitive skin. The goal was to ascertain the connections between bleomycin hydrolase and calpain-1, PCA levels, corneocyte maturation, and transglutaminase and plasmin activities. Capsaicin sensitivity was observed in 52% of subjects, with PCA levels and bleomycin hydrolase activity found to be lower in the capsaicin-sensitive panel and correlated in subjects not sensitive to capsaicin. The researchers concluded that reduced levels of PCA, bleomycin hydrolase, and transglutaminase combined with a larger volume of immature corneocytes suggest comparatively poor stratum corneum maturation in individuals with sensitive skin.14
Other uses
In 2012, Takino et al. used cultured normal human dermal fibroblasts to show that zinc l-pyrrolidone carboxylate blocked UVA induction of activator protein-1, diminished matrix metalloproteinase-1 synthesis, and spurred type I collagen production. The researchers suggested that such results suggest the potential of zinc PCA for further investigation as an agent to combat photoaging.7
Conclusion
. Recent research suggests that it may serve as an important biomarker of filaggrin, NMF levels, and skin hydration. In addition, new data point to its usefulness as a gauge for ADs. More investigations are necessary to ascertain the feasibility of adjusting PCA levels through topical administration and what effects topically applied PCA may have on various skin parameters.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks, “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), as well as a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].
References
1. Björklund S et al. Soft Matter. 2014 Jul 7;10(25):4535-46.
2. Hall KJ, Hill JC. J Soc Cosmet Chem. 1986;37(6):397-407.
3. Tezuka T et al. Dermatology. 1994;188(1):21-4.
4. Kwoya Hakko Kogyo Co. Pyrrolidone carboxylic acid esters containing composition used to prevent loss of moisture from the skin. Patent JA 48 82 046 (1982).
5. Org Santerre. l-pyrrolidone carboxylic acid-sugar compounds as rehydrating ingredients in cosmetics. Patent Fr 2 277 823 (1977).
6. Clar EJ, Fourtanier A. Int J Cosmet Sci. 1981 Jun;3(3):101-13.
7. Takino Y et al. Int J Cosmet Sci. 2012 Feb;34(1):23-8.
8. Feng L et al. Int J Cosmet Sci. 2014 Jun;36(3):231-8.
9. Wei KS et al. J Cosmet Sci. 2016 May-Jun;67(3):185-203.
10. Brandt S et al. J Drugs Dermatol. 2014 Sep;13(9):1108-11.
11. Jung M et al. J Dermatol Sci. 2014 Dec;76(3):231-9.
12. Kezic S et al. Br J Dermatol. 2009 Nov;161(5):1098-104.
13. Raj N et al. Int J Cosmet Sci. 2016 Dec;38(6):567-75.
14. Raj N et al. Int J Cosmet Sci. 2017 Feb;39(1):2-10.
Pyrrolidone carboxylic acid (PCA), the primary constituent of the natural moisturizing factor (NMF),1 including its derivatives – such as simple2 and novel3 esters as well as sugar complexes4 – is the subject of great interest and research regarding its capacity to moisturize the stratum corneum via topical application.
Creams and lotions containing the sodium salt of PCA are widely reported to aid in hydrating the skin and ameliorating dry flaky skin conditions.5,6 In addition, the zinc salt of L-pyrrolidone carboxylate is a longtime cosmetic ingredient due to antimicrobial and astringent qualities. This column briefly addresses the role of PCA in skin health.7
Dry skin
In a comprehensive literature review from 1981, Clar and Fourtanier reported conclusive evidence that PCA acts as a hydrating agent and that all the cosmetic formulations with a minimum of 2% PCA and PCA salt that they tested in their own 8-year study enhanced dry skin in short- and long-term conditions given suitable vehicles (no aqueous solutions).6
In a 2014 clinical study of 64 healthy white women with either normal or cosmetic dry skin, Feng et al. noted that tape stripped samples of stratum corneum revealed significantly lower ratios of free amino acids to protein and PCA to protein. This was associated with decreased hydration levels compared with normal skin. The investigators concluded that lower NMF levels across the depth of the stratum corneum and reduced cohesivity characterize cosmetic dry skin and that these clinical endpoints merit attention in evaluating the usefulness of treatments for dry skin.8
In 2016, Wei et al. reported on their assessment of the barrier function, hydration, and dryness of the lower leg skin of 25 female patients during the winter and then in the subsequent summer. They found that PCA levels were significantly greater during the summer, as were keratins. Hydration was also higher during the summer, while transepidermal water loss and visual dryness grades were substantially lower.9
Atopic dermatitis
A 2014 clinical study by Brandt et al. in patients with skin prone to developing atopic dermatitis (AD) revealed that a body wash composed of the filaggrin metabolites arginine and PCA was well tolerated and diminished pruritus. Patients reported liking the product and suggested that it improved their quality of life.10
Later that year, Jung et al. characterized the relationship of PCA levels, and other factors, with the clinical severity of AD. Specifically, in a study of 73 subjects (21 with mild AD, 21 with moderate to severe AD, 13 with X-linked ichthyosis as a negative control for filaggrin gene mutation, and 18 healthy controls), the investigators assessed transepidermal water loss, stratum corneum hydration, and skin surface pH. They found that PCA levels and caspase-14 were lower in inflammatory lesions compared with nonlesional skin in subjects with AD. These levels also were associated with clinical AD severity as measured by eczema area and severity index scores as well as skin barrier function.11
PCA as a biomarker
In 2009, Kezic et al. determined that the use of tape stripping to cull PCA in the stratum corneum was effective in revealing that PCA concentration in the outermost skin layer is a viable biomarker of filaggrin genotype.12
Raj et al. conducted an interesting study in 2016 in which they set out to describe the various markers for total NMF levels and link them to the activities of plasmin and corneocyte maturation in the photoexposed cheek and photoprotected postauricular regions of healthy white, black African, and albino African women in South Africa. PCA levels were highest among the albino African group, followed by black African and then white participants. The investigators also found that bleomycin hydrolase was linked to PCA synthesis, as suggested by higher bleomycin levels in albino African participants. In this group, corneocyte maturation was also observed to be impeded.13
The next year, the same team studied stratum corneum physiology and biochemistry of the cheeks in 48 white women with sensitive skin. The goal was to ascertain the connections between bleomycin hydrolase and calpain-1, PCA levels, corneocyte maturation, and transglutaminase and plasmin activities. Capsaicin sensitivity was observed in 52% of subjects, with PCA levels and bleomycin hydrolase activity found to be lower in the capsaicin-sensitive panel and correlated in subjects not sensitive to capsaicin. The researchers concluded that reduced levels of PCA, bleomycin hydrolase, and transglutaminase combined with a larger volume of immature corneocytes suggest comparatively poor stratum corneum maturation in individuals with sensitive skin.14
Other uses
In 2012, Takino et al. used cultured normal human dermal fibroblasts to show that zinc l-pyrrolidone carboxylate blocked UVA induction of activator protein-1, diminished matrix metalloproteinase-1 synthesis, and spurred type I collagen production. The researchers suggested that such results suggest the potential of zinc PCA for further investigation as an agent to combat photoaging.7
Conclusion
. Recent research suggests that it may serve as an important biomarker of filaggrin, NMF levels, and skin hydration. In addition, new data point to its usefulness as a gauge for ADs. More investigations are necessary to ascertain the feasibility of adjusting PCA levels through topical administration and what effects topically applied PCA may have on various skin parameters.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks, “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), as well as a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].
References
1. Björklund S et al. Soft Matter. 2014 Jul 7;10(25):4535-46.
2. Hall KJ, Hill JC. J Soc Cosmet Chem. 1986;37(6):397-407.
3. Tezuka T et al. Dermatology. 1994;188(1):21-4.
4. Kwoya Hakko Kogyo Co. Pyrrolidone carboxylic acid esters containing composition used to prevent loss of moisture from the skin. Patent JA 48 82 046 (1982).
5. Org Santerre. l-pyrrolidone carboxylic acid-sugar compounds as rehydrating ingredients in cosmetics. Patent Fr 2 277 823 (1977).
6. Clar EJ, Fourtanier A. Int J Cosmet Sci. 1981 Jun;3(3):101-13.
7. Takino Y et al. Int J Cosmet Sci. 2012 Feb;34(1):23-8.
8. Feng L et al. Int J Cosmet Sci. 2014 Jun;36(3):231-8.
9. Wei KS et al. J Cosmet Sci. 2016 May-Jun;67(3):185-203.
10. Brandt S et al. J Drugs Dermatol. 2014 Sep;13(9):1108-11.
11. Jung M et al. J Dermatol Sci. 2014 Dec;76(3):231-9.
12. Kezic S et al. Br J Dermatol. 2009 Nov;161(5):1098-104.
13. Raj N et al. Int J Cosmet Sci. 2016 Dec;38(6):567-75.
14. Raj N et al. Int J Cosmet Sci. 2017 Feb;39(1):2-10.
Pyrrolidone carboxylic acid (PCA), the primary constituent of the natural moisturizing factor (NMF),1 including its derivatives – such as simple2 and novel3 esters as well as sugar complexes4 – is the subject of great interest and research regarding its capacity to moisturize the stratum corneum via topical application.
Creams and lotions containing the sodium salt of PCA are widely reported to aid in hydrating the skin and ameliorating dry flaky skin conditions.5,6 In addition, the zinc salt of L-pyrrolidone carboxylate is a longtime cosmetic ingredient due to antimicrobial and astringent qualities. This column briefly addresses the role of PCA in skin health.7
Dry skin
In a comprehensive literature review from 1981, Clar and Fourtanier reported conclusive evidence that PCA acts as a hydrating agent and that all the cosmetic formulations with a minimum of 2% PCA and PCA salt that they tested in their own 8-year study enhanced dry skin in short- and long-term conditions given suitable vehicles (no aqueous solutions).6
In a 2014 clinical study of 64 healthy white women with either normal or cosmetic dry skin, Feng et al. noted that tape stripped samples of stratum corneum revealed significantly lower ratios of free amino acids to protein and PCA to protein. This was associated with decreased hydration levels compared with normal skin. The investigators concluded that lower NMF levels across the depth of the stratum corneum and reduced cohesivity characterize cosmetic dry skin and that these clinical endpoints merit attention in evaluating the usefulness of treatments for dry skin.8
In 2016, Wei et al. reported on their assessment of the barrier function, hydration, and dryness of the lower leg skin of 25 female patients during the winter and then in the subsequent summer. They found that PCA levels were significantly greater during the summer, as were keratins. Hydration was also higher during the summer, while transepidermal water loss and visual dryness grades were substantially lower.9
Atopic dermatitis
A 2014 clinical study by Brandt et al. in patients with skin prone to developing atopic dermatitis (AD) revealed that a body wash composed of the filaggrin metabolites arginine and PCA was well tolerated and diminished pruritus. Patients reported liking the product and suggested that it improved their quality of life.10
Later that year, Jung et al. characterized the relationship of PCA levels, and other factors, with the clinical severity of AD. Specifically, in a study of 73 subjects (21 with mild AD, 21 with moderate to severe AD, 13 with X-linked ichthyosis as a negative control for filaggrin gene mutation, and 18 healthy controls), the investigators assessed transepidermal water loss, stratum corneum hydration, and skin surface pH. They found that PCA levels and caspase-14 were lower in inflammatory lesions compared with nonlesional skin in subjects with AD. These levels also were associated with clinical AD severity as measured by eczema area and severity index scores as well as skin barrier function.11
PCA as a biomarker
In 2009, Kezic et al. determined that the use of tape stripping to cull PCA in the stratum corneum was effective in revealing that PCA concentration in the outermost skin layer is a viable biomarker of filaggrin genotype.12
Raj et al. conducted an interesting study in 2016 in which they set out to describe the various markers for total NMF levels and link them to the activities of plasmin and corneocyte maturation in the photoexposed cheek and photoprotected postauricular regions of healthy white, black African, and albino African women in South Africa. PCA levels were highest among the albino African group, followed by black African and then white participants. The investigators also found that bleomycin hydrolase was linked to PCA synthesis, as suggested by higher bleomycin levels in albino African participants. In this group, corneocyte maturation was also observed to be impeded.13
The next year, the same team studied stratum corneum physiology and biochemistry of the cheeks in 48 white women with sensitive skin. The goal was to ascertain the connections between bleomycin hydrolase and calpain-1, PCA levels, corneocyte maturation, and transglutaminase and plasmin activities. Capsaicin sensitivity was observed in 52% of subjects, with PCA levels and bleomycin hydrolase activity found to be lower in the capsaicin-sensitive panel and correlated in subjects not sensitive to capsaicin. The researchers concluded that reduced levels of PCA, bleomycin hydrolase, and transglutaminase combined with a larger volume of immature corneocytes suggest comparatively poor stratum corneum maturation in individuals with sensitive skin.14
Other uses
In 2012, Takino et al. used cultured normal human dermal fibroblasts to show that zinc l-pyrrolidone carboxylate blocked UVA induction of activator protein-1, diminished matrix metalloproteinase-1 synthesis, and spurred type I collagen production. The researchers suggested that such results suggest the potential of zinc PCA for further investigation as an agent to combat photoaging.7
Conclusion
. Recent research suggests that it may serve as an important biomarker of filaggrin, NMF levels, and skin hydration. In addition, new data point to its usefulness as a gauge for ADs. More investigations are necessary to ascertain the feasibility of adjusting PCA levels through topical administration and what effects topically applied PCA may have on various skin parameters.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks, “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), as well as a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].
References
1. Björklund S et al. Soft Matter. 2014 Jul 7;10(25):4535-46.
2. Hall KJ, Hill JC. J Soc Cosmet Chem. 1986;37(6):397-407.
3. Tezuka T et al. Dermatology. 1994;188(1):21-4.
4. Kwoya Hakko Kogyo Co. Pyrrolidone carboxylic acid esters containing composition used to prevent loss of moisture from the skin. Patent JA 48 82 046 (1982).
5. Org Santerre. l-pyrrolidone carboxylic acid-sugar compounds as rehydrating ingredients in cosmetics. Patent Fr 2 277 823 (1977).
6. Clar EJ, Fourtanier A. Int J Cosmet Sci. 1981 Jun;3(3):101-13.
7. Takino Y et al. Int J Cosmet Sci. 2012 Feb;34(1):23-8.
8. Feng L et al. Int J Cosmet Sci. 2014 Jun;36(3):231-8.
9. Wei KS et al. J Cosmet Sci. 2016 May-Jun;67(3):185-203.
10. Brandt S et al. J Drugs Dermatol. 2014 Sep;13(9):1108-11.
11. Jung M et al. J Dermatol Sci. 2014 Dec;76(3):231-9.
12. Kezic S et al. Br J Dermatol. 2009 Nov;161(5):1098-104.
13. Raj N et al. Int J Cosmet Sci. 2016 Dec;38(6):567-75.
14. Raj N et al. Int J Cosmet Sci. 2017 Feb;39(1):2-10.
Makeup is contaminated with pathogenic bacteria
Recalcitrant acne is a common, unwavering problem in dermatology practices nationwide. However, both gram positive and gram negative infections of the skin can go undiagnosed in patients with acne resistant to the armamentarium of oral and topical therapeutics. Although I often use isotretinoin in patients with cystic or recalcitrant acne, I almost always do a culture prior to initiating therapy, and more often than not, have discovered patients have gram negative and gram positive skin infections resistant to antibiotics commonly used to treat acne.
study by Bashir and Lambert published in the Journal of Applied Microbiology, 70%-90% of makeup products tested – including lipstick, lip gloss, beauty blenders, eyeliners, and mascara – were found to be contaminated with bacteria. Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli were the most common culprits, and the product with the highest contamination rates were beauty blenders (the small sponges used to apply makeup), which also had high rates of fungal contamination.
Expiration dates on cosmetic products are used to indicate the length of time a preservative in a product can control bacterial contamination. They are printed on packaging as an open jar symbol with the 3M, 6M, 9M, and 12M label for the number of months the product can be opened and used. Unfortunately and unknowingly, most consumers use products beyond the expiration date, and the most common offender is mascara.
Gram positive and gram negative skin infections should be ruled out in all cases of recalcitrant acne. A reminder to note on all culture requisitions to grow gram negatives because not all labs will grow gram negatives on a skin swab. Counseling should also be given to those patients who wear makeup, which should include techniques to clean and sanitize makeup applicators including brushes, tools, and towels. Blenders are known to be used “wet” and are not dried when washed.
It is my recommendation that blenders be a one-time-use-only tool and disposed of after EVERY application. Instructions provided in my clinic are to wash all devices and brushes once a week with hot soapy water, and blow dry with a hair dryer immediately afterward. Lipsticks, mascara wands, and lip glosses should be sanitized with alcohol once a month. Finally, all products need to be disposed of after their expiry.
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.
Resource
Basher A, Lambert P. J Appl Microbiol. 2019. doi: 10.1111/jam.14479.
Recalcitrant acne is a common, unwavering problem in dermatology practices nationwide. However, both gram positive and gram negative infections of the skin can go undiagnosed in patients with acne resistant to the armamentarium of oral and topical therapeutics. Although I often use isotretinoin in patients with cystic or recalcitrant acne, I almost always do a culture prior to initiating therapy, and more often than not, have discovered patients have gram negative and gram positive skin infections resistant to antibiotics commonly used to treat acne.
study by Bashir and Lambert published in the Journal of Applied Microbiology, 70%-90% of makeup products tested – including lipstick, lip gloss, beauty blenders, eyeliners, and mascara – were found to be contaminated with bacteria. Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli were the most common culprits, and the product with the highest contamination rates were beauty blenders (the small sponges used to apply makeup), which also had high rates of fungal contamination.
Expiration dates on cosmetic products are used to indicate the length of time a preservative in a product can control bacterial contamination. They are printed on packaging as an open jar symbol with the 3M, 6M, 9M, and 12M label for the number of months the product can be opened and used. Unfortunately and unknowingly, most consumers use products beyond the expiration date, and the most common offender is mascara.
Gram positive and gram negative skin infections should be ruled out in all cases of recalcitrant acne. A reminder to note on all culture requisitions to grow gram negatives because not all labs will grow gram negatives on a skin swab. Counseling should also be given to those patients who wear makeup, which should include techniques to clean and sanitize makeup applicators including brushes, tools, and towels. Blenders are known to be used “wet” and are not dried when washed.
It is my recommendation that blenders be a one-time-use-only tool and disposed of after EVERY application. Instructions provided in my clinic are to wash all devices and brushes once a week with hot soapy water, and blow dry with a hair dryer immediately afterward. Lipsticks, mascara wands, and lip glosses should be sanitized with alcohol once a month. Finally, all products need to be disposed of after their expiry.
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.
Resource
Basher A, Lambert P. J Appl Microbiol. 2019. doi: 10.1111/jam.14479.
Recalcitrant acne is a common, unwavering problem in dermatology practices nationwide. However, both gram positive and gram negative infections of the skin can go undiagnosed in patients with acne resistant to the armamentarium of oral and topical therapeutics. Although I often use isotretinoin in patients with cystic or recalcitrant acne, I almost always do a culture prior to initiating therapy, and more often than not, have discovered patients have gram negative and gram positive skin infections resistant to antibiotics commonly used to treat acne.
study by Bashir and Lambert published in the Journal of Applied Microbiology, 70%-90% of makeup products tested – including lipstick, lip gloss, beauty blenders, eyeliners, and mascara – were found to be contaminated with bacteria. Staphylococcus aureus, Pseudomonas aeruginosa, and Escherichia coli were the most common culprits, and the product with the highest contamination rates were beauty blenders (the small sponges used to apply makeup), which also had high rates of fungal contamination.
Expiration dates on cosmetic products are used to indicate the length of time a preservative in a product can control bacterial contamination. They are printed on packaging as an open jar symbol with the 3M, 6M, 9M, and 12M label for the number of months the product can be opened and used. Unfortunately and unknowingly, most consumers use products beyond the expiration date, and the most common offender is mascara.
Gram positive and gram negative skin infections should be ruled out in all cases of recalcitrant acne. A reminder to note on all culture requisitions to grow gram negatives because not all labs will grow gram negatives on a skin swab. Counseling should also be given to those patients who wear makeup, which should include techniques to clean and sanitize makeup applicators including brushes, tools, and towels. Blenders are known to be used “wet” and are not dried when washed.
It is my recommendation that blenders be a one-time-use-only tool and disposed of after EVERY application. Instructions provided in my clinic are to wash all devices and brushes once a week with hot soapy water, and blow dry with a hair dryer immediately afterward. Lipsticks, mascara wands, and lip glosses should be sanitized with alcohol once a month. Finally, all products need to be disposed of after their expiry.
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.
Resource
Basher A, Lambert P. J Appl Microbiol. 2019. doi: 10.1111/jam.14479.
Nonablative laser improved PIH in patients with darker skin
Yoon‐Soo Cindy Bae, MD, and colleagues reported.
Among patients treated with the nonablative fractional 1,927 nm laser, there was a mean improvement of about 43% in hyperpigmented areas, and no side effects were reported, wrote Dr. Bae, of the department of dermatology at New York University and the Laser & Skin Surgery Center of New York, and coauthors in Lasers in Surgery and Medicine.
Lasers have not been the first choice for hyperpigmentation in Fitzpatrick skin types IV, V, and VI, they pointed out. More commonly used treatments are hydroquinone and chemical peels that use glycolic acid or salicylic acid. But these are not always ideal options, Dr. Bae said in an interview.
“There are side effects to medical therapy. The drawbacks of medical therapy include compliance issues, risk of skin irritation from the product ... and a risk of hyperpigmentation specifically for hydroquinone. There are also risks to laser therapy, including dyspigmentation and scarring,” she added. “However, the laser we used is a low energy, nonablative type of laser, so the risk of scarring is extremely rare and the dyspigmentation is actually what we are aiming to treat.”
The retrospective study comprised 61 patients with PIH who had received more than one treatment with the low energy fractionated 1,927 nm diode laser between 2013 and 2016. Most were Fitzpatrick type IV (73.8%). The remainder were Type V (16.4%) and Type VI (9.8%). The most common treatment site was the face or cheeks (68.9%), followed by legs (13%), the rest of the cases were unspecified.
Patients had received treatment with the laser with fixed fluence at 5 mJ, fixed spot size of 140 micrometers, depth of 170 micrometers, and 5% coverage. They required several treatments: 15 had two, 14 had three, 16 had four, and the remainder had five or more. Topical treatment data were not collected. Photographs taken before treatment and before the last treatment were evaluated by dermatologists who had not treated the patients. Based on those evaluations, the mean improvement was a statistically significant 43.2%.
There did not, however, appear to be much difference between the treatment groups. The mean improvement among patients with two treatments was 44.5%; three treatments, 44.29%; four treatments, 40.63%; five or more treatments, 43.75%.
Although those with darker skin types tended to have better results, there were no statistically significant differences between the skin-type groups. Among those with Fitzpatrick skin type IV, the mean improvement was 40.39%; skin type V, 47.25%; and skin type VI, 57.92%.
“The fact that there was no correlation between Fitzpatrick skin type … and average percent improvement demonstrates that this laser is a viable treatment option for patients with very dark skin,” the authors wrote. “There were also no significant differences between the average percent improvements for people receiving different numbers of treatments. A trend was observed that favored treating patients with darker skin type; however, this lacked statistical significance. This may have been due to an underpowered study.”
Limitations of the study included the retrospective design and nonstandardization of photographs; “further studies with prospective controlled designs are needed to confirm our findings,” they added.
No funding or disclosure information was provided.
[email protected]
SOURCE: Bae YS et al. Lasers Surg Med. 2019 Oct 29. doi: 10.1002/lsm.23173.
Yoon‐Soo Cindy Bae, MD, and colleagues reported.
Among patients treated with the nonablative fractional 1,927 nm laser, there was a mean improvement of about 43% in hyperpigmented areas, and no side effects were reported, wrote Dr. Bae, of the department of dermatology at New York University and the Laser & Skin Surgery Center of New York, and coauthors in Lasers in Surgery and Medicine.
Lasers have not been the first choice for hyperpigmentation in Fitzpatrick skin types IV, V, and VI, they pointed out. More commonly used treatments are hydroquinone and chemical peels that use glycolic acid or salicylic acid. But these are not always ideal options, Dr. Bae said in an interview.
“There are side effects to medical therapy. The drawbacks of medical therapy include compliance issues, risk of skin irritation from the product ... and a risk of hyperpigmentation specifically for hydroquinone. There are also risks to laser therapy, including dyspigmentation and scarring,” she added. “However, the laser we used is a low energy, nonablative type of laser, so the risk of scarring is extremely rare and the dyspigmentation is actually what we are aiming to treat.”
The retrospective study comprised 61 patients with PIH who had received more than one treatment with the low energy fractionated 1,927 nm diode laser between 2013 and 2016. Most were Fitzpatrick type IV (73.8%). The remainder were Type V (16.4%) and Type VI (9.8%). The most common treatment site was the face or cheeks (68.9%), followed by legs (13%), the rest of the cases were unspecified.
Patients had received treatment with the laser with fixed fluence at 5 mJ, fixed spot size of 140 micrometers, depth of 170 micrometers, and 5% coverage. They required several treatments: 15 had two, 14 had three, 16 had four, and the remainder had five or more. Topical treatment data were not collected. Photographs taken before treatment and before the last treatment were evaluated by dermatologists who had not treated the patients. Based on those evaluations, the mean improvement was a statistically significant 43.2%.
There did not, however, appear to be much difference between the treatment groups. The mean improvement among patients with two treatments was 44.5%; three treatments, 44.29%; four treatments, 40.63%; five or more treatments, 43.75%.
Although those with darker skin types tended to have better results, there were no statistically significant differences between the skin-type groups. Among those with Fitzpatrick skin type IV, the mean improvement was 40.39%; skin type V, 47.25%; and skin type VI, 57.92%.
“The fact that there was no correlation between Fitzpatrick skin type … and average percent improvement demonstrates that this laser is a viable treatment option for patients with very dark skin,” the authors wrote. “There were also no significant differences between the average percent improvements for people receiving different numbers of treatments. A trend was observed that favored treating patients with darker skin type; however, this lacked statistical significance. This may have been due to an underpowered study.”
Limitations of the study included the retrospective design and nonstandardization of photographs; “further studies with prospective controlled designs are needed to confirm our findings,” they added.
No funding or disclosure information was provided.
[email protected]
SOURCE: Bae YS et al. Lasers Surg Med. 2019 Oct 29. doi: 10.1002/lsm.23173.
Yoon‐Soo Cindy Bae, MD, and colleagues reported.
Among patients treated with the nonablative fractional 1,927 nm laser, there was a mean improvement of about 43% in hyperpigmented areas, and no side effects were reported, wrote Dr. Bae, of the department of dermatology at New York University and the Laser & Skin Surgery Center of New York, and coauthors in Lasers in Surgery and Medicine.
Lasers have not been the first choice for hyperpigmentation in Fitzpatrick skin types IV, V, and VI, they pointed out. More commonly used treatments are hydroquinone and chemical peels that use glycolic acid or salicylic acid. But these are not always ideal options, Dr. Bae said in an interview.
“There are side effects to medical therapy. The drawbacks of medical therapy include compliance issues, risk of skin irritation from the product ... and a risk of hyperpigmentation specifically for hydroquinone. There are also risks to laser therapy, including dyspigmentation and scarring,” she added. “However, the laser we used is a low energy, nonablative type of laser, so the risk of scarring is extremely rare and the dyspigmentation is actually what we are aiming to treat.”
The retrospective study comprised 61 patients with PIH who had received more than one treatment with the low energy fractionated 1,927 nm diode laser between 2013 and 2016. Most were Fitzpatrick type IV (73.8%). The remainder were Type V (16.4%) and Type VI (9.8%). The most common treatment site was the face or cheeks (68.9%), followed by legs (13%), the rest of the cases were unspecified.
Patients had received treatment with the laser with fixed fluence at 5 mJ, fixed spot size of 140 micrometers, depth of 170 micrometers, and 5% coverage. They required several treatments: 15 had two, 14 had three, 16 had four, and the remainder had five or more. Topical treatment data were not collected. Photographs taken before treatment and before the last treatment were evaluated by dermatologists who had not treated the patients. Based on those evaluations, the mean improvement was a statistically significant 43.2%.
There did not, however, appear to be much difference between the treatment groups. The mean improvement among patients with two treatments was 44.5%; three treatments, 44.29%; four treatments, 40.63%; five or more treatments, 43.75%.
Although those with darker skin types tended to have better results, there were no statistically significant differences between the skin-type groups. Among those with Fitzpatrick skin type IV, the mean improvement was 40.39%; skin type V, 47.25%; and skin type VI, 57.92%.
“The fact that there was no correlation between Fitzpatrick skin type … and average percent improvement demonstrates that this laser is a viable treatment option for patients with very dark skin,” the authors wrote. “There were also no significant differences between the average percent improvements for people receiving different numbers of treatments. A trend was observed that favored treating patients with darker skin type; however, this lacked statistical significance. This may have been due to an underpowered study.”
Limitations of the study included the retrospective design and nonstandardization of photographs; “further studies with prospective controlled designs are needed to confirm our findings,” they added.
No funding or disclosure information was provided.
[email protected]
SOURCE: Bae YS et al. Lasers Surg Med. 2019 Oct 29. doi: 10.1002/lsm.23173.
FROM LASERS IN SURGERY AND MEDICINE
Halal nail polish
Ever heard of halal nail polish? As an expert on all things hair, skin, and nails, I was dismayed when I walked into my local nail salon and saw this new category of nail polish I’d never heard of before. About 10 halal nail polishes were available in an array of beautiful colors. This nail salon was already branded as “nontoxic,” carrying only “8-free” nail polishes, vegan, and cruelty-free body and cleaning products – as well as no acrylics or UV light devices used for drying manicured nails or processing gel nails. With the salon already providing 8-free nail polishes, what was the difference between those and halal nail polishes?
As I did my Google search while sitting in the salon chair, I got the answer both from salon employees and the Internet, and also found several other brands of halal nail polishes sold on Amazon.
The main ingredient in traditional nail lacquer is nitrocellulose, a mixture of an indigestible plant fiber. Once used for gunpowder and blast mining in the 19th century, today, nitrocellulose is used for many purposes for holding materials together, such as photography film, and diagnostic tests that involve antigen-antibody binding, such as pregnancy tests. In a bottle of traditional nail polish, nitrocellulose is dissolved in a chemical solvent (typically ethyl acetate), along with pigment colors and plasticizers. The solvent quickly evaporates and is what gives nail polish its chemical smell. Once painted on the nail, the solvent gradually evaporates away entirely and the nitrocellulose is left behind, drying into a solid film on the nail. The same solvent molecule is in nonacetone nail polish remover, which simply redissolves the nitrocellulose back into a liquid so it can be wiped off.
Some nail polish may also include “pearl essence” to give a shiny look, like the silvery iridescence of fish scales. In fact, these polishes have contained ground up iridescent fish scales, but because of overfishing and cost, cheaper mineral alternatives are now more commonly used to give this shiny appearance.
Traditional nail polish contains tight molecular bonds that are impermeable to air and water. The tight bonds create fewer interstitial spaces for water to pass through. Nail polishes with polymer blends that help them withstand or make them more impermeable to water often chip less quickly and stay shinier longer.
While nail polishes are generally deemed safe, newer categories of 3-, 5-, or 8-free nail polishes containing fewer or different ingredients to preserve the product or give it it’s finish have been developed because of health concerns over some ingredients, for both users and cosmetologists. The 8-free nail polish does not contain dibutyl phthalate (DBP), toluene, formaldehyde, formaldehyde resin, camphor, ethyl tosylamide, parabens, or xylene. Three-, 5-, or 8- free doesn’t always mean that the lacquer has fewer chemicals; it may have alternative ingredients that also warrant study comparison to traditional ingredients.
Halal nail polish is in another category of “breathable nail polish,” which is not purely a function of the ingredient or lack of ingredients, but has to do with the way it is formulated. Compared with the tight molecular bonds of traditional nail polish, “breathable” polishes have a more staggered structure, which allows air and water molecules to pass through the polish. Halal nail polish is often free of the same ingredients as 8-free polishes, and some brands are even 13-free, animal product free, and do not require a base or top coat, but may also contain ingredients like bis (glycidoxyphenyl) propane/bisaminomethylnorbornae. Those ingredients are not typically used in traditional nail polish and may play a role in the unique staggered structure allowing air and water to pass through the polish. Halal nail polish may not last as long on nails as does traditional nail polish, usually a few days to a week.
Our nails are circulating breathing structures, with our nail plates being appendages over our nail beds with a rich pulse and blood supply. The main oxygen supply to the ends of our digits comes from our blood supply, not via oxygen through the nail plate, but wearing nail polish continuously can affect our nails. Oxygen saturation is detected through the end of our digits and nails when vital signs are being checked (less so when nail polish is present). As a continual wearer of nail polish for over 30 years, I can personally attest to certain types of onychodystrophy (white spots and discoloration on toe nails) from overuse of dark nail polish colors. Taking a break from polish and using these more “breathable” polishes could also potentially be a solution to this common complaint of nonfungal onychodystrophy.
Dr. Wesley and Dr. Talakoub 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.
Ever heard of halal nail polish? As an expert on all things hair, skin, and nails, I was dismayed when I walked into my local nail salon and saw this new category of nail polish I’d never heard of before. About 10 halal nail polishes were available in an array of beautiful colors. This nail salon was already branded as “nontoxic,” carrying only “8-free” nail polishes, vegan, and cruelty-free body and cleaning products – as well as no acrylics or UV light devices used for drying manicured nails or processing gel nails. With the salon already providing 8-free nail polishes, what was the difference between those and halal nail polishes?
As I did my Google search while sitting in the salon chair, I got the answer both from salon employees and the Internet, and also found several other brands of halal nail polishes sold on Amazon.
The main ingredient in traditional nail lacquer is nitrocellulose, a mixture of an indigestible plant fiber. Once used for gunpowder and blast mining in the 19th century, today, nitrocellulose is used for many purposes for holding materials together, such as photography film, and diagnostic tests that involve antigen-antibody binding, such as pregnancy tests. In a bottle of traditional nail polish, nitrocellulose is dissolved in a chemical solvent (typically ethyl acetate), along with pigment colors and plasticizers. The solvent quickly evaporates and is what gives nail polish its chemical smell. Once painted on the nail, the solvent gradually evaporates away entirely and the nitrocellulose is left behind, drying into a solid film on the nail. The same solvent molecule is in nonacetone nail polish remover, which simply redissolves the nitrocellulose back into a liquid so it can be wiped off.
Some nail polish may also include “pearl essence” to give a shiny look, like the silvery iridescence of fish scales. In fact, these polishes have contained ground up iridescent fish scales, but because of overfishing and cost, cheaper mineral alternatives are now more commonly used to give this shiny appearance.
Traditional nail polish contains tight molecular bonds that are impermeable to air and water. The tight bonds create fewer interstitial spaces for water to pass through. Nail polishes with polymer blends that help them withstand or make them more impermeable to water often chip less quickly and stay shinier longer.
While nail polishes are generally deemed safe, newer categories of 3-, 5-, or 8-free nail polishes containing fewer or different ingredients to preserve the product or give it it’s finish have been developed because of health concerns over some ingredients, for both users and cosmetologists. The 8-free nail polish does not contain dibutyl phthalate (DBP), toluene, formaldehyde, formaldehyde resin, camphor, ethyl tosylamide, parabens, or xylene. Three-, 5-, or 8- free doesn’t always mean that the lacquer has fewer chemicals; it may have alternative ingredients that also warrant study comparison to traditional ingredients.
Halal nail polish is in another category of “breathable nail polish,” which is not purely a function of the ingredient or lack of ingredients, but has to do with the way it is formulated. Compared with the tight molecular bonds of traditional nail polish, “breathable” polishes have a more staggered structure, which allows air and water molecules to pass through the polish. Halal nail polish is often free of the same ingredients as 8-free polishes, and some brands are even 13-free, animal product free, and do not require a base or top coat, but may also contain ingredients like bis (glycidoxyphenyl) propane/bisaminomethylnorbornae. Those ingredients are not typically used in traditional nail polish and may play a role in the unique staggered structure allowing air and water to pass through the polish. Halal nail polish may not last as long on nails as does traditional nail polish, usually a few days to a week.
Our nails are circulating breathing structures, with our nail plates being appendages over our nail beds with a rich pulse and blood supply. The main oxygen supply to the ends of our digits comes from our blood supply, not via oxygen through the nail plate, but wearing nail polish continuously can affect our nails. Oxygen saturation is detected through the end of our digits and nails when vital signs are being checked (less so when nail polish is present). As a continual wearer of nail polish for over 30 years, I can personally attest to certain types of onychodystrophy (white spots and discoloration on toe nails) from overuse of dark nail polish colors. Taking a break from polish and using these more “breathable” polishes could also potentially be a solution to this common complaint of nonfungal onychodystrophy.
Dr. Wesley and Dr. Talakoub 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.
Ever heard of halal nail polish? As an expert on all things hair, skin, and nails, I was dismayed when I walked into my local nail salon and saw this new category of nail polish I’d never heard of before. About 10 halal nail polishes were available in an array of beautiful colors. This nail salon was already branded as “nontoxic,” carrying only “8-free” nail polishes, vegan, and cruelty-free body and cleaning products – as well as no acrylics or UV light devices used for drying manicured nails or processing gel nails. With the salon already providing 8-free nail polishes, what was the difference between those and halal nail polishes?
As I did my Google search while sitting in the salon chair, I got the answer both from salon employees and the Internet, and also found several other brands of halal nail polishes sold on Amazon.
The main ingredient in traditional nail lacquer is nitrocellulose, a mixture of an indigestible plant fiber. Once used for gunpowder and blast mining in the 19th century, today, nitrocellulose is used for many purposes for holding materials together, such as photography film, and diagnostic tests that involve antigen-antibody binding, such as pregnancy tests. In a bottle of traditional nail polish, nitrocellulose is dissolved in a chemical solvent (typically ethyl acetate), along with pigment colors and plasticizers. The solvent quickly evaporates and is what gives nail polish its chemical smell. Once painted on the nail, the solvent gradually evaporates away entirely and the nitrocellulose is left behind, drying into a solid film on the nail. The same solvent molecule is in nonacetone nail polish remover, which simply redissolves the nitrocellulose back into a liquid so it can be wiped off.
Some nail polish may also include “pearl essence” to give a shiny look, like the silvery iridescence of fish scales. In fact, these polishes have contained ground up iridescent fish scales, but because of overfishing and cost, cheaper mineral alternatives are now more commonly used to give this shiny appearance.
Traditional nail polish contains tight molecular bonds that are impermeable to air and water. The tight bonds create fewer interstitial spaces for water to pass through. Nail polishes with polymer blends that help them withstand or make them more impermeable to water often chip less quickly and stay shinier longer.
While nail polishes are generally deemed safe, newer categories of 3-, 5-, or 8-free nail polishes containing fewer or different ingredients to preserve the product or give it it’s finish have been developed because of health concerns over some ingredients, for both users and cosmetologists. The 8-free nail polish does not contain dibutyl phthalate (DBP), toluene, formaldehyde, formaldehyde resin, camphor, ethyl tosylamide, parabens, or xylene. Three-, 5-, or 8- free doesn’t always mean that the lacquer has fewer chemicals; it may have alternative ingredients that also warrant study comparison to traditional ingredients.
Halal nail polish is in another category of “breathable nail polish,” which is not purely a function of the ingredient or lack of ingredients, but has to do with the way it is formulated. Compared with the tight molecular bonds of traditional nail polish, “breathable” polishes have a more staggered structure, which allows air and water molecules to pass through the polish. Halal nail polish is often free of the same ingredients as 8-free polishes, and some brands are even 13-free, animal product free, and do not require a base or top coat, but may also contain ingredients like bis (glycidoxyphenyl) propane/bisaminomethylnorbornae. Those ingredients are not typically used in traditional nail polish and may play a role in the unique staggered structure allowing air and water to pass through the polish. Halal nail polish may not last as long on nails as does traditional nail polish, usually a few days to a week.
Our nails are circulating breathing structures, with our nail plates being appendages over our nail beds with a rich pulse and blood supply. The main oxygen supply to the ends of our digits comes from our blood supply, not via oxygen through the nail plate, but wearing nail polish continuously can affect our nails. Oxygen saturation is detected through the end of our digits and nails when vital signs are being checked (less so when nail polish is present). As a continual wearer of nail polish for over 30 years, I can personally attest to certain types of onychodystrophy (white spots and discoloration on toe nails) from overuse of dark nail polish colors. Taking a break from polish and using these more “breathable” polishes could also potentially be a solution to this common complaint of nonfungal onychodystrophy.
Dr. Wesley and Dr. Talakoub 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.
Piceatannol: The other potent antioxidant in grapes and wine
Present in grape skins, passion fruit, and wine among several other plants and their derivatives, piceatannol is a natural stilbene, as well as an analogue of the much-studied antioxidant resveratrol. Similarly, piceatannol is thought to provide robust antioxidant and other salutary benefits.1,2
Two decades ago, the hydroxystilbenes piceatannol and transresveratrol were found, in a study of the antioxidant potential of natural products, to hinder carcinogen-induced preneoplastic lesion development in a murine mammary gland organ culture model.3 Piceatannol is naturally present in various plants and is a primary active ingredient in several. It is known to exhibit a wide range of biologic activities, including antioxidant, antibacterial, anti-inflammatory, and anticancer functions. Native to southern and southeastern Asia, Rhodomyrtus tomentosa (rose myrtle, which is a member of the Myrtaceae family), which has been utilized in traditional medicine in China, Malaysia, and Vietnam for myriad indications including wound healing, contains piceatannol as an active ingredient.4
The reported cutaneous benefits of piceatannol include promotion of collagen synthesis, suppression of melanin production, induction of the antioxidant glutathione, and the destruction of reactive oxygen species.5
Antimelanogenic activity
In 2007, Yokozawa and Kim looked into the capacity of piceatannol, given its antioxidant activities, to suppress melanogenesis. This ability was tested using the B16F10 melanoma culture system, and piceatannol was found to have a potent antityrosinase activity – stronger than kojic acid and resveratrol. Melanin content was also down-regulated by piceatannol. In addition, the researchers determined that piceatannol inhibited reactive oxygen species production, which improved the ratio of glutathione to oxidized glutathione. They concluded that the observed antimelanogenic activities of piceatannol could be attributed to its dynamic antioxidant qualities.6
Four years later, Matsui et al. ascertained that piceatannol (3,4,3’,5’-tetrahydroxy-trans-stilbene) is present in copious supply in the seeds of Passiflora edulis (passion fruit) and that this constituent of the fruit largely accounts for its antimelanogenic activities, as well as its promotion of collagen production.7
Anti-inflammatory activity
In 2014, Liu et al. used female HR-1 hairless mice in a study to shed light on the molecular mechanisms of the anti-inflammatory activity of topically applied piceatannol in vivo. Mice, either pretreated with piceatannol or not, were topically treated with 12-O-tetradecanoylphorbol-13-acetate (TPA), and pretreatment was found to yield diminished TPA-induced cyclooxygenase-2 (COX-2) expression and inducible nitric oxide synthase (iNOS). This occurred through the suppression of NF-kappa-B and AP-1 activation as a result of hindering IKK-beta activity and phosphorylation of mitogen-activated protein kinases.8
Photoprotection
Maruki-Uchida et al. studied the effects of the antioxidants piceatannol and its dimer scirpusin B, which is found in passion fruit, on human keratinocytes. In this 2013 study, they found that piceatannol dose-dependently up-regulated glutathione levels. In addition, piceatannol pretreatment blocked UVB-induced reactive oxygen species development. Pretreatment with piceatannol also reduced matrix metalloproteinase-1 activity in a nonirradiated medium of fibroblasts. The investigators concluded that piceatannol and piceatannol-rich passion fruit seed extract warrant attention as possible antiphotoaging cosmetic agents.9
With use of cultured normal human epidermal keratinocytes, Shiratake et al. in 2015 screened more than 50 plant extracts for ingredients that hinder UVB-induced damage. They identified the fruit R. tomentosa as the strongest inhibitor, with its primary component, piceatannol, demonstrating protective activities against UVB. Piceatannol decreased UVB-induced cyclobutane pyrimidine dimer synthesis, diminished prostaglandin E2 secretion, and promoted the cellular enzyme activity of DNA polymerases. The investigators concluded that rose myrtle extracts and piceatannol are potential photoprotective agents.10
Dry skin
In a 2018 randomized, placebo-controlled, double-blind trial Maruki-Uchida et al. assessed the effects of passion fruit seed extract on the skin of 32 healthy Japanese women (aged 35-54 years). Over an 8-week period, the subjects, all with dry skin, received either 5 mg of piceatannol (derived from passion fruit seed extract) or a dextrin placebo. Significant increases in cutaneous moisture content were noted in the subjects who consumed passion fruit after 4 and 8 weeks, compared with baseline and with the placebo group. Questionnaire results also indicated that perspiration and fatigue significantly decreased in the passion fruit group as compared with the placebo group. The researchers concluded that consumption of piceatannol-rich passion fruit seed extract can ameliorate dry skin and diminish fatigue.5
Conclusion
Although it gets much less attention than the related antioxidant resveratrol, piceatannol is hardly an insignificant bioactive compound. There is increasing evidence that suggests its potency as an antioxidant, as well as a potentially useful ingredient in skincare, particularly in addressing photoaging and dry skin. Much more research is necessary, of course, to determine how substantial a role this stilbene can play in providing skin protection and treatment.
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 wrote two textbooks, “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), as well as a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].
References
1. Phytother Res. 2014 Nov;28(11):1581-8.
2. Biogerontology. 2017 Aug;18(4):499-516.
3. Comb Chem High Throughput Screen. 1998 Apr;1(1):35-46.
4. Biomolecules. 2019 Feb 21. doi: 10.3390/biom9020076.
5. J Nutr Sci Vitaminol (Tokyo). 2018;64(1):75-80.
6. Biol Pharm Bull. 2007 Nov;30(11):2007-11.
7. J Agric Food Chem. 2010 Oct 27;58(20):11112-8.
8. Inflamm Res. 2014 Dec;63(12):1013-21.
9. Biol Pharm Bull. 2013;36(5):845-9.
10. Mol Med Rep. 2015 Oct;12(4):5857-64.
Present in grape skins, passion fruit, and wine among several other plants and their derivatives, piceatannol is a natural stilbene, as well as an analogue of the much-studied antioxidant resveratrol. Similarly, piceatannol is thought to provide robust antioxidant and other salutary benefits.1,2
Two decades ago, the hydroxystilbenes piceatannol and transresveratrol were found, in a study of the antioxidant potential of natural products, to hinder carcinogen-induced preneoplastic lesion development in a murine mammary gland organ culture model.3 Piceatannol is naturally present in various plants and is a primary active ingredient in several. It is known to exhibit a wide range of biologic activities, including antioxidant, antibacterial, anti-inflammatory, and anticancer functions. Native to southern and southeastern Asia, Rhodomyrtus tomentosa (rose myrtle, which is a member of the Myrtaceae family), which has been utilized in traditional medicine in China, Malaysia, and Vietnam for myriad indications including wound healing, contains piceatannol as an active ingredient.4
The reported cutaneous benefits of piceatannol include promotion of collagen synthesis, suppression of melanin production, induction of the antioxidant glutathione, and the destruction of reactive oxygen species.5
Antimelanogenic activity
In 2007, Yokozawa and Kim looked into the capacity of piceatannol, given its antioxidant activities, to suppress melanogenesis. This ability was tested using the B16F10 melanoma culture system, and piceatannol was found to have a potent antityrosinase activity – stronger than kojic acid and resveratrol. Melanin content was also down-regulated by piceatannol. In addition, the researchers determined that piceatannol inhibited reactive oxygen species production, which improved the ratio of glutathione to oxidized glutathione. They concluded that the observed antimelanogenic activities of piceatannol could be attributed to its dynamic antioxidant qualities.6
Four years later, Matsui et al. ascertained that piceatannol (3,4,3’,5’-tetrahydroxy-trans-stilbene) is present in copious supply in the seeds of Passiflora edulis (passion fruit) and that this constituent of the fruit largely accounts for its antimelanogenic activities, as well as its promotion of collagen production.7
Anti-inflammatory activity
In 2014, Liu et al. used female HR-1 hairless mice in a study to shed light on the molecular mechanisms of the anti-inflammatory activity of topically applied piceatannol in vivo. Mice, either pretreated with piceatannol or not, were topically treated with 12-O-tetradecanoylphorbol-13-acetate (TPA), and pretreatment was found to yield diminished TPA-induced cyclooxygenase-2 (COX-2) expression and inducible nitric oxide synthase (iNOS). This occurred through the suppression of NF-kappa-B and AP-1 activation as a result of hindering IKK-beta activity and phosphorylation of mitogen-activated protein kinases.8
Photoprotection
Maruki-Uchida et al. studied the effects of the antioxidants piceatannol and its dimer scirpusin B, which is found in passion fruit, on human keratinocytes. In this 2013 study, they found that piceatannol dose-dependently up-regulated glutathione levels. In addition, piceatannol pretreatment blocked UVB-induced reactive oxygen species development. Pretreatment with piceatannol also reduced matrix metalloproteinase-1 activity in a nonirradiated medium of fibroblasts. The investigators concluded that piceatannol and piceatannol-rich passion fruit seed extract warrant attention as possible antiphotoaging cosmetic agents.9
With use of cultured normal human epidermal keratinocytes, Shiratake et al. in 2015 screened more than 50 plant extracts for ingredients that hinder UVB-induced damage. They identified the fruit R. tomentosa as the strongest inhibitor, with its primary component, piceatannol, demonstrating protective activities against UVB. Piceatannol decreased UVB-induced cyclobutane pyrimidine dimer synthesis, diminished prostaglandin E2 secretion, and promoted the cellular enzyme activity of DNA polymerases. The investigators concluded that rose myrtle extracts and piceatannol are potential photoprotective agents.10
Dry skin
In a 2018 randomized, placebo-controlled, double-blind trial Maruki-Uchida et al. assessed the effects of passion fruit seed extract on the skin of 32 healthy Japanese women (aged 35-54 years). Over an 8-week period, the subjects, all with dry skin, received either 5 mg of piceatannol (derived from passion fruit seed extract) or a dextrin placebo. Significant increases in cutaneous moisture content were noted in the subjects who consumed passion fruit after 4 and 8 weeks, compared with baseline and with the placebo group. Questionnaire results also indicated that perspiration and fatigue significantly decreased in the passion fruit group as compared with the placebo group. The researchers concluded that consumption of piceatannol-rich passion fruit seed extract can ameliorate dry skin and diminish fatigue.5
Conclusion
Although it gets much less attention than the related antioxidant resveratrol, piceatannol is hardly an insignificant bioactive compound. There is increasing evidence that suggests its potency as an antioxidant, as well as a potentially useful ingredient in skincare, particularly in addressing photoaging and dry skin. Much more research is necessary, of course, to determine how substantial a role this stilbene can play in providing skin protection and treatment.
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 wrote two textbooks, “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), as well as a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].
References
1. Phytother Res. 2014 Nov;28(11):1581-8.
2. Biogerontology. 2017 Aug;18(4):499-516.
3. Comb Chem High Throughput Screen. 1998 Apr;1(1):35-46.
4. Biomolecules. 2019 Feb 21. doi: 10.3390/biom9020076.
5. J Nutr Sci Vitaminol (Tokyo). 2018;64(1):75-80.
6. Biol Pharm Bull. 2007 Nov;30(11):2007-11.
7. J Agric Food Chem. 2010 Oct 27;58(20):11112-8.
8. Inflamm Res. 2014 Dec;63(12):1013-21.
9. Biol Pharm Bull. 2013;36(5):845-9.
10. Mol Med Rep. 2015 Oct;12(4):5857-64.
Present in grape skins, passion fruit, and wine among several other plants and their derivatives, piceatannol is a natural stilbene, as well as an analogue of the much-studied antioxidant resveratrol. Similarly, piceatannol is thought to provide robust antioxidant and other salutary benefits.1,2
Two decades ago, the hydroxystilbenes piceatannol and transresveratrol were found, in a study of the antioxidant potential of natural products, to hinder carcinogen-induced preneoplastic lesion development in a murine mammary gland organ culture model.3 Piceatannol is naturally present in various plants and is a primary active ingredient in several. It is known to exhibit a wide range of biologic activities, including antioxidant, antibacterial, anti-inflammatory, and anticancer functions. Native to southern and southeastern Asia, Rhodomyrtus tomentosa (rose myrtle, which is a member of the Myrtaceae family), which has been utilized in traditional medicine in China, Malaysia, and Vietnam for myriad indications including wound healing, contains piceatannol as an active ingredient.4
The reported cutaneous benefits of piceatannol include promotion of collagen synthesis, suppression of melanin production, induction of the antioxidant glutathione, and the destruction of reactive oxygen species.5
Antimelanogenic activity
In 2007, Yokozawa and Kim looked into the capacity of piceatannol, given its antioxidant activities, to suppress melanogenesis. This ability was tested using the B16F10 melanoma culture system, and piceatannol was found to have a potent antityrosinase activity – stronger than kojic acid and resveratrol. Melanin content was also down-regulated by piceatannol. In addition, the researchers determined that piceatannol inhibited reactive oxygen species production, which improved the ratio of glutathione to oxidized glutathione. They concluded that the observed antimelanogenic activities of piceatannol could be attributed to its dynamic antioxidant qualities.6
Four years later, Matsui et al. ascertained that piceatannol (3,4,3’,5’-tetrahydroxy-trans-stilbene) is present in copious supply in the seeds of Passiflora edulis (passion fruit) and that this constituent of the fruit largely accounts for its antimelanogenic activities, as well as its promotion of collagen production.7
Anti-inflammatory activity
In 2014, Liu et al. used female HR-1 hairless mice in a study to shed light on the molecular mechanisms of the anti-inflammatory activity of topically applied piceatannol in vivo. Mice, either pretreated with piceatannol or not, were topically treated with 12-O-tetradecanoylphorbol-13-acetate (TPA), and pretreatment was found to yield diminished TPA-induced cyclooxygenase-2 (COX-2) expression and inducible nitric oxide synthase (iNOS). This occurred through the suppression of NF-kappa-B and AP-1 activation as a result of hindering IKK-beta activity and phosphorylation of mitogen-activated protein kinases.8
Photoprotection
Maruki-Uchida et al. studied the effects of the antioxidants piceatannol and its dimer scirpusin B, which is found in passion fruit, on human keratinocytes. In this 2013 study, they found that piceatannol dose-dependently up-regulated glutathione levels. In addition, piceatannol pretreatment blocked UVB-induced reactive oxygen species development. Pretreatment with piceatannol also reduced matrix metalloproteinase-1 activity in a nonirradiated medium of fibroblasts. The investigators concluded that piceatannol and piceatannol-rich passion fruit seed extract warrant attention as possible antiphotoaging cosmetic agents.9
With use of cultured normal human epidermal keratinocytes, Shiratake et al. in 2015 screened more than 50 plant extracts for ingredients that hinder UVB-induced damage. They identified the fruit R. tomentosa as the strongest inhibitor, with its primary component, piceatannol, demonstrating protective activities against UVB. Piceatannol decreased UVB-induced cyclobutane pyrimidine dimer synthesis, diminished prostaglandin E2 secretion, and promoted the cellular enzyme activity of DNA polymerases. The investigators concluded that rose myrtle extracts and piceatannol are potential photoprotective agents.10
Dry skin
In a 2018 randomized, placebo-controlled, double-blind trial Maruki-Uchida et al. assessed the effects of passion fruit seed extract on the skin of 32 healthy Japanese women (aged 35-54 years). Over an 8-week period, the subjects, all with dry skin, received either 5 mg of piceatannol (derived from passion fruit seed extract) or a dextrin placebo. Significant increases in cutaneous moisture content were noted in the subjects who consumed passion fruit after 4 and 8 weeks, compared with baseline and with the placebo group. Questionnaire results also indicated that perspiration and fatigue significantly decreased in the passion fruit group as compared with the placebo group. The researchers concluded that consumption of piceatannol-rich passion fruit seed extract can ameliorate dry skin and diminish fatigue.5
Conclusion
Although it gets much less attention than the related antioxidant resveratrol, piceatannol is hardly an insignificant bioactive compound. There is increasing evidence that suggests its potency as an antioxidant, as well as a potentially useful ingredient in skincare, particularly in addressing photoaging and dry skin. Much more research is necessary, of course, to determine how substantial a role this stilbene can play in providing skin protection and treatment.
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 wrote two textbooks, “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002) and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), as well as a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].
References
1. Phytother Res. 2014 Nov;28(11):1581-8.
2. Biogerontology. 2017 Aug;18(4):499-516.
3. Comb Chem High Throughput Screen. 1998 Apr;1(1):35-46.
4. Biomolecules. 2019 Feb 21. doi: 10.3390/biom9020076.
5. J Nutr Sci Vitaminol (Tokyo). 2018;64(1):75-80.
6. Biol Pharm Bull. 2007 Nov;30(11):2007-11.
7. J Agric Food Chem. 2010 Oct 27;58(20):11112-8.
8. Inflamm Res. 2014 Dec;63(12):1013-21.
9. Biol Pharm Bull. 2013;36(5):845-9.
10. Mol Med Rep. 2015 Oct;12(4):5857-64.
Comment on “Intraoperative Electrosurgical Smoke During Outpatient Surgery: A Survey of Dermatologic Surgeon and Staff Preferences”
To the Editor:
We read with great interest the recent Cutis article by Golda et al,1 “Intraoperative Electrosurgical Smoke During Outpatient Surgery: A Survey of Dermatologic Surgeon and Staff Preferences.” We applaud the growing interest in the topic of dermatologist safety, as there are currently no established guidelines for precautions while performing surgical procedures. In 2018 we conducted a comprehensive review2 to characterize the specific risks, hazard reduction strategies available, and current use of surgical smoke safety techniques during surgery among dermatologists, and ultimately recommend guidance based on the current available evidence. To conduct this review, we collected data from 45 manuscripts in the dermatology, surgery, infectious disease, obstetrics, and cancer biology literature. Herein, we summarize key findings.2
Dermatologic surgeons, residents, staff, and patients are exposed to many infectious, inhalational, chemical, and mutagenic hazards when performing procedures that liberate smoke and plume. These risks are commonplace; however, they are particularly notable during ablative laser and laser hair removal procedures, which produce a heavy plume (averaging >100,000 particles/cm3). Brief periods of heavy plume exposure also are commonplace during electrosurgery.
Infectious particles in surgical plume have been extensively studied, and viral transmission has been demonstrated in animal studies. Human papillomavirus transmission appears to be the most prevalent risk. Surgical smoke has been shown to cause acute and chronic inhalational injury in rat and sheep studies.3-6
Additionally, chemicals with carcinogenic potential are present in surgical smoke and have been described.7,8 Chemicals in the greatest quantity include hydrocarbons, nitriles, fatty acids, and phenols. Although there have been no human studies on smoke carcinogenesis to date, surgical smoke has been shown to have carcinogenic properties in vitro.
Given these risks—both evidence based and theoretical—we believe that diligent hazard reduction strategies should be employed whenever possible. Surgical masks and high-efficiency particulate air respirators, such as N95 respirator masks, have been well studied and do provide smoke protection. High-efficiency particulate air masks can be worn when possible, especially during procedures that produce heavy plume, though surgical masks are capable of filtering most of the noxious chemicals in surgical smoke. It should be noted that proper fit with minimal air leak is the most important aspect of overall performance.
Smoke evacuators provide another level of protection. The physician should consider the evacuator’s filtration efficiency, capture velocity, and suction strength when evaluating overall performance. Furthermore, the smoke collection tip should be within 2 in of the surgical field to maximize efficacy. Maintenance for smoke evacuation systems should include regular (as defined by manufacturer instructions) flushing of the smoke evacuator lines.
Despite the risks of surgical smoke and the available options of minimizing these risks, the hazards of surgical smoke and the importance of protection are likely underemphasized. Many dermatologic surgeons do not use surgical masks or smoke evacuators in routine practice, according to several survey studies.9-11
It is important for the dermatologic community to consider effective ways of spreading awareness. We propose that surgical smoke safety be taught early in residency training. Additionally, smoke safety can be implemented into certification examinations. Access to masks and smoke evacuation devices are an important part of dermatology training. Accreditation Council for Graduate Medical Education funds should be appropriated to provide for such resources.
Finally, and perhaps most importantly, continued awareness should be established in the dermatology community via standardized guidelines and periodic updates in the dermatology literature and lectures at local and national conferences. Not until these strategies are implemented will surgical smoke protection be viewed as a necessary and important component of routine practice when performing dermatologic surgical procedures.
- Golda N, Merrill B, Neill B. Intraoperative electrosurgical smoke during outpatient surgery: a survey of dermatologic surgeon and staff preferences. Cutis. 2019;104:120-124.
- Georgesen C, Lipner SR. Surgical smoke: risk assessment and mitigation strategies. J Am Acad Dermatol. 2018;79:746-755.
- Wenig BL, Stenson KM, Wenig BM, et al. Effects of plume produced by the Nd:YAG laser and electrocautery on the respiratory system. Lasers Surg Med. 1993;13:242-245.
- Baggish MS, Elbakry M. The effects of laser smoke on the lungs of rats. Am J Obstet Gynecol. 1987;156:1260-1265.
- Baggish MS, Baltoyannis P, Sze E. Protection of the rat lung from the harmful effects of laser smoke. Lasers Surg Med. 1988;8:248-253.
- Freitag L, Chapman GA, Sielczak M, et al. Laser smoke effect on the bronchial system. Lasers Surg Med. 1987;7:283-288.
- Barrett WL, Garber SM. Surgical smoke: a review of the literature. Is this just a lot of hot air? Surg Endosc. 2003;17:979-987.
- Hensman C, Baty D, Willis RG, et al. Chemical composition of smoke produced by high-frequency electrosurgery in a closed gaseous environment. Surg Endosc. 1998;12:1017-1019.
- Edwards BE, Reiman RE. Results of a survey on current surgical smoke control practices. AORN J. 2008;87:739-749.
- Oganesyan G, Eimpunth S, Kim SS, et al. Surgical smoke in dermatologic surgery. Dermatol Surg. 2014;40:1373-1377.
- Chapman LW, Korta DZ, Lee PK, et al. Awareness of surgical smoke risks and assessment of safety practices during electrosurgery among US dermatology residents. JAMA Dermatol. 2017;153:467-468.
To the Editor:
We read with great interest the recent Cutis article by Golda et al,1 “Intraoperative Electrosurgical Smoke During Outpatient Surgery: A Survey of Dermatologic Surgeon and Staff Preferences.” We applaud the growing interest in the topic of dermatologist safety, as there are currently no established guidelines for precautions while performing surgical procedures. In 2018 we conducted a comprehensive review2 to characterize the specific risks, hazard reduction strategies available, and current use of surgical smoke safety techniques during surgery among dermatologists, and ultimately recommend guidance based on the current available evidence. To conduct this review, we collected data from 45 manuscripts in the dermatology, surgery, infectious disease, obstetrics, and cancer biology literature. Herein, we summarize key findings.2
Dermatologic surgeons, residents, staff, and patients are exposed to many infectious, inhalational, chemical, and mutagenic hazards when performing procedures that liberate smoke and plume. These risks are commonplace; however, they are particularly notable during ablative laser and laser hair removal procedures, which produce a heavy plume (averaging >100,000 particles/cm3). Brief periods of heavy plume exposure also are commonplace during electrosurgery.
Infectious particles in surgical plume have been extensively studied, and viral transmission has been demonstrated in animal studies. Human papillomavirus transmission appears to be the most prevalent risk. Surgical smoke has been shown to cause acute and chronic inhalational injury in rat and sheep studies.3-6
Additionally, chemicals with carcinogenic potential are present in surgical smoke and have been described.7,8 Chemicals in the greatest quantity include hydrocarbons, nitriles, fatty acids, and phenols. Although there have been no human studies on smoke carcinogenesis to date, surgical smoke has been shown to have carcinogenic properties in vitro.
Given these risks—both evidence based and theoretical—we believe that diligent hazard reduction strategies should be employed whenever possible. Surgical masks and high-efficiency particulate air respirators, such as N95 respirator masks, have been well studied and do provide smoke protection. High-efficiency particulate air masks can be worn when possible, especially during procedures that produce heavy plume, though surgical masks are capable of filtering most of the noxious chemicals in surgical smoke. It should be noted that proper fit with minimal air leak is the most important aspect of overall performance.
Smoke evacuators provide another level of protection. The physician should consider the evacuator’s filtration efficiency, capture velocity, and suction strength when evaluating overall performance. Furthermore, the smoke collection tip should be within 2 in of the surgical field to maximize efficacy. Maintenance for smoke evacuation systems should include regular (as defined by manufacturer instructions) flushing of the smoke evacuator lines.
Despite the risks of surgical smoke and the available options of minimizing these risks, the hazards of surgical smoke and the importance of protection are likely underemphasized. Many dermatologic surgeons do not use surgical masks or smoke evacuators in routine practice, according to several survey studies.9-11
It is important for the dermatologic community to consider effective ways of spreading awareness. We propose that surgical smoke safety be taught early in residency training. Additionally, smoke safety can be implemented into certification examinations. Access to masks and smoke evacuation devices are an important part of dermatology training. Accreditation Council for Graduate Medical Education funds should be appropriated to provide for such resources.
Finally, and perhaps most importantly, continued awareness should be established in the dermatology community via standardized guidelines and periodic updates in the dermatology literature and lectures at local and national conferences. Not until these strategies are implemented will surgical smoke protection be viewed as a necessary and important component of routine practice when performing dermatologic surgical procedures.
To the Editor:
We read with great interest the recent Cutis article by Golda et al,1 “Intraoperative Electrosurgical Smoke During Outpatient Surgery: A Survey of Dermatologic Surgeon and Staff Preferences.” We applaud the growing interest in the topic of dermatologist safety, as there are currently no established guidelines for precautions while performing surgical procedures. In 2018 we conducted a comprehensive review2 to characterize the specific risks, hazard reduction strategies available, and current use of surgical smoke safety techniques during surgery among dermatologists, and ultimately recommend guidance based on the current available evidence. To conduct this review, we collected data from 45 manuscripts in the dermatology, surgery, infectious disease, obstetrics, and cancer biology literature. Herein, we summarize key findings.2
Dermatologic surgeons, residents, staff, and patients are exposed to many infectious, inhalational, chemical, and mutagenic hazards when performing procedures that liberate smoke and plume. These risks are commonplace; however, they are particularly notable during ablative laser and laser hair removal procedures, which produce a heavy plume (averaging >100,000 particles/cm3). Brief periods of heavy plume exposure also are commonplace during electrosurgery.
Infectious particles in surgical plume have been extensively studied, and viral transmission has been demonstrated in animal studies. Human papillomavirus transmission appears to be the most prevalent risk. Surgical smoke has been shown to cause acute and chronic inhalational injury in rat and sheep studies.3-6
Additionally, chemicals with carcinogenic potential are present in surgical smoke and have been described.7,8 Chemicals in the greatest quantity include hydrocarbons, nitriles, fatty acids, and phenols. Although there have been no human studies on smoke carcinogenesis to date, surgical smoke has been shown to have carcinogenic properties in vitro.
Given these risks—both evidence based and theoretical—we believe that diligent hazard reduction strategies should be employed whenever possible. Surgical masks and high-efficiency particulate air respirators, such as N95 respirator masks, have been well studied and do provide smoke protection. High-efficiency particulate air masks can be worn when possible, especially during procedures that produce heavy plume, though surgical masks are capable of filtering most of the noxious chemicals in surgical smoke. It should be noted that proper fit with minimal air leak is the most important aspect of overall performance.
Smoke evacuators provide another level of protection. The physician should consider the evacuator’s filtration efficiency, capture velocity, and suction strength when evaluating overall performance. Furthermore, the smoke collection tip should be within 2 in of the surgical field to maximize efficacy. Maintenance for smoke evacuation systems should include regular (as defined by manufacturer instructions) flushing of the smoke evacuator lines.
Despite the risks of surgical smoke and the available options of minimizing these risks, the hazards of surgical smoke and the importance of protection are likely underemphasized. Many dermatologic surgeons do not use surgical masks or smoke evacuators in routine practice, according to several survey studies.9-11
It is important for the dermatologic community to consider effective ways of spreading awareness. We propose that surgical smoke safety be taught early in residency training. Additionally, smoke safety can be implemented into certification examinations. Access to masks and smoke evacuation devices are an important part of dermatology training. Accreditation Council for Graduate Medical Education funds should be appropriated to provide for such resources.
Finally, and perhaps most importantly, continued awareness should be established in the dermatology community via standardized guidelines and periodic updates in the dermatology literature and lectures at local and national conferences. Not until these strategies are implemented will surgical smoke protection be viewed as a necessary and important component of routine practice when performing dermatologic surgical procedures.
- Golda N, Merrill B, Neill B. Intraoperative electrosurgical smoke during outpatient surgery: a survey of dermatologic surgeon and staff preferences. Cutis. 2019;104:120-124.
- Georgesen C, Lipner SR. Surgical smoke: risk assessment and mitigation strategies. J Am Acad Dermatol. 2018;79:746-755.
- Wenig BL, Stenson KM, Wenig BM, et al. Effects of plume produced by the Nd:YAG laser and electrocautery on the respiratory system. Lasers Surg Med. 1993;13:242-245.
- Baggish MS, Elbakry M. The effects of laser smoke on the lungs of rats. Am J Obstet Gynecol. 1987;156:1260-1265.
- Baggish MS, Baltoyannis P, Sze E. Protection of the rat lung from the harmful effects of laser smoke. Lasers Surg Med. 1988;8:248-253.
- Freitag L, Chapman GA, Sielczak M, et al. Laser smoke effect on the bronchial system. Lasers Surg Med. 1987;7:283-288.
- Barrett WL, Garber SM. Surgical smoke: a review of the literature. Is this just a lot of hot air? Surg Endosc. 2003;17:979-987.
- Hensman C, Baty D, Willis RG, et al. Chemical composition of smoke produced by high-frequency electrosurgery in a closed gaseous environment. Surg Endosc. 1998;12:1017-1019.
- Edwards BE, Reiman RE. Results of a survey on current surgical smoke control practices. AORN J. 2008;87:739-749.
- Oganesyan G, Eimpunth S, Kim SS, et al. Surgical smoke in dermatologic surgery. Dermatol Surg. 2014;40:1373-1377.
- Chapman LW, Korta DZ, Lee PK, et al. Awareness of surgical smoke risks and assessment of safety practices during electrosurgery among US dermatology residents. JAMA Dermatol. 2017;153:467-468.
- Golda N, Merrill B, Neill B. Intraoperative electrosurgical smoke during outpatient surgery: a survey of dermatologic surgeon and staff preferences. Cutis. 2019;104:120-124.
- Georgesen C, Lipner SR. Surgical smoke: risk assessment and mitigation strategies. J Am Acad Dermatol. 2018;79:746-755.
- Wenig BL, Stenson KM, Wenig BM, et al. Effects of plume produced by the Nd:YAG laser and electrocautery on the respiratory system. Lasers Surg Med. 1993;13:242-245.
- Baggish MS, Elbakry M. The effects of laser smoke on the lungs of rats. Am J Obstet Gynecol. 1987;156:1260-1265.
- Baggish MS, Baltoyannis P, Sze E. Protection of the rat lung from the harmful effects of laser smoke. Lasers Surg Med. 1988;8:248-253.
- Freitag L, Chapman GA, Sielczak M, et al. Laser smoke effect on the bronchial system. Lasers Surg Med. 1987;7:283-288.
- Barrett WL, Garber SM. Surgical smoke: a review of the literature. Is this just a lot of hot air? Surg Endosc. 2003;17:979-987.
- Hensman C, Baty D, Willis RG, et al. Chemical composition of smoke produced by high-frequency electrosurgery in a closed gaseous environment. Surg Endosc. 1998;12:1017-1019.
- Edwards BE, Reiman RE. Results of a survey on current surgical smoke control practices. AORN J. 2008;87:739-749.
- Oganesyan G, Eimpunth S, Kim SS, et al. Surgical smoke in dermatologic surgery. Dermatol Surg. 2014;40:1373-1377.
- Chapman LW, Korta DZ, Lee PK, et al. Awareness of surgical smoke risks and assessment of safety practices during electrosurgery among US dermatology residents. JAMA Dermatol. 2017;153:467-468.
FDA proposes new breast implant labeling with a boxed warning
Breast implants sold in the United States may soon require a boxed warning in their label, along with other label changes proposed by the Food and Drug Administration aimed at better informing prospective patients and clinicians of the potential risks from breast implants.
Other elements of the proposed labeling changes include creation of a patient-decision checklist, new recommendations for follow-up imaging to monitor for implant rupture, inclusion of detailed and understandable information about materials in the device, and provision of a device card to each patient with details on the specific implant they received.
These labeling changes all stemmed from a breast implant hearing held by the agency’s General and Plastic Surgery Devices Panel in March 2019, according to the draft guidance document officially released by the FDA on Oct. 24.
The proposed labeling changes were generally welcomed by patient advocates and by clinicians as a reasonable response to the concerns discussed at the March hearing. In an earlier move to address issues brought up at the hearing, the FDA in July arranged for a recall for certain Allergan models of textured breast implants because of their link with the development of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).
The boxed warning proposed by the FDA would highlight four specific facts that patients, physicians, and surgeons should know about breast implants: They are not considered lifetime devices, the chance of developing complications from implants increases over time, some complications require additional surgery, and placement of breast implants has been associated with development of BIA-ALCL and may also be associated with certain systemic symptoms.
The FDA also proposed four other notable labeling changes:
- Creation of a patient-decision checklist to better systematize the informed consent process and make sure that certain aspects of breast implant placement are clearly brought to patients’ attention. The FDA proposed that patients sign their checklist attesting to having read and understood the information and that patients receive a take-home copy for their future reference. Proposed elements of the checklist include situations to not use breast implants; considerations for successful implant recipients; the risks of breast implant surgery; the importance of appropriate physician education, training, and experience; the risk for developing BIA-ALCL or systemic symptoms; and discussion of options other than breast implants.
- A new scheme for systematically and serially using imaging to screen for implant rupture that designates for the first time that ultrasound is an acceptable alternative to MRI and relies on a schedule by which either method initially screens the implant 5-6 years post operatively and then every 2 years thereafter.
- Detailed and understandable information about each material component of the implant with further information on possible adverse health effects of these compounds.
- A device card that patients should receive after their surgery with the implant’s name, serial number, and other identifiers; the boxed warning information; and a web link for accessing more up-to-date information.
The patient group Breast Implant Victim Advocacy praised the draft guidance. “The March Advisory Committee meeting seems to have prompted a shift by the FDA, surgeons, and industry,” said Jamee Cook, cofounder of the group. “We are definitely seeing a change in patient engagement. The FDA has been cooperating with patients and listening to our concerns. We still have a long way to go in raising public awareness of breast implant issues, but progress over the past 1-2 years has been amazing.”
Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, gave the draft guidance a mixed review. “The FDA’s draft includes the types of information that we had proposed to the FDA in recent months in our work with patient advocates and plastic surgeons,” she said. “However, it is not as informative as it should be in describing well-designed studies indicating a risk of systemic illnesses. Patients deserve to make better-informed decisions in the future than most women considering breast implants have been able to make” in the past.
Patricia McGuire, MD, a St. Louis plastic surgeon who specializes in breast surgery and has studied breast implant illness, declared the guidance to be “reasonable.”
“I think the changes address the concerns expressed by patients during the [March] hearing; I agree with everything the FDA proposed in the guidance document,” Dr. McGuire said. “The boxed warning is reasonable and needs to be part of the informed consent process. I also agree with the changes in screening implants postoperatively. Most patients do not get MRI examinations. High-resolution ultrasound is more convenient and cost effective.”
The boxed warning was rated as “reasonably strong” and “the most serious step the FDA can take short of taking a device off the market,” but in the case of breast implants, a wider recall of textured implants than what the FDA arranged last July would be even more appropriate, commented Sidney M. Wolfe, MD, founder and senior adviser to Public Citizen. He also faulted the agency for not taking quicker action in mandating inclusion of the proposed boxed warning.
Issuing the labeling changes as draft guidance “is a ministep forward,” but also a process that “guarantees delay” and “creeps along at a dangerously slow pace,” Dr. Wolfe said. “The FDA is delaying what should be inevitable. The agency could put the boxed warning in place right now if they had the guts to do it.”
Dr. McGuire has been a consultant to Allergan, Establishment Labs, and Hans Biomed. Ms. Cook, Dr. Zuckerman, and Dr. Wolfe reported having no commercial disclosures.
Breast implants sold in the United States may soon require a boxed warning in their label, along with other label changes proposed by the Food and Drug Administration aimed at better informing prospective patients and clinicians of the potential risks from breast implants.
Other elements of the proposed labeling changes include creation of a patient-decision checklist, new recommendations for follow-up imaging to monitor for implant rupture, inclusion of detailed and understandable information about materials in the device, and provision of a device card to each patient with details on the specific implant they received.
These labeling changes all stemmed from a breast implant hearing held by the agency’s General and Plastic Surgery Devices Panel in March 2019, according to the draft guidance document officially released by the FDA on Oct. 24.
The proposed labeling changes were generally welcomed by patient advocates and by clinicians as a reasonable response to the concerns discussed at the March hearing. In an earlier move to address issues brought up at the hearing, the FDA in July arranged for a recall for certain Allergan models of textured breast implants because of their link with the development of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).
The boxed warning proposed by the FDA would highlight four specific facts that patients, physicians, and surgeons should know about breast implants: They are not considered lifetime devices, the chance of developing complications from implants increases over time, some complications require additional surgery, and placement of breast implants has been associated with development of BIA-ALCL and may also be associated with certain systemic symptoms.
The FDA also proposed four other notable labeling changes:
- Creation of a patient-decision checklist to better systematize the informed consent process and make sure that certain aspects of breast implant placement are clearly brought to patients’ attention. The FDA proposed that patients sign their checklist attesting to having read and understood the information and that patients receive a take-home copy for their future reference. Proposed elements of the checklist include situations to not use breast implants; considerations for successful implant recipients; the risks of breast implant surgery; the importance of appropriate physician education, training, and experience; the risk for developing BIA-ALCL or systemic symptoms; and discussion of options other than breast implants.
- A new scheme for systematically and serially using imaging to screen for implant rupture that designates for the first time that ultrasound is an acceptable alternative to MRI and relies on a schedule by which either method initially screens the implant 5-6 years post operatively and then every 2 years thereafter.
- Detailed and understandable information about each material component of the implant with further information on possible adverse health effects of these compounds.
- A device card that patients should receive after their surgery with the implant’s name, serial number, and other identifiers; the boxed warning information; and a web link for accessing more up-to-date information.
The patient group Breast Implant Victim Advocacy praised the draft guidance. “The March Advisory Committee meeting seems to have prompted a shift by the FDA, surgeons, and industry,” said Jamee Cook, cofounder of the group. “We are definitely seeing a change in patient engagement. The FDA has been cooperating with patients and listening to our concerns. We still have a long way to go in raising public awareness of breast implant issues, but progress over the past 1-2 years has been amazing.”
Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, gave the draft guidance a mixed review. “The FDA’s draft includes the types of information that we had proposed to the FDA in recent months in our work with patient advocates and plastic surgeons,” she said. “However, it is not as informative as it should be in describing well-designed studies indicating a risk of systemic illnesses. Patients deserve to make better-informed decisions in the future than most women considering breast implants have been able to make” in the past.
Patricia McGuire, MD, a St. Louis plastic surgeon who specializes in breast surgery and has studied breast implant illness, declared the guidance to be “reasonable.”
“I think the changes address the concerns expressed by patients during the [March] hearing; I agree with everything the FDA proposed in the guidance document,” Dr. McGuire said. “The boxed warning is reasonable and needs to be part of the informed consent process. I also agree with the changes in screening implants postoperatively. Most patients do not get MRI examinations. High-resolution ultrasound is more convenient and cost effective.”
The boxed warning was rated as “reasonably strong” and “the most serious step the FDA can take short of taking a device off the market,” but in the case of breast implants, a wider recall of textured implants than what the FDA arranged last July would be even more appropriate, commented Sidney M. Wolfe, MD, founder and senior adviser to Public Citizen. He also faulted the agency for not taking quicker action in mandating inclusion of the proposed boxed warning.
Issuing the labeling changes as draft guidance “is a ministep forward,” but also a process that “guarantees delay” and “creeps along at a dangerously slow pace,” Dr. Wolfe said. “The FDA is delaying what should be inevitable. The agency could put the boxed warning in place right now if they had the guts to do it.”
Dr. McGuire has been a consultant to Allergan, Establishment Labs, and Hans Biomed. Ms. Cook, Dr. Zuckerman, and Dr. Wolfe reported having no commercial disclosures.
Breast implants sold in the United States may soon require a boxed warning in their label, along with other label changes proposed by the Food and Drug Administration aimed at better informing prospective patients and clinicians of the potential risks from breast implants.
Other elements of the proposed labeling changes include creation of a patient-decision checklist, new recommendations for follow-up imaging to monitor for implant rupture, inclusion of detailed and understandable information about materials in the device, and provision of a device card to each patient with details on the specific implant they received.
These labeling changes all stemmed from a breast implant hearing held by the agency’s General and Plastic Surgery Devices Panel in March 2019, according to the draft guidance document officially released by the FDA on Oct. 24.
The proposed labeling changes were generally welcomed by patient advocates and by clinicians as a reasonable response to the concerns discussed at the March hearing. In an earlier move to address issues brought up at the hearing, the FDA in July arranged for a recall for certain Allergan models of textured breast implants because of their link with the development of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).
The boxed warning proposed by the FDA would highlight four specific facts that patients, physicians, and surgeons should know about breast implants: They are not considered lifetime devices, the chance of developing complications from implants increases over time, some complications require additional surgery, and placement of breast implants has been associated with development of BIA-ALCL and may also be associated with certain systemic symptoms.
The FDA also proposed four other notable labeling changes:
- Creation of a patient-decision checklist to better systematize the informed consent process and make sure that certain aspects of breast implant placement are clearly brought to patients’ attention. The FDA proposed that patients sign their checklist attesting to having read and understood the information and that patients receive a take-home copy for their future reference. Proposed elements of the checklist include situations to not use breast implants; considerations for successful implant recipients; the risks of breast implant surgery; the importance of appropriate physician education, training, and experience; the risk for developing BIA-ALCL or systemic symptoms; and discussion of options other than breast implants.
- A new scheme for systematically and serially using imaging to screen for implant rupture that designates for the first time that ultrasound is an acceptable alternative to MRI and relies on a schedule by which either method initially screens the implant 5-6 years post operatively and then every 2 years thereafter.
- Detailed and understandable information about each material component of the implant with further information on possible adverse health effects of these compounds.
- A device card that patients should receive after their surgery with the implant’s name, serial number, and other identifiers; the boxed warning information; and a web link for accessing more up-to-date information.
The patient group Breast Implant Victim Advocacy praised the draft guidance. “The March Advisory Committee meeting seems to have prompted a shift by the FDA, surgeons, and industry,” said Jamee Cook, cofounder of the group. “We are definitely seeing a change in patient engagement. The FDA has been cooperating with patients and listening to our concerns. We still have a long way to go in raising public awareness of breast implant issues, but progress over the past 1-2 years has been amazing.”
Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, gave the draft guidance a mixed review. “The FDA’s draft includes the types of information that we had proposed to the FDA in recent months in our work with patient advocates and plastic surgeons,” she said. “However, it is not as informative as it should be in describing well-designed studies indicating a risk of systemic illnesses. Patients deserve to make better-informed decisions in the future than most women considering breast implants have been able to make” in the past.
Patricia McGuire, MD, a St. Louis plastic surgeon who specializes in breast surgery and has studied breast implant illness, declared the guidance to be “reasonable.”
“I think the changes address the concerns expressed by patients during the [March] hearing; I agree with everything the FDA proposed in the guidance document,” Dr. McGuire said. “The boxed warning is reasonable and needs to be part of the informed consent process. I also agree with the changes in screening implants postoperatively. Most patients do not get MRI examinations. High-resolution ultrasound is more convenient and cost effective.”
The boxed warning was rated as “reasonably strong” and “the most serious step the FDA can take short of taking a device off the market,” but in the case of breast implants, a wider recall of textured implants than what the FDA arranged last July would be even more appropriate, commented Sidney M. Wolfe, MD, founder and senior adviser to Public Citizen. He also faulted the agency for not taking quicker action in mandating inclusion of the proposed boxed warning.
Issuing the labeling changes as draft guidance “is a ministep forward,” but also a process that “guarantees delay” and “creeps along at a dangerously slow pace,” Dr. Wolfe said. “The FDA is delaying what should be inevitable. The agency could put the boxed warning in place right now if they had the guts to do it.”
Dr. McGuire has been a consultant to Allergan, Establishment Labs, and Hans Biomed. Ms. Cook, Dr. Zuckerman, and Dr. Wolfe reported having no commercial disclosures.
Acoustic pulse boosts laser tattoo removal
In tattoo removal, the impact of laser treatments in single office visits is limited because of the laser’s effects on the skin. Now, a new study suggests that a
“As a result,” the authors of the study wrote, “a lower total number of office visits will likely be required for complete tattoo removal leading to improved convenience and efficiency as well as increased satisfaction for both patients and clinicians.” The study, led by cosmetic surgeon Michael S. Kaminer, MD, of SkinCare Physicians in Chestnut Hill, Mass., appeared in Lasers in Surgery and Medicine.
In the study, he and his coauthors pointed out that tattoos are most frequently removed with short-pulse high-fluence lasers, such as a 1064-nm Nd:YAG Q‐switched (QS) laser. However, “the QS laser has a limited ability to affect the tattoo ink pigment particles in each treatment session due to shielding of the pigment particles caused by both the agglomeration of the pigment particles and laser‐induced epidermal and dermal vacuoles known as ‘whitening.’ ” Therefore, “use of the QS laser often requires 10 or more single‐pass office sessions to achieve acceptable fading results.”
The study evaluated whether the use of a rapid acoustic pulse (RAP) device could reduce the whitening effect by clearing vacuoles and make it possible to increase the number of potential laser passes. In the single-center, prospective trial, they treated 32 black-ink tattoos in 21 patients, dividing the tattoos into zones and treating them differently: One zone received at least three consecutive laser passes alternating with a minute of treatment with the RAP device, one received single-pass laser treatment, and one received no treatment.
Reviewers assessed the tattoos for fading at 12 weeks. Average percent fading was higher in the laser/RAP group, compared with the laser-only group (44% and 25%, respectively, P less than .01). The percentages of tattoos with more than 50% fading (38% vs. 9%, P less than .01) and more than 75% fading (22% vs. 3%, P less than .05) were also higher in the laser/RAP group, compared with the laser-only group.
“Further clinical studies will be performed to investigate the broader applicability of the RAP device as an accessory device to reduce the number of laser tattoo removal sessions for other tattoo ink colors in a broader range of skin types,” the researchers commented, noting that the study included patients with Fitzpatrick skin types I-III.
The study was funded by Soliton, which provided the equipment. One of the six authors is an employee of the company The other authors reported no relevant disclosures.
SOURCE: Kaminer MS et al. Lasers Surg Med. 2019 Sep 19. doi: 10.1002/lsm.23163.
In tattoo removal, the impact of laser treatments in single office visits is limited because of the laser’s effects on the skin. Now, a new study suggests that a
“As a result,” the authors of the study wrote, “a lower total number of office visits will likely be required for complete tattoo removal leading to improved convenience and efficiency as well as increased satisfaction for both patients and clinicians.” The study, led by cosmetic surgeon Michael S. Kaminer, MD, of SkinCare Physicians in Chestnut Hill, Mass., appeared in Lasers in Surgery and Medicine.
In the study, he and his coauthors pointed out that tattoos are most frequently removed with short-pulse high-fluence lasers, such as a 1064-nm Nd:YAG Q‐switched (QS) laser. However, “the QS laser has a limited ability to affect the tattoo ink pigment particles in each treatment session due to shielding of the pigment particles caused by both the agglomeration of the pigment particles and laser‐induced epidermal and dermal vacuoles known as ‘whitening.’ ” Therefore, “use of the QS laser often requires 10 or more single‐pass office sessions to achieve acceptable fading results.”
The study evaluated whether the use of a rapid acoustic pulse (RAP) device could reduce the whitening effect by clearing vacuoles and make it possible to increase the number of potential laser passes. In the single-center, prospective trial, they treated 32 black-ink tattoos in 21 patients, dividing the tattoos into zones and treating them differently: One zone received at least three consecutive laser passes alternating with a minute of treatment with the RAP device, one received single-pass laser treatment, and one received no treatment.
Reviewers assessed the tattoos for fading at 12 weeks. Average percent fading was higher in the laser/RAP group, compared with the laser-only group (44% and 25%, respectively, P less than .01). The percentages of tattoos with more than 50% fading (38% vs. 9%, P less than .01) and more than 75% fading (22% vs. 3%, P less than .05) were also higher in the laser/RAP group, compared with the laser-only group.
“Further clinical studies will be performed to investigate the broader applicability of the RAP device as an accessory device to reduce the number of laser tattoo removal sessions for other tattoo ink colors in a broader range of skin types,” the researchers commented, noting that the study included patients with Fitzpatrick skin types I-III.
The study was funded by Soliton, which provided the equipment. One of the six authors is an employee of the company The other authors reported no relevant disclosures.
SOURCE: Kaminer MS et al. Lasers Surg Med. 2019 Sep 19. doi: 10.1002/lsm.23163.
In tattoo removal, the impact of laser treatments in single office visits is limited because of the laser’s effects on the skin. Now, a new study suggests that a
“As a result,” the authors of the study wrote, “a lower total number of office visits will likely be required for complete tattoo removal leading to improved convenience and efficiency as well as increased satisfaction for both patients and clinicians.” The study, led by cosmetic surgeon Michael S. Kaminer, MD, of SkinCare Physicians in Chestnut Hill, Mass., appeared in Lasers in Surgery and Medicine.
In the study, he and his coauthors pointed out that tattoos are most frequently removed with short-pulse high-fluence lasers, such as a 1064-nm Nd:YAG Q‐switched (QS) laser. However, “the QS laser has a limited ability to affect the tattoo ink pigment particles in each treatment session due to shielding of the pigment particles caused by both the agglomeration of the pigment particles and laser‐induced epidermal and dermal vacuoles known as ‘whitening.’ ” Therefore, “use of the QS laser often requires 10 or more single‐pass office sessions to achieve acceptable fading results.”
The study evaluated whether the use of a rapid acoustic pulse (RAP) device could reduce the whitening effect by clearing vacuoles and make it possible to increase the number of potential laser passes. In the single-center, prospective trial, they treated 32 black-ink tattoos in 21 patients, dividing the tattoos into zones and treating them differently: One zone received at least three consecutive laser passes alternating with a minute of treatment with the RAP device, one received single-pass laser treatment, and one received no treatment.
Reviewers assessed the tattoos for fading at 12 weeks. Average percent fading was higher in the laser/RAP group, compared with the laser-only group (44% and 25%, respectively, P less than .01). The percentages of tattoos with more than 50% fading (38% vs. 9%, P less than .01) and more than 75% fading (22% vs. 3%, P less than .05) were also higher in the laser/RAP group, compared with the laser-only group.
“Further clinical studies will be performed to investigate the broader applicability of the RAP device as an accessory device to reduce the number of laser tattoo removal sessions for other tattoo ink colors in a broader range of skin types,” the researchers commented, noting that the study included patients with Fitzpatrick skin types I-III.
The study was funded by Soliton, which provided the equipment. One of the six authors is an employee of the company The other authors reported no relevant disclosures.
SOURCE: Kaminer MS et al. Lasers Surg Med. 2019 Sep 19. doi: 10.1002/lsm.23163.
FROM LASERS IN SURGERY AND MEDICINE
Online resources influencing cosmetic treatment choices
Online resources are affecting most consumers’ selections of cosmetic providers, and social media are now a top-three influence on cosmetic procedure choices and skin care purchases, according to a new survey from the American Society for Dermatologic Surgery.
Almost 70% of respondents said that their use of rate and review websites had an impact on the choice of provider for cosmetic procedures: WebMD was the site most often visited, followed by Facebook, physician websites, and Yelp, the ASDS said based on its annual consumer survey.
For 43% of consumers, the decision to schedule an appointment was influenced by a provider’s social media presence, and 41% of patients said that they follow their current or potential provider on social media, the ASDS said.
“Online resources and social media platforms are clearly influencing consumers’ behavior and perception of skin health,” ASDS President Murad Alam, MD, MBA, chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, Chicago, said in a written statement.
Dermatologists, however, remain the leading influence on the decision to have a cosmetic procedure – named as a resource by 34% of respondents, who could select more than one possibility from a list of 15 – but social media moved ahead of primary care physicians into third place (24%), just behind friends (30%), the survey showed. Dermatologists, on the other hand, had polled at 50%-55% for the previous 5 years.
The dermatologists’ lead remained stronger as the top influencer for skin care purchases, selected by 45% of respondents, compared with 32% for friends and 28% for social media. In this category there were 14 factors from which respondents could choose. As for the cost of those skin care products, 48% of consumers spent $1-$50 a month, 31% said that they spent $51-$100 a month, and 12% reported spending $101-$150 a month, the ASDS said.
The society received 3,645 responses to the 2019 Consumer Survey on Cosmetic Dermatologic Procedures, which was conducted online from July 30 to Aug. 27 by Survata.
Online resources are affecting most consumers’ selections of cosmetic providers, and social media are now a top-three influence on cosmetic procedure choices and skin care purchases, according to a new survey from the American Society for Dermatologic Surgery.
Almost 70% of respondents said that their use of rate and review websites had an impact on the choice of provider for cosmetic procedures: WebMD was the site most often visited, followed by Facebook, physician websites, and Yelp, the ASDS said based on its annual consumer survey.
For 43% of consumers, the decision to schedule an appointment was influenced by a provider’s social media presence, and 41% of patients said that they follow their current or potential provider on social media, the ASDS said.
“Online resources and social media platforms are clearly influencing consumers’ behavior and perception of skin health,” ASDS President Murad Alam, MD, MBA, chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, Chicago, said in a written statement.
Dermatologists, however, remain the leading influence on the decision to have a cosmetic procedure – named as a resource by 34% of respondents, who could select more than one possibility from a list of 15 – but social media moved ahead of primary care physicians into third place (24%), just behind friends (30%), the survey showed. Dermatologists, on the other hand, had polled at 50%-55% for the previous 5 years.
The dermatologists’ lead remained stronger as the top influencer for skin care purchases, selected by 45% of respondents, compared with 32% for friends and 28% for social media. In this category there were 14 factors from which respondents could choose. As for the cost of those skin care products, 48% of consumers spent $1-$50 a month, 31% said that they spent $51-$100 a month, and 12% reported spending $101-$150 a month, the ASDS said.
The society received 3,645 responses to the 2019 Consumer Survey on Cosmetic Dermatologic Procedures, which was conducted online from July 30 to Aug. 27 by Survata.
Online resources are affecting most consumers’ selections of cosmetic providers, and social media are now a top-three influence on cosmetic procedure choices and skin care purchases, according to a new survey from the American Society for Dermatologic Surgery.
Almost 70% of respondents said that their use of rate and review websites had an impact on the choice of provider for cosmetic procedures: WebMD was the site most often visited, followed by Facebook, physician websites, and Yelp, the ASDS said based on its annual consumer survey.
For 43% of consumers, the decision to schedule an appointment was influenced by a provider’s social media presence, and 41% of patients said that they follow their current or potential provider on social media, the ASDS said.
“Online resources and social media platforms are clearly influencing consumers’ behavior and perception of skin health,” ASDS President Murad Alam, MD, MBA, chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, Chicago, said in a written statement.
Dermatologists, however, remain the leading influence on the decision to have a cosmetic procedure – named as a resource by 34% of respondents, who could select more than one possibility from a list of 15 – but social media moved ahead of primary care physicians into third place (24%), just behind friends (30%), the survey showed. Dermatologists, on the other hand, had polled at 50%-55% for the previous 5 years.
The dermatologists’ lead remained stronger as the top influencer for skin care purchases, selected by 45% of respondents, compared with 32% for friends and 28% for social media. In this category there were 14 factors from which respondents could choose. As for the cost of those skin care products, 48% of consumers spent $1-$50 a month, 31% said that they spent $51-$100 a month, and 12% reported spending $101-$150 a month, the ASDS said.
The society received 3,645 responses to the 2019 Consumer Survey on Cosmetic Dermatologic Procedures, which was conducted online from July 30 to Aug. 27 by Survata.