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Nevus of Ota: Does the 1064-nm Q-switched Nd:YAG laser work in Black patients?
SAN DIEGO – Using a , results from a small single-center study showed.
Nevus of Ota is a benign melanocytic lesion that presents as a unilateral blue-gray to blue-brown facial patch favoring the distribution of the first two branches of the trigeminal nerve. Among Asians, the prevalence of the condition among Asians is estimated to be between 0.03% and 1.113%, while the prevalence among Blacks population is estimated to be between 0.01% and 0.016%, Shelby L. Kubicki, MD, said during a clinical abstract session at the annual meeting of the American Society for Laser Medicine and Surgery.
“Most existing literature describes the characteristics and treatment of Nevus of Ota based on Asian patients with skin types I-IV,” said Dr. Kubicki, a third-year dermatology resident at the University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston. “Special considerations are required when treating [Fitzpatrick skin types] V-VI, which is why it’s important to characterize these patients, to make sure they’re well represented in the literature.”
In what she said is the largest reported case series of its kind, Dr. Kubicki and colleagues identified eight Fitzpatrick skin type V or VI patients who underwent laser treatment for Nevus of Ota from 2016-2021. All were treated with the 1,064-nm Q‐switched Nd:YAG and on average, received 5.4 treatments at 2-10 month intervals. Fluence ranged from 1.8 to 2.4 J/cm2, and total pulse count ranged from 536.8 to 831.1. Two of these patients were additionally treated with 1,550-nm nonablative fractional resurfacing with a mean of six treatments. Primary outcomes were based on improvement of before and after clinical photographs by three independent board-certified dermatologists, who used a 5-point visual analogue scale for grading.
The mean age of patients was 30.4 years and ranged from 9 months to 45 years. Six were females and two were males, two had Fitzpatrick skin type V, and six had Fitzpatrick skin type VI. Of the eight patients, six had blue-gray lesions, one patient had a dark brown lesion, and one patient had “a hybrid lesion that had blue-gray and brown discoloration,” Dr. Kubicki said.
After grading of the clinical photographs, patients demonstrated a mean improvement of 51%-75% at follow-up 5-56 weeks after treatment (a mean of 16.9 weeks). No long-term adverse events were encountered in either group, but three patients developed mild guttate hypopigmentation following laser treatment.
“Lesional color may contribute to outcome, and patients should be educated about the risk of guttate hypopigmentation,” Dr. Kubicki said. “More studies are needed to determine the optimal device and treatment settings in this population.”
In an interview at the meeting, one of the session moderators, Oge Onwudiwe, MD, a dermatologist who practices at AllPhases Dermatology in Alexandria, Va., said that, while the study results impressed her, she speculated that the patients may require more treatments in the future. “What to look out for is the risk of rebound,” Dr. Onwudiwe said. “Because Nevus of Ota is a hamartomatous lesion, it’s very hard to treat, and sometimes it will come back. It will be nice to see how long this treatment can last. If you can use a combination therapy and have ... cases where you’re only needing a touch-up every so often, that’s still a win.”
Another session moderator, Eliot Battle, MD, CEO of Cultura Dermatology and Laser Center in Washington, D.C., said that he wondered what histologic analysis following treatment might show, and if a biopsy after treatment would show “if we really got rid of the nevus, or if we are just cosmetically improving the appearance temporarily.”
Neither Dr. Kubicki nor Dr. Onwudiwe reported having financial disclosures. Dr. Battle disclosed that he conducts research for Cynosure. He has also received discounts from Cynosure, Cutera, Solta Medical, Lumenis, Be Inc., and Sciton.
SAN DIEGO – Using a , results from a small single-center study showed.
Nevus of Ota is a benign melanocytic lesion that presents as a unilateral blue-gray to blue-brown facial patch favoring the distribution of the first two branches of the trigeminal nerve. Among Asians, the prevalence of the condition among Asians is estimated to be between 0.03% and 1.113%, while the prevalence among Blacks population is estimated to be between 0.01% and 0.016%, Shelby L. Kubicki, MD, said during a clinical abstract session at the annual meeting of the American Society for Laser Medicine and Surgery.
“Most existing literature describes the characteristics and treatment of Nevus of Ota based on Asian patients with skin types I-IV,” said Dr. Kubicki, a third-year dermatology resident at the University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston. “Special considerations are required when treating [Fitzpatrick skin types] V-VI, which is why it’s important to characterize these patients, to make sure they’re well represented in the literature.”
In what she said is the largest reported case series of its kind, Dr. Kubicki and colleagues identified eight Fitzpatrick skin type V or VI patients who underwent laser treatment for Nevus of Ota from 2016-2021. All were treated with the 1,064-nm Q‐switched Nd:YAG and on average, received 5.4 treatments at 2-10 month intervals. Fluence ranged from 1.8 to 2.4 J/cm2, and total pulse count ranged from 536.8 to 831.1. Two of these patients were additionally treated with 1,550-nm nonablative fractional resurfacing with a mean of six treatments. Primary outcomes were based on improvement of before and after clinical photographs by three independent board-certified dermatologists, who used a 5-point visual analogue scale for grading.
The mean age of patients was 30.4 years and ranged from 9 months to 45 years. Six were females and two were males, two had Fitzpatrick skin type V, and six had Fitzpatrick skin type VI. Of the eight patients, six had blue-gray lesions, one patient had a dark brown lesion, and one patient had “a hybrid lesion that had blue-gray and brown discoloration,” Dr. Kubicki said.
After grading of the clinical photographs, patients demonstrated a mean improvement of 51%-75% at follow-up 5-56 weeks after treatment (a mean of 16.9 weeks). No long-term adverse events were encountered in either group, but three patients developed mild guttate hypopigmentation following laser treatment.
“Lesional color may contribute to outcome, and patients should be educated about the risk of guttate hypopigmentation,” Dr. Kubicki said. “More studies are needed to determine the optimal device and treatment settings in this population.”
In an interview at the meeting, one of the session moderators, Oge Onwudiwe, MD, a dermatologist who practices at AllPhases Dermatology in Alexandria, Va., said that, while the study results impressed her, she speculated that the patients may require more treatments in the future. “What to look out for is the risk of rebound,” Dr. Onwudiwe said. “Because Nevus of Ota is a hamartomatous lesion, it’s very hard to treat, and sometimes it will come back. It will be nice to see how long this treatment can last. If you can use a combination therapy and have ... cases where you’re only needing a touch-up every so often, that’s still a win.”
Another session moderator, Eliot Battle, MD, CEO of Cultura Dermatology and Laser Center in Washington, D.C., said that he wondered what histologic analysis following treatment might show, and if a biopsy after treatment would show “if we really got rid of the nevus, or if we are just cosmetically improving the appearance temporarily.”
Neither Dr. Kubicki nor Dr. Onwudiwe reported having financial disclosures. Dr. Battle disclosed that he conducts research for Cynosure. He has also received discounts from Cynosure, Cutera, Solta Medical, Lumenis, Be Inc., and Sciton.
SAN DIEGO – Using a , results from a small single-center study showed.
Nevus of Ota is a benign melanocytic lesion that presents as a unilateral blue-gray to blue-brown facial patch favoring the distribution of the first two branches of the trigeminal nerve. Among Asians, the prevalence of the condition among Asians is estimated to be between 0.03% and 1.113%, while the prevalence among Blacks population is estimated to be between 0.01% and 0.016%, Shelby L. Kubicki, MD, said during a clinical abstract session at the annual meeting of the American Society for Laser Medicine and Surgery.
“Most existing literature describes the characteristics and treatment of Nevus of Ota based on Asian patients with skin types I-IV,” said Dr. Kubicki, a third-year dermatology resident at the University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston. “Special considerations are required when treating [Fitzpatrick skin types] V-VI, which is why it’s important to characterize these patients, to make sure they’re well represented in the literature.”
In what she said is the largest reported case series of its kind, Dr. Kubicki and colleagues identified eight Fitzpatrick skin type V or VI patients who underwent laser treatment for Nevus of Ota from 2016-2021. All were treated with the 1,064-nm Q‐switched Nd:YAG and on average, received 5.4 treatments at 2-10 month intervals. Fluence ranged from 1.8 to 2.4 J/cm2, and total pulse count ranged from 536.8 to 831.1. Two of these patients were additionally treated with 1,550-nm nonablative fractional resurfacing with a mean of six treatments. Primary outcomes were based on improvement of before and after clinical photographs by three independent board-certified dermatologists, who used a 5-point visual analogue scale for grading.
The mean age of patients was 30.4 years and ranged from 9 months to 45 years. Six were females and two were males, two had Fitzpatrick skin type V, and six had Fitzpatrick skin type VI. Of the eight patients, six had blue-gray lesions, one patient had a dark brown lesion, and one patient had “a hybrid lesion that had blue-gray and brown discoloration,” Dr. Kubicki said.
After grading of the clinical photographs, patients demonstrated a mean improvement of 51%-75% at follow-up 5-56 weeks after treatment (a mean of 16.9 weeks). No long-term adverse events were encountered in either group, but three patients developed mild guttate hypopigmentation following laser treatment.
“Lesional color may contribute to outcome, and patients should be educated about the risk of guttate hypopigmentation,” Dr. Kubicki said. “More studies are needed to determine the optimal device and treatment settings in this population.”
In an interview at the meeting, one of the session moderators, Oge Onwudiwe, MD, a dermatologist who practices at AllPhases Dermatology in Alexandria, Va., said that, while the study results impressed her, she speculated that the patients may require more treatments in the future. “What to look out for is the risk of rebound,” Dr. Onwudiwe said. “Because Nevus of Ota is a hamartomatous lesion, it’s very hard to treat, and sometimes it will come back. It will be nice to see how long this treatment can last. If you can use a combination therapy and have ... cases where you’re only needing a touch-up every so often, that’s still a win.”
Another session moderator, Eliot Battle, MD, CEO of Cultura Dermatology and Laser Center in Washington, D.C., said that he wondered what histologic analysis following treatment might show, and if a biopsy after treatment would show “if we really got rid of the nevus, or if we are just cosmetically improving the appearance temporarily.”
Neither Dr. Kubicki nor Dr. Onwudiwe reported having financial disclosures. Dr. Battle disclosed that he conducts research for Cynosure. He has also received discounts from Cynosure, Cutera, Solta Medical, Lumenis, Be Inc., and Sciton.
AT ASLMS 2022
Safety of combining fillers and lasers in one session evaluated over 6 years
SAN DIEGO – of the filled area, results from a single-center, retrospective study showed.
“Data on the safety of pairing single-session treatment with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser and fillers are lacking,” Shirin Bajaj, MD, said during a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “Anecdotally, we have found this to be completely safe in our high-volume laser center. We typically do fillers first, followed by laser treatment.”
For the study, Dr. Bajaj, a dermatology fellow at the Laser & Skin Surgery Center of New York, and colleagues retrospectively reviewed the charts of 638 patients who had 1,186 single‐session facial treatments with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser (Fraxel DUAL by Solta) and injectable hyaluronic acid filler from August 2015 to June 2021. Safety over the 6-year period was assessed by the adverse events that occurred within the first 4 weeks. The mean age of patients at the time of treatment was 60 years and 95% were female. Fitzpatrick skin types were type 1 (46.1%), type II (48.1%), type III (5.5%), and type IV (0.3%).
Most patients had 1 single‐session treatment (64.3%); the rest had 2 sessions (17.7%), 3 sessions (8%), or 4-18 sessions (10%). Most (91.2%) were treated with the 1,927-nm thulium laser, while 1.8% were treated with the 1,550-nm erbium laser; the mean total energy delivered was 1.3 kilojoules. A small number of patients (7.0%) received treatment with both lasers.
The most common area treated with filler injections were the cheeks and/or tear troughs (85.6%), followed by the perioral area and/or marionette lines (83.7%), temples (31%), nasolabial folds (25.5%), lips (24%), jawline (23.8%), chin (6.5%), forehead (1.4%), glabella and brows (0.5% each), neck (0.3%), and nose (0.1%). One syringe of filler was used in 58.7% of cases, compared with two syringes in 28.7% of cases, three syringes in 9.9% of cases, and four to six syringes in 2.8% of cases.
Dr. Bajaj reported that of the 1,186 single‐session treatments, no adverse events were recorded that were directly related to spread of filler or laser treatment of the filled area, including product migration, unexpected loss of filler volume, vascular occlusion, acute pain, cutaneous necrosis, blindness, and cutaneous burn. There were no hospital or emergency department transfers or admissions and referrals to ENT specialists or ophthalmologists for additional work‐up.
“This is at a busy cosmetic dermatology and plastic surgery practice,” Dr. Bajaj said. “Additional studies may be needed to further validate our findings.”
The study’s lead author was Jordan V. Wang, MD, who is medical research director at the Laser & Skin Surgery Center of New York.
“At most, this retrospective data confirms what we have known for years to be true: that combination treatments with injectables including fillers are safe,” Catherine M. DiGiorgio, MD, a dermatologist who practices at the Boston Center for Facial Rejuvenation, told this news organization. “This is a small study out of a single office, so that is a limitation. However, many dermatologists have performed Fraxel plus filler treatments in the same session daily for the last 10 years without any issues.”
Dr. DiGiorgio was asked to comment on the results and was not an investigator.
Dr. Bajaj reported having no financial disclosures. Dr. Wang reported that he has received grants and/or research funding from ALASTIN Skincare, Cynosure, Lutronic, Novoxel, Sofwave, Solta Medical, Blossom Innovations, Allergan, Accure Acne Inc., and Soliton. Dr. DiGiorgio reported having no relevant disclosures.
SAN DIEGO – of the filled area, results from a single-center, retrospective study showed.
“Data on the safety of pairing single-session treatment with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser and fillers are lacking,” Shirin Bajaj, MD, said during a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “Anecdotally, we have found this to be completely safe in our high-volume laser center. We typically do fillers first, followed by laser treatment.”
For the study, Dr. Bajaj, a dermatology fellow at the Laser & Skin Surgery Center of New York, and colleagues retrospectively reviewed the charts of 638 patients who had 1,186 single‐session facial treatments with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser (Fraxel DUAL by Solta) and injectable hyaluronic acid filler from August 2015 to June 2021. Safety over the 6-year period was assessed by the adverse events that occurred within the first 4 weeks. The mean age of patients at the time of treatment was 60 years and 95% were female. Fitzpatrick skin types were type 1 (46.1%), type II (48.1%), type III (5.5%), and type IV (0.3%).
Most patients had 1 single‐session treatment (64.3%); the rest had 2 sessions (17.7%), 3 sessions (8%), or 4-18 sessions (10%). Most (91.2%) were treated with the 1,927-nm thulium laser, while 1.8% were treated with the 1,550-nm erbium laser; the mean total energy delivered was 1.3 kilojoules. A small number of patients (7.0%) received treatment with both lasers.
The most common area treated with filler injections were the cheeks and/or tear troughs (85.6%), followed by the perioral area and/or marionette lines (83.7%), temples (31%), nasolabial folds (25.5%), lips (24%), jawline (23.8%), chin (6.5%), forehead (1.4%), glabella and brows (0.5% each), neck (0.3%), and nose (0.1%). One syringe of filler was used in 58.7% of cases, compared with two syringes in 28.7% of cases, three syringes in 9.9% of cases, and four to six syringes in 2.8% of cases.
Dr. Bajaj reported that of the 1,186 single‐session treatments, no adverse events were recorded that were directly related to spread of filler or laser treatment of the filled area, including product migration, unexpected loss of filler volume, vascular occlusion, acute pain, cutaneous necrosis, blindness, and cutaneous burn. There were no hospital or emergency department transfers or admissions and referrals to ENT specialists or ophthalmologists for additional work‐up.
“This is at a busy cosmetic dermatology and plastic surgery practice,” Dr. Bajaj said. “Additional studies may be needed to further validate our findings.”
The study’s lead author was Jordan V. Wang, MD, who is medical research director at the Laser & Skin Surgery Center of New York.
“At most, this retrospective data confirms what we have known for years to be true: that combination treatments with injectables including fillers are safe,” Catherine M. DiGiorgio, MD, a dermatologist who practices at the Boston Center for Facial Rejuvenation, told this news organization. “This is a small study out of a single office, so that is a limitation. However, many dermatologists have performed Fraxel plus filler treatments in the same session daily for the last 10 years without any issues.”
Dr. DiGiorgio was asked to comment on the results and was not an investigator.
Dr. Bajaj reported having no financial disclosures. Dr. Wang reported that he has received grants and/or research funding from ALASTIN Skincare, Cynosure, Lutronic, Novoxel, Sofwave, Solta Medical, Blossom Innovations, Allergan, Accure Acne Inc., and Soliton. Dr. DiGiorgio reported having no relevant disclosures.
SAN DIEGO – of the filled area, results from a single-center, retrospective study showed.
“Data on the safety of pairing single-session treatment with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser and fillers are lacking,” Shirin Bajaj, MD, said during a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “Anecdotally, we have found this to be completely safe in our high-volume laser center. We typically do fillers first, followed by laser treatment.”
For the study, Dr. Bajaj, a dermatology fellow at the Laser & Skin Surgery Center of New York, and colleagues retrospectively reviewed the charts of 638 patients who had 1,186 single‐session facial treatments with nonablative fractional 1,927-nm thulium and/or 1,550-nm erbium laser (Fraxel DUAL by Solta) and injectable hyaluronic acid filler from August 2015 to June 2021. Safety over the 6-year period was assessed by the adverse events that occurred within the first 4 weeks. The mean age of patients at the time of treatment was 60 years and 95% were female. Fitzpatrick skin types were type 1 (46.1%), type II (48.1%), type III (5.5%), and type IV (0.3%).
Most patients had 1 single‐session treatment (64.3%); the rest had 2 sessions (17.7%), 3 sessions (8%), or 4-18 sessions (10%). Most (91.2%) were treated with the 1,927-nm thulium laser, while 1.8% were treated with the 1,550-nm erbium laser; the mean total energy delivered was 1.3 kilojoules. A small number of patients (7.0%) received treatment with both lasers.
The most common area treated with filler injections were the cheeks and/or tear troughs (85.6%), followed by the perioral area and/or marionette lines (83.7%), temples (31%), nasolabial folds (25.5%), lips (24%), jawline (23.8%), chin (6.5%), forehead (1.4%), glabella and brows (0.5% each), neck (0.3%), and nose (0.1%). One syringe of filler was used in 58.7% of cases, compared with two syringes in 28.7% of cases, three syringes in 9.9% of cases, and four to six syringes in 2.8% of cases.
Dr. Bajaj reported that of the 1,186 single‐session treatments, no adverse events were recorded that were directly related to spread of filler or laser treatment of the filled area, including product migration, unexpected loss of filler volume, vascular occlusion, acute pain, cutaneous necrosis, blindness, and cutaneous burn. There were no hospital or emergency department transfers or admissions and referrals to ENT specialists or ophthalmologists for additional work‐up.
“This is at a busy cosmetic dermatology and plastic surgery practice,” Dr. Bajaj said. “Additional studies may be needed to further validate our findings.”
The study’s lead author was Jordan V. Wang, MD, who is medical research director at the Laser & Skin Surgery Center of New York.
“At most, this retrospective data confirms what we have known for years to be true: that combination treatments with injectables including fillers are safe,” Catherine M. DiGiorgio, MD, a dermatologist who practices at the Boston Center for Facial Rejuvenation, told this news organization. “This is a small study out of a single office, so that is a limitation. However, many dermatologists have performed Fraxel plus filler treatments in the same session daily for the last 10 years without any issues.”
Dr. DiGiorgio was asked to comment on the results and was not an investigator.
Dr. Bajaj reported having no financial disclosures. Dr. Wang reported that he has received grants and/or research funding from ALASTIN Skincare, Cynosure, Lutronic, Novoxel, Sofwave, Solta Medical, Blossom Innovations, Allergan, Accure Acne Inc., and Soliton. Dr. DiGiorgio reported having no relevant disclosures.
AT ASLMS 2022
Device that couples US, radiofrequency shows promise for wrinkles, skin laxity
SAN DIEGO – .
“We’ve done a lot of work with radiofrequency, and we’ve done a lot of work with ultrasound,” Suneel Chilukuri, MD, said in an interview in advance of a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “The question becomes, is there truly a difference if we’re combining them together?”
To find out, Dr. Chilukuri, a dermatologist who practices in Houston, Tex., and colleagues conducted an IRB-approved trial of a new device that allows for the delivery of radiofrequency (RF) and targeted ultrasound (TUS) in a single applicator. The device, which is not yet named, has been cleared by the Food and Drug Administration and is expected to be available in the fourth quarter of 2022.
In a single‐blinded study, 21 adults were randomized to receive RF and TUS (group A), while 20 received RF alone (group B). The mean age of patients was 57 years and 38 were women. Patients in each group received four full‐face treatments delivered once per week. Dr. Chilukuri and colleagues used the ElastiMeter to quantitatively measure skin properties at baseline, 1‐month, and 3‐month follow‐up visits. They also took digital photos at each follow-up visit and applied the Fitzpatrick Wrinkle and Elastosis Scale (FWS), and the Global Aesthetic Improvement Scale (GAIS scale) to each one, in addition to performing 3D analysis.
Dr. Chilukuri reported that patients in group A showed superior improvement of skin elasticity compared with those in group B. At 3 months, the preliminary skin elasticity data showed an improvement in the periorbital region by 13.6 N/m (34.7% improvement) and 8.1 N/m (22.2% improvement) in group A and B, respectively. (N/m is a measure of elasticity.)
3D photographs also demonstrated superior results in group A, achieving an improvement of 5.3 points (27.7%) and 4.6 points (24.4%) in wrinkles and skin evenness, respectively. Those in group A achieved marked improvement in both FWS and GAIS scales, compared with their counterparts in group B, he said.
“I think this is going to be one more very useful, versatile tool in our toolbox,” Dr. Chilukuri said of the new device, noting that for both the investigators and the patients, there was greater treatment satisfaction for the areas treated with combined radiofrequency and ultrasound. “It’s something that’s effective, painless, and the treatment time is very short – approximately 10 minutes per side. It’s extremely tolerable and the results were similar to 6-month results I get with fractionated ablative resurfacing, but without the downtime, without the handholding, without any pain.”
Moreover, he added, many patients in the trial have asked to have further treatments “and are on a waiting list for when the product launches.”
He and his colleagues also observed improvements in skin hydration among patients in group A, based on readings from a MoistureMeterSC, which measures skin hydration, a finding that he characterized as “unexpected and interesting.”
Dr. Chilukuri speculated that combining TUS and RF allows for better heat dispersion into the epidermis. “If you get to the proper temperature, which is somewhere between 40 and 42 degrees, and if you can keep it for about 10 minutes, we know that there will be proper stimulation of senescent fibroblasts,” he explained.
“I can’t say that seborrheic keratosis is improved or hyperpigmentation is improved, but the heat generation leads to immediate vasodilation to improve blood flow to treated areas. That results in immediate collagen contraction as well as improved autophagy, removal of age-related cellular debris. With the long term neovascularization, you’re going to see more change with the fibroblast activity leading to collagenesis and elastogenesis.”
Use of the device is not indicated for patients with metal implants in the head and neck region, he noted. “I’d also be cautious about using it in people with melasma as the device’s mechanism is based on heat,” since current scientific evidence shows that heat can worsen melasma, he added. “For now, I recommend caution until we perform a split-face study or develop specific treatment parameters for those patients with melasma.”
“We know that skin tightening is a difficult task for a nonablative, nonsurgical device,” said Murad Alam, MD, professor and vice-chair of dermatology and chief of the section of cutaneous and aesthetic surgery at Northwestern University, Chicago, who was asked to comment on the study.
“The promise is of limited downtime, lack of scars, and minimal discomfort, but we haven’t yet had a home run. As a consequence, there’s a constant effort to develop new and better devices. This study is interesting because it shows that yes, a new and better device might be good, but let’s not overlook the idea of having multiple devices at the same time. The nice thing they’ve shown is that from a safety standpoint, using both radiofrequency and ultrasound was tolerable in terms of safety, discomfort, and downtime.”
BTL Aesthetics, the manufacturer, loaned the device used in the trial. Dr. Chilukuri reported having no other financial conflicts for this study. Dr. Alam reported having no disclosures.
SAN DIEGO – .
“We’ve done a lot of work with radiofrequency, and we’ve done a lot of work with ultrasound,” Suneel Chilukuri, MD, said in an interview in advance of a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “The question becomes, is there truly a difference if we’re combining them together?”
To find out, Dr. Chilukuri, a dermatologist who practices in Houston, Tex., and colleagues conducted an IRB-approved trial of a new device that allows for the delivery of radiofrequency (RF) and targeted ultrasound (TUS) in a single applicator. The device, which is not yet named, has been cleared by the Food and Drug Administration and is expected to be available in the fourth quarter of 2022.
In a single‐blinded study, 21 adults were randomized to receive RF and TUS (group A), while 20 received RF alone (group B). The mean age of patients was 57 years and 38 were women. Patients in each group received four full‐face treatments delivered once per week. Dr. Chilukuri and colleagues used the ElastiMeter to quantitatively measure skin properties at baseline, 1‐month, and 3‐month follow‐up visits. They also took digital photos at each follow-up visit and applied the Fitzpatrick Wrinkle and Elastosis Scale (FWS), and the Global Aesthetic Improvement Scale (GAIS scale) to each one, in addition to performing 3D analysis.
Dr. Chilukuri reported that patients in group A showed superior improvement of skin elasticity compared with those in group B. At 3 months, the preliminary skin elasticity data showed an improvement in the periorbital region by 13.6 N/m (34.7% improvement) and 8.1 N/m (22.2% improvement) in group A and B, respectively. (N/m is a measure of elasticity.)
3D photographs also demonstrated superior results in group A, achieving an improvement of 5.3 points (27.7%) and 4.6 points (24.4%) in wrinkles and skin evenness, respectively. Those in group A achieved marked improvement in both FWS and GAIS scales, compared with their counterparts in group B, he said.
“I think this is going to be one more very useful, versatile tool in our toolbox,” Dr. Chilukuri said of the new device, noting that for both the investigators and the patients, there was greater treatment satisfaction for the areas treated with combined radiofrequency and ultrasound. “It’s something that’s effective, painless, and the treatment time is very short – approximately 10 minutes per side. It’s extremely tolerable and the results were similar to 6-month results I get with fractionated ablative resurfacing, but without the downtime, without the handholding, without any pain.”
Moreover, he added, many patients in the trial have asked to have further treatments “and are on a waiting list for when the product launches.”
He and his colleagues also observed improvements in skin hydration among patients in group A, based on readings from a MoistureMeterSC, which measures skin hydration, a finding that he characterized as “unexpected and interesting.”
Dr. Chilukuri speculated that combining TUS and RF allows for better heat dispersion into the epidermis. “If you get to the proper temperature, which is somewhere between 40 and 42 degrees, and if you can keep it for about 10 minutes, we know that there will be proper stimulation of senescent fibroblasts,” he explained.
“I can’t say that seborrheic keratosis is improved or hyperpigmentation is improved, but the heat generation leads to immediate vasodilation to improve blood flow to treated areas. That results in immediate collagen contraction as well as improved autophagy, removal of age-related cellular debris. With the long term neovascularization, you’re going to see more change with the fibroblast activity leading to collagenesis and elastogenesis.”
Use of the device is not indicated for patients with metal implants in the head and neck region, he noted. “I’d also be cautious about using it in people with melasma as the device’s mechanism is based on heat,” since current scientific evidence shows that heat can worsen melasma, he added. “For now, I recommend caution until we perform a split-face study or develop specific treatment parameters for those patients with melasma.”
“We know that skin tightening is a difficult task for a nonablative, nonsurgical device,” said Murad Alam, MD, professor and vice-chair of dermatology and chief of the section of cutaneous and aesthetic surgery at Northwestern University, Chicago, who was asked to comment on the study.
“The promise is of limited downtime, lack of scars, and minimal discomfort, but we haven’t yet had a home run. As a consequence, there’s a constant effort to develop new and better devices. This study is interesting because it shows that yes, a new and better device might be good, but let’s not overlook the idea of having multiple devices at the same time. The nice thing they’ve shown is that from a safety standpoint, using both radiofrequency and ultrasound was tolerable in terms of safety, discomfort, and downtime.”
BTL Aesthetics, the manufacturer, loaned the device used in the trial. Dr. Chilukuri reported having no other financial conflicts for this study. Dr. Alam reported having no disclosures.
SAN DIEGO – .
“We’ve done a lot of work with radiofrequency, and we’ve done a lot of work with ultrasound,” Suneel Chilukuri, MD, said in an interview in advance of a clinical abstract session at the annual conference of the American Society for Laser Medicine and Surgery. “The question becomes, is there truly a difference if we’re combining them together?”
To find out, Dr. Chilukuri, a dermatologist who practices in Houston, Tex., and colleagues conducted an IRB-approved trial of a new device that allows for the delivery of radiofrequency (RF) and targeted ultrasound (TUS) in a single applicator. The device, which is not yet named, has been cleared by the Food and Drug Administration and is expected to be available in the fourth quarter of 2022.
In a single‐blinded study, 21 adults were randomized to receive RF and TUS (group A), while 20 received RF alone (group B). The mean age of patients was 57 years and 38 were women. Patients in each group received four full‐face treatments delivered once per week. Dr. Chilukuri and colleagues used the ElastiMeter to quantitatively measure skin properties at baseline, 1‐month, and 3‐month follow‐up visits. They also took digital photos at each follow-up visit and applied the Fitzpatrick Wrinkle and Elastosis Scale (FWS), and the Global Aesthetic Improvement Scale (GAIS scale) to each one, in addition to performing 3D analysis.
Dr. Chilukuri reported that patients in group A showed superior improvement of skin elasticity compared with those in group B. At 3 months, the preliminary skin elasticity data showed an improvement in the periorbital region by 13.6 N/m (34.7% improvement) and 8.1 N/m (22.2% improvement) in group A and B, respectively. (N/m is a measure of elasticity.)
3D photographs also demonstrated superior results in group A, achieving an improvement of 5.3 points (27.7%) and 4.6 points (24.4%) in wrinkles and skin evenness, respectively. Those in group A achieved marked improvement in both FWS and GAIS scales, compared with their counterparts in group B, he said.
“I think this is going to be one more very useful, versatile tool in our toolbox,” Dr. Chilukuri said of the new device, noting that for both the investigators and the patients, there was greater treatment satisfaction for the areas treated with combined radiofrequency and ultrasound. “It’s something that’s effective, painless, and the treatment time is very short – approximately 10 minutes per side. It’s extremely tolerable and the results were similar to 6-month results I get with fractionated ablative resurfacing, but without the downtime, without the handholding, without any pain.”
Moreover, he added, many patients in the trial have asked to have further treatments “and are on a waiting list for when the product launches.”
He and his colleagues also observed improvements in skin hydration among patients in group A, based on readings from a MoistureMeterSC, which measures skin hydration, a finding that he characterized as “unexpected and interesting.”
Dr. Chilukuri speculated that combining TUS and RF allows for better heat dispersion into the epidermis. “If you get to the proper temperature, which is somewhere between 40 and 42 degrees, and if you can keep it for about 10 minutes, we know that there will be proper stimulation of senescent fibroblasts,” he explained.
“I can’t say that seborrheic keratosis is improved or hyperpigmentation is improved, but the heat generation leads to immediate vasodilation to improve blood flow to treated areas. That results in immediate collagen contraction as well as improved autophagy, removal of age-related cellular debris. With the long term neovascularization, you’re going to see more change with the fibroblast activity leading to collagenesis and elastogenesis.”
Use of the device is not indicated for patients with metal implants in the head and neck region, he noted. “I’d also be cautious about using it in people with melasma as the device’s mechanism is based on heat,” since current scientific evidence shows that heat can worsen melasma, he added. “For now, I recommend caution until we perform a split-face study or develop specific treatment parameters for those patients with melasma.”
“We know that skin tightening is a difficult task for a nonablative, nonsurgical device,” said Murad Alam, MD, professor and vice-chair of dermatology and chief of the section of cutaneous and aesthetic surgery at Northwestern University, Chicago, who was asked to comment on the study.
“The promise is of limited downtime, lack of scars, and minimal discomfort, but we haven’t yet had a home run. As a consequence, there’s a constant effort to develop new and better devices. This study is interesting because it shows that yes, a new and better device might be good, but let’s not overlook the idea of having multiple devices at the same time. The nice thing they’ve shown is that from a safety standpoint, using both radiofrequency and ultrasound was tolerable in terms of safety, discomfort, and downtime.”
BTL Aesthetics, the manufacturer, loaned the device used in the trial. Dr. Chilukuri reported having no other financial conflicts for this study. Dr. Alam reported having no disclosures.
AT ASLMS 2022
Acid series: Trichloroacetic acid
– yet can be one of the most dangerous treatments in the hands of an untrained user.
TCA, in a clear colorless solution, is available in concentrations up to 100%, and has not been associated with allergic reactions or systemic toxicity. The available concentrations include those used for superficial depth peels (10%-30%), medium depth peels (35%-50%), and deep peels (greater than 50%).
TCA causes coagulation of the cellular membrane of epidermal proteins in the epidermis and, depending on the concentration, the dermis, which results in frosting of the skin. Repair of the epidermal cells induces resurfacing of the skin and neocollagenesis. TCA can be combined with other acids, including glycolic acid (Coleman peel), Jessner solution (Monheit peel), and solid CO2 (Brody peel). It has also been combined with lactic acid, mandelic acid, and salicylic acid in combination peels of various concentrations.
Although there are many studies, case reports, and textbooks related to this topic and the applications, combinations and treatment options for TCA peels, it is important to highlight here how many of these solutions – at high concentrations – are available directly to consumers, med spas, and the general public through online websites, including Amazon and overseas sites. Over the last 15 years, I have seen complications of this acid alone in people who have bought TCA online, related to applications not just on the face but on the body, neck, eyes, vaginal, and anal areas. Pigmentation, erosions, ulcers, and strictures are just some of the possible complications that occur not just with a more concentrated solution, but more often from application errors, aggressive layering of the acid, allowing the acid to sit on the skin too long, and improper tissue prepping and posttreatment skin care.
TCA can be an untamable acid, with little control over the depth of penetration even in the most controlled situations. The inability to be neutralize TCA creates an environment in which the depth of penetration and tissue coagulation is not a precise science. Once applied, the tissue reaction cannot be “stopped” or rapidly reversed making it highly variable in its mechanism. Patients of all skin types have the potential to develop complications as the epidermal and dermal thickness, moisture content, sebum production, and pigmentation are highly varied between individuals.
In my opinion, it is a dangerous product to have on the market – not just for the untrained medical providers using it but for estheticians and the general public who now can buy TCA anywhere.
But with effective training, reliable sourcing and appropriate preparation of the patient’s skin, however, a TCA peel can be a highly effective tool for difficult-to-treat dermatological problems, such as scarring and xanthelasma.
Dr. Talakoub and Naissan O. Wesley, MD, 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. She has no relevant disclosures. Write to them at [email protected].
– yet can be one of the most dangerous treatments in the hands of an untrained user.
TCA, in a clear colorless solution, is available in concentrations up to 100%, and has not been associated with allergic reactions or systemic toxicity. The available concentrations include those used for superficial depth peels (10%-30%), medium depth peels (35%-50%), and deep peels (greater than 50%).
TCA causes coagulation of the cellular membrane of epidermal proteins in the epidermis and, depending on the concentration, the dermis, which results in frosting of the skin. Repair of the epidermal cells induces resurfacing of the skin and neocollagenesis. TCA can be combined with other acids, including glycolic acid (Coleman peel), Jessner solution (Monheit peel), and solid CO2 (Brody peel). It has also been combined with lactic acid, mandelic acid, and salicylic acid in combination peels of various concentrations.
Although there are many studies, case reports, and textbooks related to this topic and the applications, combinations and treatment options for TCA peels, it is important to highlight here how many of these solutions – at high concentrations – are available directly to consumers, med spas, and the general public through online websites, including Amazon and overseas sites. Over the last 15 years, I have seen complications of this acid alone in people who have bought TCA online, related to applications not just on the face but on the body, neck, eyes, vaginal, and anal areas. Pigmentation, erosions, ulcers, and strictures are just some of the possible complications that occur not just with a more concentrated solution, but more often from application errors, aggressive layering of the acid, allowing the acid to sit on the skin too long, and improper tissue prepping and posttreatment skin care.
TCA can be an untamable acid, with little control over the depth of penetration even in the most controlled situations. The inability to be neutralize TCA creates an environment in which the depth of penetration and tissue coagulation is not a precise science. Once applied, the tissue reaction cannot be “stopped” or rapidly reversed making it highly variable in its mechanism. Patients of all skin types have the potential to develop complications as the epidermal and dermal thickness, moisture content, sebum production, and pigmentation are highly varied between individuals.
In my opinion, it is a dangerous product to have on the market – not just for the untrained medical providers using it but for estheticians and the general public who now can buy TCA anywhere.
But with effective training, reliable sourcing and appropriate preparation of the patient’s skin, however, a TCA peel can be a highly effective tool for difficult-to-treat dermatological problems, such as scarring and xanthelasma.
Dr. Talakoub and Naissan O. Wesley, MD, 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. She has no relevant disclosures. Write to them at [email protected].
– yet can be one of the most dangerous treatments in the hands of an untrained user.
TCA, in a clear colorless solution, is available in concentrations up to 100%, and has not been associated with allergic reactions or systemic toxicity. The available concentrations include those used for superficial depth peels (10%-30%), medium depth peels (35%-50%), and deep peels (greater than 50%).
TCA causes coagulation of the cellular membrane of epidermal proteins in the epidermis and, depending on the concentration, the dermis, which results in frosting of the skin. Repair of the epidermal cells induces resurfacing of the skin and neocollagenesis. TCA can be combined with other acids, including glycolic acid (Coleman peel), Jessner solution (Monheit peel), and solid CO2 (Brody peel). It has also been combined with lactic acid, mandelic acid, and salicylic acid in combination peels of various concentrations.
Although there are many studies, case reports, and textbooks related to this topic and the applications, combinations and treatment options for TCA peels, it is important to highlight here how many of these solutions – at high concentrations – are available directly to consumers, med spas, and the general public through online websites, including Amazon and overseas sites. Over the last 15 years, I have seen complications of this acid alone in people who have bought TCA online, related to applications not just on the face but on the body, neck, eyes, vaginal, and anal areas. Pigmentation, erosions, ulcers, and strictures are just some of the possible complications that occur not just with a more concentrated solution, but more often from application errors, aggressive layering of the acid, allowing the acid to sit on the skin too long, and improper tissue prepping and posttreatment skin care.
TCA can be an untamable acid, with little control over the depth of penetration even in the most controlled situations. The inability to be neutralize TCA creates an environment in which the depth of penetration and tissue coagulation is not a precise science. Once applied, the tissue reaction cannot be “stopped” or rapidly reversed making it highly variable in its mechanism. Patients of all skin types have the potential to develop complications as the epidermal and dermal thickness, moisture content, sebum production, and pigmentation are highly varied between individuals.
In my opinion, it is a dangerous product to have on the market – not just for the untrained medical providers using it but for estheticians and the general public who now can buy TCA anywhere.
But with effective training, reliable sourcing and appropriate preparation of the patient’s skin, however, a TCA peel can be a highly effective tool for difficult-to-treat dermatological problems, such as scarring and xanthelasma.
Dr. Talakoub and Naissan O. Wesley, MD, 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. She has no relevant disclosures. Write to them at [email protected].
FDA warns companies selling OTC skin lighteners
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
Cupping in dermatology
My inspiration to write about cupping this month stems from the perception that everyone seems to be talking about it, from a facialist who suggested it for me to a coworker who swears by cupping to treat her allergies. Cupping is by no means a novel procedure. Its use as a health therapy dates back thousands of years to ancient Egypt (1500 BCE), ancient Greece (described by Hippocrates), ancient Rome (described by the Greek physician Galen), China (during the Han dynasty, 206 BCE to 220 CE) and traditional Islamic culture.1 Over the past decade, the popularity of this ancient procedure has been increasing in the United States.1 Cupping has been applied as a remedy for various dermatologic and medical conditions, including herpes zoster, headaches, diminished appetite, maldigestion, abscess evacuation, narcolepsy, pain, fever, dysmenorrhea, and gout.1,2
Theories on the mechanism(s) of action
The practice of cupping is differentiated into dry and wet cupping.1,2 Traditionally, with dry cupping, a flame is applied to heat the air inside a thick glass cup (rather than the cup itself).1 The cup is placed on the skin surface, and negative pressure suctions the skin into the cup. Wet cupping differs mainly from dry cupping in that it involves blood-letting. Cups made of either silicone or glass of varying size and shapes are used. Modern adaptations to cupping include needle, herbal, and pulsatile cupping, as well as a “moving cupping” technique (vs. traditionally stationary cups).1
There are several theories, many of which are derived from the nondermatologic literature (that is, pain management), as to how cupping may deliver a clinical benefit. Some theories are based in scientific and medical principles, whereas other theories are more whimsical – specifically, that cupping draws out evil spirits.2 Studies of dry cupping have suggested that the procedure results in increased oxygenation of muscles via a local increase in oxygenated hemoglobin, which may help improve muscular activity and reduce pain.1 As theorized by Lowe in 2017, negative pressure exerted by dry cupping leads to stretching and dilation of capillaries, which increases blood flow.3 Wet cupping has been shown to increase heat shock protein 70 (HSP70) and beta-endorphin expression in rat models, which is thought to facilitate pain management.1 Removal of oxidants and reduction of reactive oxygen species in the blood is believed to be among the benefits of wet cupping.1
Cupping in general dermatology
While , as well as various inflammatory conditions.
Herpes zoster
In 2010, Cao et al. reported on their systematic review of wet cupping after completing searches of multiple databases (that is, PubMed, the Cochrane Library [Issue 3, 2008], China Network Knowledge Infrastructure, Chinese Scientific Journal Database, and Wan Fang Database). They identified eight randomized controlled trials involving 651 patients, with meta-analyses revealing that wet cupping performed better than medications in terms of the number of “cured” patients, number of patients with improved symptoms, and a lower incidence of postherpetic neuralgia. Wet cupping, in addition to medication, was also found to be superior to medication alone in multiple patients. The researchers concluded that wet cupping appears to effectively treat herpes zoster.4 However, the study failed to identify which medications were used to treat herpes zoster. In the United States, common medications for herpes zoster include acyclovir, valacyclovir, steroids, gabapentin, and other neuromodulators. Without knowing which medications were used, it is difficult to compare cupping to medication in terms of efficacy in treating herpes zoster.
Urticaria
Urticaria (hives) is an inflammatory skin condition that can be very uncomfortable for patients but often resolves without intervention within several months after onset. In 2001, Li and Ding reported on the treatment with cupping of 40 patients with urticaria. The cure rate among the treatment group was cited as 55%, compared with 30% in the control group, who were treated with a traditional Chinese remedy and an unidentified first-generation antihistamine.1,5 In 2020, Xiao et al. conducted a systematic review and meta-analysis of cupping therapy for patients with chronic urticaria. They identified 13 comparisons from 12 randomized controlled trials involving 842 subjects. The investigators found no significant differences between wet cupping and medication usage. They also found that cupping combined with antihistamine treatment was superior to antihistamines alone, and cupping therapy with acupuncture was more effective than acupuncture alone. The investigators did call for caution, citing the poor quality of the studies reviewed.6
It is important to note that it is difficult to attribute resolution of urticaria to the use of cupping given the self-resolution often associated with this condition. Antihistamines are the mainstay of therapy for urticaria, but in my personal experience, patients are not entirely satisfied with the level of symptom control with antihistamines alone and often search for alternative therapies to control the pesky hives and associated itch. In 2014, omalizumab (Xolair) was approved for treating chronic idiopathic urticaria, which has helped patients control symptoms of chronic idiopathic urticaria without needing to take antihistamines. There was no indication that the studies reviewed by Xiao et al. compared cupping against this new effective treatment. Therefore, these studies comparing cupping to medical management are outdated.
Acne, eczema, and psoriasis
Soliman’s 2018 review of cupping in dermatology included a few studies on these common cutaneous conditions. For instance, a 2013 single-blind prospective study by Xu et al. reported on the results of patients with moderate acne who received wet cupping (in the form of prickling bloodletting) twice weekly for 6 weeks.7 They reported that patients demonstrated improvement in the global acne grading system (GAGS) score by the end of the trial.1,7 Unfortunately, cupping was not compared with standard acne treatments (that is, benzoyl peroxide, topical and oral antibiotics, isotretinoin, topical retinoids, spironolactone).
In evaluating cupping for acute eczema, wet cupping was compared with oral loratadine and topical ointments in a 2007 study by Yao and Li. They divided 88 cases into treatment and control groups, with the former group (n = 46) receiving bloodletting puncturing and cupping and the control group (n = 42) receiving oral loratadine and topical Pairuisong (an herbal ointment used in Chinese medicine). The investigators observed no significant difference in total effective rates but a superior difference in the rates of responses that were considered “cured” and “markedly effective” in favor of the cupping treatment.1,8 However, a case report by Hon et al. has indicated that cupping therapy may be associated with more harm than benefit when used as an eczema treatment.1,9
In addition, it is important to note that the past 5 years have been gamechanging in the management of chronic eczema in terms of the array of novel and effective therapies (e.g., dupilumab and JAK inhibitors) and chronic moderate-to-severe eczema has become very treatable. Similarly, acute eczema is often successfully managed with topical steroids, calcineurin inhibitors, and emollients. As such, there is no compelling reason to consider an unproven treatment such as cupping.
In 2020, Xing et al. reviewed 16 randomized controlled trials assessing the use of “moving cupping” for plaque psoriasis, with 1,164 patients meeting inclusion criteria. Moving cupping was found to be significantly more effective than “no-moving” cupping therapy, and moving cupping, combined with medications, performed better than medications alone.10 None of the trials evaluated in this study included randomized controlled trials that compared patients using any of the more modern psoriasis medications, specifically biologics. And, again, the studies evaluated were not of the highest quality.
The data that support cupping, as summarized above, are based mostly on case reports, and strong double-blind prospective studies are lacking. Additionally, most of the studies cited gauged the efficacy of cupping using qualitative endpoints, rather than standardized quantitative endpoints and scales. Moreover, spontaneous remission of various dermatoses can occur, or they can improve over time, including acute eczema, psoriasis, and, especially, urticaria.
Adverse effects of cupping
Often alternative therapies are seen as “benign” and without adverse effects. However, complications can result from cupping. Trauma can be induced from the cupping itself by damaging superficial blood vessels and causing bruising.1,11 Blistering can also occur secondary to the suction effect, and the epidermal and dermal layers of the skin can be separated.1,11 Further, burns and discoloration have also been noted secondary to heat, trauma, and post inflammatory pigmentary changes.1,11 Another risk of cupping is the Koebner phenomenon, which occurs with psoriasis, with new lesions appearing in traumatized skin.12 Other adverse outcomes that have been reported with cupping include reactivation of herpes simplex virus secondary to skin trauma, iron deficiency anemia (secondary to blood loss), panniculitis, infections, and residual marks mistaken for signs of child abuse.1,11
Cupping in aesthetic dermatology
Facial cupping, a distinct practice from body cupping used to treat general dermatology conditions described previously, is also increasing in popularity. This practice is usually conducted in association with a facial or facial acupuncture by an aesthetician or other licensed professional. It can also be performed using at-home kits. The marketing claims for facial cupping cite improved tightening and contouring of facial skin, increased facial microcirculation and collagen synthesis, and enhanced lymphatic flow to aid with facial puffiness or swelling. One supposed mechanism for these benefits is that cupping increases blood flow. Interestingly, there was a 2020 animal study in which photoacoustic imaging of a mouse ear revealed increased temporary blood flow in the cupping microenvironment.13 Currently, however, there is no evidence in the English scientific literature that supports facial cupping. The benefits attributed to facial cupping for aesthetic purposes have emerged only in personal anecdotes. The temporary increase in blood flow may induce inflammation and swelling that adds volume to the face and temporarily diminishes wrinkles. However, this temporary plumpness may be associated with adverse effects, such as local trauma, irritation, bruising, postinflammatory pigmentary alteration, or even herpes reactivation. In my opinion, the possible adverse effects of cupping outweigh any potential benefit, especially given the insufficient evidence supporting the utility of cupping for cosmetic enhancement.
Summary
There is increasing interest among patients to incorporate complementary and alternative medicine – including the ancient tradition of cupping – in managing medical dermatologic conditions. However, current evidence supporting cupping as an effective therapeutic strategy is not strong, with most studies to date appearing to be of poor quality or not sufficiently convincing to displace standard therapies. Our medical strategies for managing chronic dermatologic conditions, particularly inflammatory disorders, continue to improve from both a safety and a proven efficacy standpoint. Therefore, I would not forgo medical management in favor of cupping. While cupping can be used as an adjunct therapy, I would caution patients about possible adverse side effects. In the aesthetic world, cupping is also gaining popularity, but this trend is also not supported by current evidence or studies, at least in the Western literature.
Dr. Goldman is a dermatologist in private practice in Miami and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a general dermatology practice. Write to her at [email protected] or message her on Instragram @DrChloeGoldman. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other disclosures.
References
1. Soliman Y et al. Acta Dermatovenerol Alp Pannonica Adriat. 2018 Jun;27(2):103-7.
2. França K and Lotti T. Advances in Integrative Dermatology. John Wiley & Sons, 2019.
3. Lowe DT. Complement Ther Clin Pract. 2017 Nov;29:162-8.
4.Cao H et al. Altern Ther Health Med. 2010 Nov-Dec;16(6):48-54.
5. Li L and Ding J. J Tradit Chin Med. 2001 Mar;21(1):37-8.
6. Xiao XJ et al. J Integr Med. 2020 Jul;18(4):303-12.
7. Xu J et al. J Tradit Chin Med. 2013 Dec;33(6):752-6.
8. Yao J et al. Zhongguo Zhen Jiu. 2007; Jun;27(6):424-6.
9. Hon KL et al. Case Rep Pediatr. 2013;2013:605829.
10. Xing M et al. Medicine (Baltimore). 2020 Oct 9;99(41):e22539.
11. Kim TH et al. Eur J Integr Med. 2014 Aug 1;6(4):434-40.
12. Vender R and Vender R. J Cutan Med Surg. 2015 May-Jun;19(3):320-2.
13. Zhou Y et al. Biomed Opt Express. 2020 Apr 6;11(5):2394-401.
This article was updated 4/25/22.
My inspiration to write about cupping this month stems from the perception that everyone seems to be talking about it, from a facialist who suggested it for me to a coworker who swears by cupping to treat her allergies. Cupping is by no means a novel procedure. Its use as a health therapy dates back thousands of years to ancient Egypt (1500 BCE), ancient Greece (described by Hippocrates), ancient Rome (described by the Greek physician Galen), China (during the Han dynasty, 206 BCE to 220 CE) and traditional Islamic culture.1 Over the past decade, the popularity of this ancient procedure has been increasing in the United States.1 Cupping has been applied as a remedy for various dermatologic and medical conditions, including herpes zoster, headaches, diminished appetite, maldigestion, abscess evacuation, narcolepsy, pain, fever, dysmenorrhea, and gout.1,2
Theories on the mechanism(s) of action
The practice of cupping is differentiated into dry and wet cupping.1,2 Traditionally, with dry cupping, a flame is applied to heat the air inside a thick glass cup (rather than the cup itself).1 The cup is placed on the skin surface, and negative pressure suctions the skin into the cup. Wet cupping differs mainly from dry cupping in that it involves blood-letting. Cups made of either silicone or glass of varying size and shapes are used. Modern adaptations to cupping include needle, herbal, and pulsatile cupping, as well as a “moving cupping” technique (vs. traditionally stationary cups).1
There are several theories, many of which are derived from the nondermatologic literature (that is, pain management), as to how cupping may deliver a clinical benefit. Some theories are based in scientific and medical principles, whereas other theories are more whimsical – specifically, that cupping draws out evil spirits.2 Studies of dry cupping have suggested that the procedure results in increased oxygenation of muscles via a local increase in oxygenated hemoglobin, which may help improve muscular activity and reduce pain.1 As theorized by Lowe in 2017, negative pressure exerted by dry cupping leads to stretching and dilation of capillaries, which increases blood flow.3 Wet cupping has been shown to increase heat shock protein 70 (HSP70) and beta-endorphin expression in rat models, which is thought to facilitate pain management.1 Removal of oxidants and reduction of reactive oxygen species in the blood is believed to be among the benefits of wet cupping.1
Cupping in general dermatology
While , as well as various inflammatory conditions.
Herpes zoster
In 2010, Cao et al. reported on their systematic review of wet cupping after completing searches of multiple databases (that is, PubMed, the Cochrane Library [Issue 3, 2008], China Network Knowledge Infrastructure, Chinese Scientific Journal Database, and Wan Fang Database). They identified eight randomized controlled trials involving 651 patients, with meta-analyses revealing that wet cupping performed better than medications in terms of the number of “cured” patients, number of patients with improved symptoms, and a lower incidence of postherpetic neuralgia. Wet cupping, in addition to medication, was also found to be superior to medication alone in multiple patients. The researchers concluded that wet cupping appears to effectively treat herpes zoster.4 However, the study failed to identify which medications were used to treat herpes zoster. In the United States, common medications for herpes zoster include acyclovir, valacyclovir, steroids, gabapentin, and other neuromodulators. Without knowing which medications were used, it is difficult to compare cupping to medication in terms of efficacy in treating herpes zoster.
Urticaria
Urticaria (hives) is an inflammatory skin condition that can be very uncomfortable for patients but often resolves without intervention within several months after onset. In 2001, Li and Ding reported on the treatment with cupping of 40 patients with urticaria. The cure rate among the treatment group was cited as 55%, compared with 30% in the control group, who were treated with a traditional Chinese remedy and an unidentified first-generation antihistamine.1,5 In 2020, Xiao et al. conducted a systematic review and meta-analysis of cupping therapy for patients with chronic urticaria. They identified 13 comparisons from 12 randomized controlled trials involving 842 subjects. The investigators found no significant differences between wet cupping and medication usage. They also found that cupping combined with antihistamine treatment was superior to antihistamines alone, and cupping therapy with acupuncture was more effective than acupuncture alone. The investigators did call for caution, citing the poor quality of the studies reviewed.6
It is important to note that it is difficult to attribute resolution of urticaria to the use of cupping given the self-resolution often associated with this condition. Antihistamines are the mainstay of therapy for urticaria, but in my personal experience, patients are not entirely satisfied with the level of symptom control with antihistamines alone and often search for alternative therapies to control the pesky hives and associated itch. In 2014, omalizumab (Xolair) was approved for treating chronic idiopathic urticaria, which has helped patients control symptoms of chronic idiopathic urticaria without needing to take antihistamines. There was no indication that the studies reviewed by Xiao et al. compared cupping against this new effective treatment. Therefore, these studies comparing cupping to medical management are outdated.
Acne, eczema, and psoriasis
Soliman’s 2018 review of cupping in dermatology included a few studies on these common cutaneous conditions. For instance, a 2013 single-blind prospective study by Xu et al. reported on the results of patients with moderate acne who received wet cupping (in the form of prickling bloodletting) twice weekly for 6 weeks.7 They reported that patients demonstrated improvement in the global acne grading system (GAGS) score by the end of the trial.1,7 Unfortunately, cupping was not compared with standard acne treatments (that is, benzoyl peroxide, topical and oral antibiotics, isotretinoin, topical retinoids, spironolactone).
In evaluating cupping for acute eczema, wet cupping was compared with oral loratadine and topical ointments in a 2007 study by Yao and Li. They divided 88 cases into treatment and control groups, with the former group (n = 46) receiving bloodletting puncturing and cupping and the control group (n = 42) receiving oral loratadine and topical Pairuisong (an herbal ointment used in Chinese medicine). The investigators observed no significant difference in total effective rates but a superior difference in the rates of responses that were considered “cured” and “markedly effective” in favor of the cupping treatment.1,8 However, a case report by Hon et al. has indicated that cupping therapy may be associated with more harm than benefit when used as an eczema treatment.1,9
In addition, it is important to note that the past 5 years have been gamechanging in the management of chronic eczema in terms of the array of novel and effective therapies (e.g., dupilumab and JAK inhibitors) and chronic moderate-to-severe eczema has become very treatable. Similarly, acute eczema is often successfully managed with topical steroids, calcineurin inhibitors, and emollients. As such, there is no compelling reason to consider an unproven treatment such as cupping.
In 2020, Xing et al. reviewed 16 randomized controlled trials assessing the use of “moving cupping” for plaque psoriasis, with 1,164 patients meeting inclusion criteria. Moving cupping was found to be significantly more effective than “no-moving” cupping therapy, and moving cupping, combined with medications, performed better than medications alone.10 None of the trials evaluated in this study included randomized controlled trials that compared patients using any of the more modern psoriasis medications, specifically biologics. And, again, the studies evaluated were not of the highest quality.
The data that support cupping, as summarized above, are based mostly on case reports, and strong double-blind prospective studies are lacking. Additionally, most of the studies cited gauged the efficacy of cupping using qualitative endpoints, rather than standardized quantitative endpoints and scales. Moreover, spontaneous remission of various dermatoses can occur, or they can improve over time, including acute eczema, psoriasis, and, especially, urticaria.
Adverse effects of cupping
Often alternative therapies are seen as “benign” and without adverse effects. However, complications can result from cupping. Trauma can be induced from the cupping itself by damaging superficial blood vessels and causing bruising.1,11 Blistering can also occur secondary to the suction effect, and the epidermal and dermal layers of the skin can be separated.1,11 Further, burns and discoloration have also been noted secondary to heat, trauma, and post inflammatory pigmentary changes.1,11 Another risk of cupping is the Koebner phenomenon, which occurs with psoriasis, with new lesions appearing in traumatized skin.12 Other adverse outcomes that have been reported with cupping include reactivation of herpes simplex virus secondary to skin trauma, iron deficiency anemia (secondary to blood loss), panniculitis, infections, and residual marks mistaken for signs of child abuse.1,11
Cupping in aesthetic dermatology
Facial cupping, a distinct practice from body cupping used to treat general dermatology conditions described previously, is also increasing in popularity. This practice is usually conducted in association with a facial or facial acupuncture by an aesthetician or other licensed professional. It can also be performed using at-home kits. The marketing claims for facial cupping cite improved tightening and contouring of facial skin, increased facial microcirculation and collagen synthesis, and enhanced lymphatic flow to aid with facial puffiness or swelling. One supposed mechanism for these benefits is that cupping increases blood flow. Interestingly, there was a 2020 animal study in which photoacoustic imaging of a mouse ear revealed increased temporary blood flow in the cupping microenvironment.13 Currently, however, there is no evidence in the English scientific literature that supports facial cupping. The benefits attributed to facial cupping for aesthetic purposes have emerged only in personal anecdotes. The temporary increase in blood flow may induce inflammation and swelling that adds volume to the face and temporarily diminishes wrinkles. However, this temporary plumpness may be associated with adverse effects, such as local trauma, irritation, bruising, postinflammatory pigmentary alteration, or even herpes reactivation. In my opinion, the possible adverse effects of cupping outweigh any potential benefit, especially given the insufficient evidence supporting the utility of cupping for cosmetic enhancement.
Summary
There is increasing interest among patients to incorporate complementary and alternative medicine – including the ancient tradition of cupping – in managing medical dermatologic conditions. However, current evidence supporting cupping as an effective therapeutic strategy is not strong, with most studies to date appearing to be of poor quality or not sufficiently convincing to displace standard therapies. Our medical strategies for managing chronic dermatologic conditions, particularly inflammatory disorders, continue to improve from both a safety and a proven efficacy standpoint. Therefore, I would not forgo medical management in favor of cupping. While cupping can be used as an adjunct therapy, I would caution patients about possible adverse side effects. In the aesthetic world, cupping is also gaining popularity, but this trend is also not supported by current evidence or studies, at least in the Western literature.
Dr. Goldman is a dermatologist in private practice in Miami and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a general dermatology practice. Write to her at [email protected] or message her on Instragram @DrChloeGoldman. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other disclosures.
References
1. Soliman Y et al. Acta Dermatovenerol Alp Pannonica Adriat. 2018 Jun;27(2):103-7.
2. França K and Lotti T. Advances in Integrative Dermatology. John Wiley & Sons, 2019.
3. Lowe DT. Complement Ther Clin Pract. 2017 Nov;29:162-8.
4.Cao H et al. Altern Ther Health Med. 2010 Nov-Dec;16(6):48-54.
5. Li L and Ding J. J Tradit Chin Med. 2001 Mar;21(1):37-8.
6. Xiao XJ et al. J Integr Med. 2020 Jul;18(4):303-12.
7. Xu J et al. J Tradit Chin Med. 2013 Dec;33(6):752-6.
8. Yao J et al. Zhongguo Zhen Jiu. 2007; Jun;27(6):424-6.
9. Hon KL et al. Case Rep Pediatr. 2013;2013:605829.
10. Xing M et al. Medicine (Baltimore). 2020 Oct 9;99(41):e22539.
11. Kim TH et al. Eur J Integr Med. 2014 Aug 1;6(4):434-40.
12. Vender R and Vender R. J Cutan Med Surg. 2015 May-Jun;19(3):320-2.
13. Zhou Y et al. Biomed Opt Express. 2020 Apr 6;11(5):2394-401.
This article was updated 4/25/22.
My inspiration to write about cupping this month stems from the perception that everyone seems to be talking about it, from a facialist who suggested it for me to a coworker who swears by cupping to treat her allergies. Cupping is by no means a novel procedure. Its use as a health therapy dates back thousands of years to ancient Egypt (1500 BCE), ancient Greece (described by Hippocrates), ancient Rome (described by the Greek physician Galen), China (during the Han dynasty, 206 BCE to 220 CE) and traditional Islamic culture.1 Over the past decade, the popularity of this ancient procedure has been increasing in the United States.1 Cupping has been applied as a remedy for various dermatologic and medical conditions, including herpes zoster, headaches, diminished appetite, maldigestion, abscess evacuation, narcolepsy, pain, fever, dysmenorrhea, and gout.1,2
Theories on the mechanism(s) of action
The practice of cupping is differentiated into dry and wet cupping.1,2 Traditionally, with dry cupping, a flame is applied to heat the air inside a thick glass cup (rather than the cup itself).1 The cup is placed on the skin surface, and negative pressure suctions the skin into the cup. Wet cupping differs mainly from dry cupping in that it involves blood-letting. Cups made of either silicone or glass of varying size and shapes are used. Modern adaptations to cupping include needle, herbal, and pulsatile cupping, as well as a “moving cupping” technique (vs. traditionally stationary cups).1
There are several theories, many of which are derived from the nondermatologic literature (that is, pain management), as to how cupping may deliver a clinical benefit. Some theories are based in scientific and medical principles, whereas other theories are more whimsical – specifically, that cupping draws out evil spirits.2 Studies of dry cupping have suggested that the procedure results in increased oxygenation of muscles via a local increase in oxygenated hemoglobin, which may help improve muscular activity and reduce pain.1 As theorized by Lowe in 2017, negative pressure exerted by dry cupping leads to stretching and dilation of capillaries, which increases blood flow.3 Wet cupping has been shown to increase heat shock protein 70 (HSP70) and beta-endorphin expression in rat models, which is thought to facilitate pain management.1 Removal of oxidants and reduction of reactive oxygen species in the blood is believed to be among the benefits of wet cupping.1
Cupping in general dermatology
While , as well as various inflammatory conditions.
Herpes zoster
In 2010, Cao et al. reported on their systematic review of wet cupping after completing searches of multiple databases (that is, PubMed, the Cochrane Library [Issue 3, 2008], China Network Knowledge Infrastructure, Chinese Scientific Journal Database, and Wan Fang Database). They identified eight randomized controlled trials involving 651 patients, with meta-analyses revealing that wet cupping performed better than medications in terms of the number of “cured” patients, number of patients with improved symptoms, and a lower incidence of postherpetic neuralgia. Wet cupping, in addition to medication, was also found to be superior to medication alone in multiple patients. The researchers concluded that wet cupping appears to effectively treat herpes zoster.4 However, the study failed to identify which medications were used to treat herpes zoster. In the United States, common medications for herpes zoster include acyclovir, valacyclovir, steroids, gabapentin, and other neuromodulators. Without knowing which medications were used, it is difficult to compare cupping to medication in terms of efficacy in treating herpes zoster.
Urticaria
Urticaria (hives) is an inflammatory skin condition that can be very uncomfortable for patients but often resolves without intervention within several months after onset. In 2001, Li and Ding reported on the treatment with cupping of 40 patients with urticaria. The cure rate among the treatment group was cited as 55%, compared with 30% in the control group, who were treated with a traditional Chinese remedy and an unidentified first-generation antihistamine.1,5 In 2020, Xiao et al. conducted a systematic review and meta-analysis of cupping therapy for patients with chronic urticaria. They identified 13 comparisons from 12 randomized controlled trials involving 842 subjects. The investigators found no significant differences between wet cupping and medication usage. They also found that cupping combined with antihistamine treatment was superior to antihistamines alone, and cupping therapy with acupuncture was more effective than acupuncture alone. The investigators did call for caution, citing the poor quality of the studies reviewed.6
It is important to note that it is difficult to attribute resolution of urticaria to the use of cupping given the self-resolution often associated with this condition. Antihistamines are the mainstay of therapy for urticaria, but in my personal experience, patients are not entirely satisfied with the level of symptom control with antihistamines alone and often search for alternative therapies to control the pesky hives and associated itch. In 2014, omalizumab (Xolair) was approved for treating chronic idiopathic urticaria, which has helped patients control symptoms of chronic idiopathic urticaria without needing to take antihistamines. There was no indication that the studies reviewed by Xiao et al. compared cupping against this new effective treatment. Therefore, these studies comparing cupping to medical management are outdated.
Acne, eczema, and psoriasis
Soliman’s 2018 review of cupping in dermatology included a few studies on these common cutaneous conditions. For instance, a 2013 single-blind prospective study by Xu et al. reported on the results of patients with moderate acne who received wet cupping (in the form of prickling bloodletting) twice weekly for 6 weeks.7 They reported that patients demonstrated improvement in the global acne grading system (GAGS) score by the end of the trial.1,7 Unfortunately, cupping was not compared with standard acne treatments (that is, benzoyl peroxide, topical and oral antibiotics, isotretinoin, topical retinoids, spironolactone).
In evaluating cupping for acute eczema, wet cupping was compared with oral loratadine and topical ointments in a 2007 study by Yao and Li. They divided 88 cases into treatment and control groups, with the former group (n = 46) receiving bloodletting puncturing and cupping and the control group (n = 42) receiving oral loratadine and topical Pairuisong (an herbal ointment used in Chinese medicine). The investigators observed no significant difference in total effective rates but a superior difference in the rates of responses that were considered “cured” and “markedly effective” in favor of the cupping treatment.1,8 However, a case report by Hon et al. has indicated that cupping therapy may be associated with more harm than benefit when used as an eczema treatment.1,9
In addition, it is important to note that the past 5 years have been gamechanging in the management of chronic eczema in terms of the array of novel and effective therapies (e.g., dupilumab and JAK inhibitors) and chronic moderate-to-severe eczema has become very treatable. Similarly, acute eczema is often successfully managed with topical steroids, calcineurin inhibitors, and emollients. As such, there is no compelling reason to consider an unproven treatment such as cupping.
In 2020, Xing et al. reviewed 16 randomized controlled trials assessing the use of “moving cupping” for plaque psoriasis, with 1,164 patients meeting inclusion criteria. Moving cupping was found to be significantly more effective than “no-moving” cupping therapy, and moving cupping, combined with medications, performed better than medications alone.10 None of the trials evaluated in this study included randomized controlled trials that compared patients using any of the more modern psoriasis medications, specifically biologics. And, again, the studies evaluated were not of the highest quality.
The data that support cupping, as summarized above, are based mostly on case reports, and strong double-blind prospective studies are lacking. Additionally, most of the studies cited gauged the efficacy of cupping using qualitative endpoints, rather than standardized quantitative endpoints and scales. Moreover, spontaneous remission of various dermatoses can occur, or they can improve over time, including acute eczema, psoriasis, and, especially, urticaria.
Adverse effects of cupping
Often alternative therapies are seen as “benign” and without adverse effects. However, complications can result from cupping. Trauma can be induced from the cupping itself by damaging superficial blood vessels and causing bruising.1,11 Blistering can also occur secondary to the suction effect, and the epidermal and dermal layers of the skin can be separated.1,11 Further, burns and discoloration have also been noted secondary to heat, trauma, and post inflammatory pigmentary changes.1,11 Another risk of cupping is the Koebner phenomenon, which occurs with psoriasis, with new lesions appearing in traumatized skin.12 Other adverse outcomes that have been reported with cupping include reactivation of herpes simplex virus secondary to skin trauma, iron deficiency anemia (secondary to blood loss), panniculitis, infections, and residual marks mistaken for signs of child abuse.1,11
Cupping in aesthetic dermatology
Facial cupping, a distinct practice from body cupping used to treat general dermatology conditions described previously, is also increasing in popularity. This practice is usually conducted in association with a facial or facial acupuncture by an aesthetician or other licensed professional. It can also be performed using at-home kits. The marketing claims for facial cupping cite improved tightening and contouring of facial skin, increased facial microcirculation and collagen synthesis, and enhanced lymphatic flow to aid with facial puffiness or swelling. One supposed mechanism for these benefits is that cupping increases blood flow. Interestingly, there was a 2020 animal study in which photoacoustic imaging of a mouse ear revealed increased temporary blood flow in the cupping microenvironment.13 Currently, however, there is no evidence in the English scientific literature that supports facial cupping. The benefits attributed to facial cupping for aesthetic purposes have emerged only in personal anecdotes. The temporary increase in blood flow may induce inflammation and swelling that adds volume to the face and temporarily diminishes wrinkles. However, this temporary plumpness may be associated with adverse effects, such as local trauma, irritation, bruising, postinflammatory pigmentary alteration, or even herpes reactivation. In my opinion, the possible adverse effects of cupping outweigh any potential benefit, especially given the insufficient evidence supporting the utility of cupping for cosmetic enhancement.
Summary
There is increasing interest among patients to incorporate complementary and alternative medicine – including the ancient tradition of cupping – in managing medical dermatologic conditions. However, current evidence supporting cupping as an effective therapeutic strategy is not strong, with most studies to date appearing to be of poor quality or not sufficiently convincing to displace standard therapies. Our medical strategies for managing chronic dermatologic conditions, particularly inflammatory disorders, continue to improve from both a safety and a proven efficacy standpoint. Therefore, I would not forgo medical management in favor of cupping. While cupping can be used as an adjunct therapy, I would caution patients about possible adverse side effects. In the aesthetic world, cupping is also gaining popularity, but this trend is also not supported by current evidence or studies, at least in the Western literature.
Dr. Goldman is a dermatologist in private practice in Miami and specializes in cosmetic and general dermatology. She practices at Baumann Cosmetic & Research Institute and is also opening a general dermatology practice. Write to her at [email protected] or message her on Instragram @DrChloeGoldman. Dr. Goldman receives compensation to create social media content for Replenix, a skin care company. She has no other disclosures.
References
1. Soliman Y et al. Acta Dermatovenerol Alp Pannonica Adriat. 2018 Jun;27(2):103-7.
2. França K and Lotti T. Advances in Integrative Dermatology. John Wiley & Sons, 2019.
3. Lowe DT. Complement Ther Clin Pract. 2017 Nov;29:162-8.
4.Cao H et al. Altern Ther Health Med. 2010 Nov-Dec;16(6):48-54.
5. Li L and Ding J. J Tradit Chin Med. 2001 Mar;21(1):37-8.
6. Xiao XJ et al. J Integr Med. 2020 Jul;18(4):303-12.
7. Xu J et al. J Tradit Chin Med. 2013 Dec;33(6):752-6.
8. Yao J et al. Zhongguo Zhen Jiu. 2007; Jun;27(6):424-6.
9. Hon KL et al. Case Rep Pediatr. 2013;2013:605829.
10. Xing M et al. Medicine (Baltimore). 2020 Oct 9;99(41):e22539.
11. Kim TH et al. Eur J Integr Med. 2014 Aug 1;6(4):434-40.
12. Vender R and Vender R. J Cutan Med Surg. 2015 May-Jun;19(3):320-2.
13. Zhou Y et al. Biomed Opt Express. 2020 Apr 6;11(5):2394-401.
This article was updated 4/25/22.
Sustained jawline definition from hyaluronic gel, study reports
BOSTON – After several promising early phase studies, from what study authors characterized as a “pivotal” randomized multicenter trial. The results were presented during a late-breaking research session at the annual meeting of the American Academy of Dermatology.
The primary outcome, assessed at 6 months, was at least a 1-point improvement in a photonumeric scale used to grade jawline sagging, reported Jeremy Green, MD, Skin Associates of South Florida, Coral Gables.
When those randomized to the hyaluronic filler gel VYC-25L (Vycross, Juvéderm) were compared with untreated controls, 68.5% versus 38.4% met the criterion for benefit at 6 months. Importantly, the effect in treated patients was sustained when reevaluated at 12 months. Green reported that the response is generally sustained at the maximum follow-up, now out to 17 months.
Most enrolled patients are severely affected
In this study, 208 patients with severe (74%) or moderate loss of jawline definition were randomized in a 3:1 ratio to receive the filler or serve as controls. The initially untreated controls received the gel after the primary outcome analysis at 6 months.
The hyaluronic gel was injected at five sites along the jawline. The mean age of participants was 58 years. The majority were women, and most were White.
Dermatologists blinded to treatment compared photos at 6 months with those taken at baseline using the photonumeric grading system of 1-5. Change in patient satisfaction at 6 months and again at 12 months relative to baseline was also evaluated.
From baseline, when 28.9% of participants reported satisfaction on the Global Aesthetic Improvement Scale (GAIS), rates rose to 89.0% at month 6. There was a decline at month 12, but 79.9% remained satisfied after this period of follow-up.
Most patients experienced injection site reactions that were mainly mild to moderate and all resolved within several days of treatment. Pain with mastication was initially reported by 1.9%, but again this complaint was also mild and transient. All complaints had largely resolved by day 3.
The results are consistent with several previous clinical studies of VYC-25L for the same indication. In a similarly designed trial conducted in Europe that also used a 3:1 randomization scheme, the primary outcome assessed at 3 months was change in facial angle. Relative to controls, the angle improved by 2.51 degrees (P < .0001).
Patient satisfaction supports filler benefit
In the similar European trial, the clinical significance of the objective primary outcome also was supported by patient satisfaction assessed with several instruments, including the GAIS. Some degree of swelling or tenderness was experienced by almost all patients after injection, but none were serious, and all resolved.
In another trial, 202 patients with chin retrusion were randomized in a 3:1 ratio to VYC-25L or a control group. In that study, the primary outcome was at least a 1-point improvement in the Allergan Chin Retrusion Scale at 6 months. This advantage for treatment (56.3% vs. 27.5%) was again supported by several instruments for evaluating patient satisfaction, including GAIS.
As in the other studies, most patients had injection site reactions. Although all resolved within days of treatment, one patient left the study after experiencing cellulitis and injection-site inflammation.
Dissatisfaction with jawline definition is a relatively common complaint in Dr. Green’s experience, who said that there is a need for more effective and well-tolerated treatments. Given the efficacy, tolerability, and safety of VYC-25L in this controlled study, he suggested this product has potential utility.
In the field of cosmetic dermatology, there appears to be incremental progress in fillers with favorable clinical characteristics, according to Sandy U. Tsao, MD, a dermatologic surgeon at Massachusetts General Hospital, Boston.
“We are seeing filler lasting longer and longer,” she said, commenting specifically about the results presented by Dr. Green. She called sustained aesthetic improvement at 12 months for the filler in this study “really exciting.”
Dr. Green has reported financial relationships with numerous pharmaceutical companies. Dr. Tsao has reported financial relationships with Epiphany Dermatology, Lazarus AI, and UpToDate.
A version of this article first appeared on Medscape.com.
BOSTON – After several promising early phase studies, from what study authors characterized as a “pivotal” randomized multicenter trial. The results were presented during a late-breaking research session at the annual meeting of the American Academy of Dermatology.
The primary outcome, assessed at 6 months, was at least a 1-point improvement in a photonumeric scale used to grade jawline sagging, reported Jeremy Green, MD, Skin Associates of South Florida, Coral Gables.
When those randomized to the hyaluronic filler gel VYC-25L (Vycross, Juvéderm) were compared with untreated controls, 68.5% versus 38.4% met the criterion for benefit at 6 months. Importantly, the effect in treated patients was sustained when reevaluated at 12 months. Green reported that the response is generally sustained at the maximum follow-up, now out to 17 months.
Most enrolled patients are severely affected
In this study, 208 patients with severe (74%) or moderate loss of jawline definition were randomized in a 3:1 ratio to receive the filler or serve as controls. The initially untreated controls received the gel after the primary outcome analysis at 6 months.
The hyaluronic gel was injected at five sites along the jawline. The mean age of participants was 58 years. The majority were women, and most were White.
Dermatologists blinded to treatment compared photos at 6 months with those taken at baseline using the photonumeric grading system of 1-5. Change in patient satisfaction at 6 months and again at 12 months relative to baseline was also evaluated.
From baseline, when 28.9% of participants reported satisfaction on the Global Aesthetic Improvement Scale (GAIS), rates rose to 89.0% at month 6. There was a decline at month 12, but 79.9% remained satisfied after this period of follow-up.
Most patients experienced injection site reactions that were mainly mild to moderate and all resolved within several days of treatment. Pain with mastication was initially reported by 1.9%, but again this complaint was also mild and transient. All complaints had largely resolved by day 3.
The results are consistent with several previous clinical studies of VYC-25L for the same indication. In a similarly designed trial conducted in Europe that also used a 3:1 randomization scheme, the primary outcome assessed at 3 months was change in facial angle. Relative to controls, the angle improved by 2.51 degrees (P < .0001).
Patient satisfaction supports filler benefit
In the similar European trial, the clinical significance of the objective primary outcome also was supported by patient satisfaction assessed with several instruments, including the GAIS. Some degree of swelling or tenderness was experienced by almost all patients after injection, but none were serious, and all resolved.
In another trial, 202 patients with chin retrusion were randomized in a 3:1 ratio to VYC-25L or a control group. In that study, the primary outcome was at least a 1-point improvement in the Allergan Chin Retrusion Scale at 6 months. This advantage for treatment (56.3% vs. 27.5%) was again supported by several instruments for evaluating patient satisfaction, including GAIS.
As in the other studies, most patients had injection site reactions. Although all resolved within days of treatment, one patient left the study after experiencing cellulitis and injection-site inflammation.
Dissatisfaction with jawline definition is a relatively common complaint in Dr. Green’s experience, who said that there is a need for more effective and well-tolerated treatments. Given the efficacy, tolerability, and safety of VYC-25L in this controlled study, he suggested this product has potential utility.
In the field of cosmetic dermatology, there appears to be incremental progress in fillers with favorable clinical characteristics, according to Sandy U. Tsao, MD, a dermatologic surgeon at Massachusetts General Hospital, Boston.
“We are seeing filler lasting longer and longer,” she said, commenting specifically about the results presented by Dr. Green. She called sustained aesthetic improvement at 12 months for the filler in this study “really exciting.”
Dr. Green has reported financial relationships with numerous pharmaceutical companies. Dr. Tsao has reported financial relationships with Epiphany Dermatology, Lazarus AI, and UpToDate.
A version of this article first appeared on Medscape.com.
BOSTON – After several promising early phase studies, from what study authors characterized as a “pivotal” randomized multicenter trial. The results were presented during a late-breaking research session at the annual meeting of the American Academy of Dermatology.
The primary outcome, assessed at 6 months, was at least a 1-point improvement in a photonumeric scale used to grade jawline sagging, reported Jeremy Green, MD, Skin Associates of South Florida, Coral Gables.
When those randomized to the hyaluronic filler gel VYC-25L (Vycross, Juvéderm) were compared with untreated controls, 68.5% versus 38.4% met the criterion for benefit at 6 months. Importantly, the effect in treated patients was sustained when reevaluated at 12 months. Green reported that the response is generally sustained at the maximum follow-up, now out to 17 months.
Most enrolled patients are severely affected
In this study, 208 patients with severe (74%) or moderate loss of jawline definition were randomized in a 3:1 ratio to receive the filler or serve as controls. The initially untreated controls received the gel after the primary outcome analysis at 6 months.
The hyaluronic gel was injected at five sites along the jawline. The mean age of participants was 58 years. The majority were women, and most were White.
Dermatologists blinded to treatment compared photos at 6 months with those taken at baseline using the photonumeric grading system of 1-5. Change in patient satisfaction at 6 months and again at 12 months relative to baseline was also evaluated.
From baseline, when 28.9% of participants reported satisfaction on the Global Aesthetic Improvement Scale (GAIS), rates rose to 89.0% at month 6. There was a decline at month 12, but 79.9% remained satisfied after this period of follow-up.
Most patients experienced injection site reactions that were mainly mild to moderate and all resolved within several days of treatment. Pain with mastication was initially reported by 1.9%, but again this complaint was also mild and transient. All complaints had largely resolved by day 3.
The results are consistent with several previous clinical studies of VYC-25L for the same indication. In a similarly designed trial conducted in Europe that also used a 3:1 randomization scheme, the primary outcome assessed at 3 months was change in facial angle. Relative to controls, the angle improved by 2.51 degrees (P < .0001).
Patient satisfaction supports filler benefit
In the similar European trial, the clinical significance of the objective primary outcome also was supported by patient satisfaction assessed with several instruments, including the GAIS. Some degree of swelling or tenderness was experienced by almost all patients after injection, but none were serious, and all resolved.
In another trial, 202 patients with chin retrusion were randomized in a 3:1 ratio to VYC-25L or a control group. In that study, the primary outcome was at least a 1-point improvement in the Allergan Chin Retrusion Scale at 6 months. This advantage for treatment (56.3% vs. 27.5%) was again supported by several instruments for evaluating patient satisfaction, including GAIS.
As in the other studies, most patients had injection site reactions. Although all resolved within days of treatment, one patient left the study after experiencing cellulitis and injection-site inflammation.
Dissatisfaction with jawline definition is a relatively common complaint in Dr. Green’s experience, who said that there is a need for more effective and well-tolerated treatments. Given the efficacy, tolerability, and safety of VYC-25L in this controlled study, he suggested this product has potential utility.
In the field of cosmetic dermatology, there appears to be incremental progress in fillers with favorable clinical characteristics, according to Sandy U. Tsao, MD, a dermatologic surgeon at Massachusetts General Hospital, Boston.
“We are seeing filler lasting longer and longer,” she said, commenting specifically about the results presented by Dr. Green. She called sustained aesthetic improvement at 12 months for the filler in this study “really exciting.”
Dr. Green has reported financial relationships with numerous pharmaceutical companies. Dr. Tsao has reported financial relationships with Epiphany Dermatology, Lazarus AI, and UpToDate.
A version of this article first appeared on Medscape.com.
AT AAD 2022
Platelet-rich plasma for hair regrowth requires art and science
or administer the highly technique-dependent treatment, which creates plenty of room for suboptimal results, according to several experts at the annual meeting of the American Academy of Dermatology.
“The process is the product,” emphasized Terrence Keaney, MD, clinical associate professor at George Washington University, Washington, as well as cofounder of SkinDC, a private practice in Arlington, Va. He characterized PRP as a “growth factor cytokine cocktail,” for which relative benefits are fully dependent on the ingredients.
In other words, the efficacy of PRP is mostly dependent on the multiple steps in which blood drawn from a patient is separated into its components, processed to create a platelet-rich product, and then administered to the patient by injection or in conjunction with microneedles. While the goal is a platelet concentration two- to fivefold greater than that found in whole blood, this is not as straightforward as it sounds.
Many PRP device kits available
“There are a ton of [centrifuge] devices on the market and a lot of differences in the methodology in optimizing the platelet concentration,” Dr. Keaney explained. In addition, there are numerous proprietary collection tubes using different types of anticoagulants and different separator gels that also play a role in the goal of optimizing a platelet-rich and readily activated product.
“Recognize that each step in the preparation of PRP introduces a source of variation that affects the composition and efficacy of the final product,” said Steven Krueger, MD, who is completing his residency in dermatology at the University of Massachusetts, Worcester, but who has become an expert in the field. He contributed a chapter on this topic in the recently published book, Aesthetic Clinician’s Guide to Platelet Rich Plasma.
The importance of technique is reflected in inconsistent results from published controlled trials. Unfortunately, the authors of many studies have failed to provide details of their protocol. Ultimately, Dr. Krueger said this lack of clarity among available protocols has created a serious obstacle for establishing which steps are important and how to move the field forward.
Dr. Keaney agreed. Because of the frequent lack of details about how PRP was processed in available studies, the effort to draw conclusions about the experiences at different centers is like “comparing apples to oranges.”
“What is the ideal dose and concentrate? We don’t know,” Dr. Keaney said.
The first centrifuge device to receive regulatory approval was developed for orthopedic indications more than 20 years ago. There are now at least 20 centrifuge devices with 510K Food and Drug Administration clearance for separating blood components to produce PRP. The 510K designation means that they are “substantially equivalent” to an already approved device, but Dr. Krueger cautioned that their use in preparing PRP for treatment of hair loss remains off label.
Substandard devices are marketed
In the rapidly expanding world of PRP, there is also a growing array of PRP kits. Some of these kits have been cleared by the FDA but others have not. Dr. Krueger warned that collection tubes are being marketed that are substandard imitations of better-established products. He specifically cautioned against do-it-yourself PRP kits, which are likely to be less effective for isolating platelets and can also be contaminated with pyogenes that cause infection.
“Please use an FDA-cleared kit,” he said, warning that the risk of failing to do so is not just associated with lack of efficacy but also a significant risk of serious adverse events.
Of the centrifuge devices, both Dr. Krueger and Dr. Keaney generally recommend single-spin over double-spin devices, particularly at centers with a limited volume of PRP-based hair loss interventions. These are generally simpler.
Once the PRP has been properly prepared, the efficacy of PRP upon application can also be influenced by strategies for activation. Although the exact mechanism of PRP in stimulating hair growth is incompletely defined, the role of platelets in releasing growth factors is believed to be critical. There are a number of methods to stimulate platelets upon administration, such as exposure to endogenous collagen or thrombin or exogenous chemicals, such as calcium chloride, but again, techniques differ and the optimal approach is unknown.
One concern is the recent and largely unregulated growth of regenerative cell and tissue products for treating a large array of clinical disorders or cosmetic issues, according to Dr. Keaney. He warned of a “wild, wild west mentality” that has attracted providers with inadequate training and experience. In turn, this is now attracting the attention of the FDA as well as those involved in enforcing FDA directives.
“There is definitely more scrutiny of regenerative products,” he said, noting that he is careful about how he markets PRP. While it is reasonable to offer this off-label treatment as an in-office procedure, he noted that it is illegal to advertise off-label products. He reported that he has become more prudent when including this option among hair regrowth services provided in his practice.
Omer E. Ibrahim, MD, a dermatologist affiliated with Chicago Cosmetic Surgery and Dermatology, agreed. While he also feels there is good evidence to support PRP as a hair loss treatment option, particularly for androgenic alopecia, he also expressed caution about promoting this approach in exclusion of other options.
“Patients ask me for a PRP consultation, but there is no such thing as a PRP consultation in my practice,” Dr. Ibrahim said. He incorporates PRP into other strategies. “I stress that it is one part of a multipronged approach,” he added.
Dr. Ibrahim has reported financial relationships with Alastin Skincare, Allergan, Eclipse Medical, Galderma USA, and Revision Skincare. Dr. Keaney has reported financial relationships with Allergan, DermTech, Evolus, Galderma USA, Merz Aesthetics, Revance Therapeutics, and Syneron Candela. Dr. Krueger has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
or administer the highly technique-dependent treatment, which creates plenty of room for suboptimal results, according to several experts at the annual meeting of the American Academy of Dermatology.
“The process is the product,” emphasized Terrence Keaney, MD, clinical associate professor at George Washington University, Washington, as well as cofounder of SkinDC, a private practice in Arlington, Va. He characterized PRP as a “growth factor cytokine cocktail,” for which relative benefits are fully dependent on the ingredients.
In other words, the efficacy of PRP is mostly dependent on the multiple steps in which blood drawn from a patient is separated into its components, processed to create a platelet-rich product, and then administered to the patient by injection or in conjunction with microneedles. While the goal is a platelet concentration two- to fivefold greater than that found in whole blood, this is not as straightforward as it sounds.
Many PRP device kits available
“There are a ton of [centrifuge] devices on the market and a lot of differences in the methodology in optimizing the platelet concentration,” Dr. Keaney explained. In addition, there are numerous proprietary collection tubes using different types of anticoagulants and different separator gels that also play a role in the goal of optimizing a platelet-rich and readily activated product.
“Recognize that each step in the preparation of PRP introduces a source of variation that affects the composition and efficacy of the final product,” said Steven Krueger, MD, who is completing his residency in dermatology at the University of Massachusetts, Worcester, but who has become an expert in the field. He contributed a chapter on this topic in the recently published book, Aesthetic Clinician’s Guide to Platelet Rich Plasma.
The importance of technique is reflected in inconsistent results from published controlled trials. Unfortunately, the authors of many studies have failed to provide details of their protocol. Ultimately, Dr. Krueger said this lack of clarity among available protocols has created a serious obstacle for establishing which steps are important and how to move the field forward.
Dr. Keaney agreed. Because of the frequent lack of details about how PRP was processed in available studies, the effort to draw conclusions about the experiences at different centers is like “comparing apples to oranges.”
“What is the ideal dose and concentrate? We don’t know,” Dr. Keaney said.
The first centrifuge device to receive regulatory approval was developed for orthopedic indications more than 20 years ago. There are now at least 20 centrifuge devices with 510K Food and Drug Administration clearance for separating blood components to produce PRP. The 510K designation means that they are “substantially equivalent” to an already approved device, but Dr. Krueger cautioned that their use in preparing PRP for treatment of hair loss remains off label.
Substandard devices are marketed
In the rapidly expanding world of PRP, there is also a growing array of PRP kits. Some of these kits have been cleared by the FDA but others have not. Dr. Krueger warned that collection tubes are being marketed that are substandard imitations of better-established products. He specifically cautioned against do-it-yourself PRP kits, which are likely to be less effective for isolating platelets and can also be contaminated with pyogenes that cause infection.
“Please use an FDA-cleared kit,” he said, warning that the risk of failing to do so is not just associated with lack of efficacy but also a significant risk of serious adverse events.
Of the centrifuge devices, both Dr. Krueger and Dr. Keaney generally recommend single-spin over double-spin devices, particularly at centers with a limited volume of PRP-based hair loss interventions. These are generally simpler.
Once the PRP has been properly prepared, the efficacy of PRP upon application can also be influenced by strategies for activation. Although the exact mechanism of PRP in stimulating hair growth is incompletely defined, the role of platelets in releasing growth factors is believed to be critical. There are a number of methods to stimulate platelets upon administration, such as exposure to endogenous collagen or thrombin or exogenous chemicals, such as calcium chloride, but again, techniques differ and the optimal approach is unknown.
One concern is the recent and largely unregulated growth of regenerative cell and tissue products for treating a large array of clinical disorders or cosmetic issues, according to Dr. Keaney. He warned of a “wild, wild west mentality” that has attracted providers with inadequate training and experience. In turn, this is now attracting the attention of the FDA as well as those involved in enforcing FDA directives.
“There is definitely more scrutiny of regenerative products,” he said, noting that he is careful about how he markets PRP. While it is reasonable to offer this off-label treatment as an in-office procedure, he noted that it is illegal to advertise off-label products. He reported that he has become more prudent when including this option among hair regrowth services provided in his practice.
Omer E. Ibrahim, MD, a dermatologist affiliated with Chicago Cosmetic Surgery and Dermatology, agreed. While he also feels there is good evidence to support PRP as a hair loss treatment option, particularly for androgenic alopecia, he also expressed caution about promoting this approach in exclusion of other options.
“Patients ask me for a PRP consultation, but there is no such thing as a PRP consultation in my practice,” Dr. Ibrahim said. He incorporates PRP into other strategies. “I stress that it is one part of a multipronged approach,” he added.
Dr. Ibrahim has reported financial relationships with Alastin Skincare, Allergan, Eclipse Medical, Galderma USA, and Revision Skincare. Dr. Keaney has reported financial relationships with Allergan, DermTech, Evolus, Galderma USA, Merz Aesthetics, Revance Therapeutics, and Syneron Candela. Dr. Krueger has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
or administer the highly technique-dependent treatment, which creates plenty of room for suboptimal results, according to several experts at the annual meeting of the American Academy of Dermatology.
“The process is the product,” emphasized Terrence Keaney, MD, clinical associate professor at George Washington University, Washington, as well as cofounder of SkinDC, a private practice in Arlington, Va. He characterized PRP as a “growth factor cytokine cocktail,” for which relative benefits are fully dependent on the ingredients.
In other words, the efficacy of PRP is mostly dependent on the multiple steps in which blood drawn from a patient is separated into its components, processed to create a platelet-rich product, and then administered to the patient by injection or in conjunction with microneedles. While the goal is a platelet concentration two- to fivefold greater than that found in whole blood, this is not as straightforward as it sounds.
Many PRP device kits available
“There are a ton of [centrifuge] devices on the market and a lot of differences in the methodology in optimizing the platelet concentration,” Dr. Keaney explained. In addition, there are numerous proprietary collection tubes using different types of anticoagulants and different separator gels that also play a role in the goal of optimizing a platelet-rich and readily activated product.
“Recognize that each step in the preparation of PRP introduces a source of variation that affects the composition and efficacy of the final product,” said Steven Krueger, MD, who is completing his residency in dermatology at the University of Massachusetts, Worcester, but who has become an expert in the field. He contributed a chapter on this topic in the recently published book, Aesthetic Clinician’s Guide to Platelet Rich Plasma.
The importance of technique is reflected in inconsistent results from published controlled trials. Unfortunately, the authors of many studies have failed to provide details of their protocol. Ultimately, Dr. Krueger said this lack of clarity among available protocols has created a serious obstacle for establishing which steps are important and how to move the field forward.
Dr. Keaney agreed. Because of the frequent lack of details about how PRP was processed in available studies, the effort to draw conclusions about the experiences at different centers is like “comparing apples to oranges.”
“What is the ideal dose and concentrate? We don’t know,” Dr. Keaney said.
The first centrifuge device to receive regulatory approval was developed for orthopedic indications more than 20 years ago. There are now at least 20 centrifuge devices with 510K Food and Drug Administration clearance for separating blood components to produce PRP. The 510K designation means that they are “substantially equivalent” to an already approved device, but Dr. Krueger cautioned that their use in preparing PRP for treatment of hair loss remains off label.
Substandard devices are marketed
In the rapidly expanding world of PRP, there is also a growing array of PRP kits. Some of these kits have been cleared by the FDA but others have not. Dr. Krueger warned that collection tubes are being marketed that are substandard imitations of better-established products. He specifically cautioned against do-it-yourself PRP kits, which are likely to be less effective for isolating platelets and can also be contaminated with pyogenes that cause infection.
“Please use an FDA-cleared kit,” he said, warning that the risk of failing to do so is not just associated with lack of efficacy but also a significant risk of serious adverse events.
Of the centrifuge devices, both Dr. Krueger and Dr. Keaney generally recommend single-spin over double-spin devices, particularly at centers with a limited volume of PRP-based hair loss interventions. These are generally simpler.
Once the PRP has been properly prepared, the efficacy of PRP upon application can also be influenced by strategies for activation. Although the exact mechanism of PRP in stimulating hair growth is incompletely defined, the role of platelets in releasing growth factors is believed to be critical. There are a number of methods to stimulate platelets upon administration, such as exposure to endogenous collagen or thrombin or exogenous chemicals, such as calcium chloride, but again, techniques differ and the optimal approach is unknown.
One concern is the recent and largely unregulated growth of regenerative cell and tissue products for treating a large array of clinical disorders or cosmetic issues, according to Dr. Keaney. He warned of a “wild, wild west mentality” that has attracted providers with inadequate training and experience. In turn, this is now attracting the attention of the FDA as well as those involved in enforcing FDA directives.
“There is definitely more scrutiny of regenerative products,” he said, noting that he is careful about how he markets PRP. While it is reasonable to offer this off-label treatment as an in-office procedure, he noted that it is illegal to advertise off-label products. He reported that he has become more prudent when including this option among hair regrowth services provided in his practice.
Omer E. Ibrahim, MD, a dermatologist affiliated with Chicago Cosmetic Surgery and Dermatology, agreed. While he also feels there is good evidence to support PRP as a hair loss treatment option, particularly for androgenic alopecia, he also expressed caution about promoting this approach in exclusion of other options.
“Patients ask me for a PRP consultation, but there is no such thing as a PRP consultation in my practice,” Dr. Ibrahim said. He incorporates PRP into other strategies. “I stress that it is one part of a multipronged approach,” he added.
Dr. Ibrahim has reported financial relationships with Alastin Skincare, Allergan, Eclipse Medical, Galderma USA, and Revision Skincare. Dr. Keaney has reported financial relationships with Allergan, DermTech, Evolus, Galderma USA, Merz Aesthetics, Revance Therapeutics, and Syneron Candela. Dr. Krueger has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AAD 2022
Mercury and other risks of cosmetic skin lighteners
Skin hyperpigmentation – whether it is caused by postinflammatory hyperpigmentation from acne or trauma to the skin, melasma, autoimmune disorders, or disorders of pigmentation – is a condition where treatment is commonly sought after in dermatology offices. Topical products used to fade hyperpigmented areas of the skin have long been used around the world, and because of safety concerns, regulations aimed at reducing potential harm or adverse effects caused by certain ingredients in these products are increasing in different countries.
For example, while extremely effective at treating most forms of hyperpigmentation, hydroquinone has been definitively linked to ochronosis, kojic acid has been linked to contact dermatitis in humans, and acid peels and retinoids are associated with irritant dermatitis, disruption of the skin barrier, and photosensitivity. In animal studies, licorice root extract has been linked to endocrine and other organ system irregularities.
Kojic acid was banned in Japan in 2003, and subsequently in South Korea and Switzerland because of concerns over animal studies indicating that its fungal metabolite might be carcinogenic (. Hydroquinone is classified as a drug and has been banned for use in cosmetic products in Japan, the European Union, Australia, and several African nations since at least 2006 because of concerns over adrenal gland dysregulation and high levels of mercury in hydroquinone products in those countries. In Africa specifically, South Africa banned all but 2% hydroquinone in 1983, the Ivory Coast banned all skin whitening creams in 2015, and in 2016, Ghana initiated a ban on certain skin products containing hydroquinone.
The United States followed suit in February 2020 with the Food and Drug Administration introducing a ban on all OTC hydroquinone-containing products because of concerns over carcinogenicity in animal studies (which has not been shown in human studies to date). The “Coronavirus Aid, Relief, and Economic Security” (CARES) Act signed in March 2020 then made the changes effective by halting the sale of OTC hydroquinone products in the United States as of September 2020.
Mercury concerns
Despite these bans, hydroquinone continues to be sold in cosmetics and OTC products around the world and online. And despite being banned or limited in these products, in particular. Mercury has been used in cosmetic products as a skin lightening agent (on its own) and as a preservative.
Mercury has been shown to be carcinogenic, neurotoxic, as well as cytotoxic to the renal and endocrine systems, causes reproductive toxicity, and may be bioaccumulative in wildlife and humans. There is particular concern regarding the risks of exposure in pregnant women and babies because of potential harm to the developing brain and nervous system. Initial signs and symptoms of mercury poisoning include irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, numbness and tingling in the hands, feet, or around the mouth.
Organizations such as the Zero Mercury Working Group (ZMWG) – an international coalition of public interest environmental and health nongovernmental organizations from more than 55 countries, focused on eliminating the use, release, and exposure to mercury – have been working to help ensure safety and mercury levels are below the threshold deemed allowable in hydroquinone-containing products.
On March 10, the ZMWG published the results of a new study demonstrating that skin lighteners containing mercury are still being sold online, despite bans and safety concerns. Ebay, Amazon, Shopee, Jiji, and Flipkart are among the websites still selling high mercury–containing skin lightener products. Some of them were the same offenders selling the banned products in 2019. Of the 271 online products tested from 17 countries, nearly half contained over 1 ppm of mercury, which is the legal limit that has been established by most governments and the Minamata Convention on Mercury. Based on their packaging, the majority of these products were manufactured in Asia, most often in Pakistan (43%), Thailand (8%), China (6%), and Taiwan (4%), according to the report.
In ZMWG’s prior publications, mercury concentrations reported in some of these products ranged from 93 ppm to over 16,000 ppm. Even higher concentrations have been reported by other entities. And according to a World Health Organization November 2019 report, mercury-containing skin lightening products have been manufactured in many countries and areas, including Bangladesh, China, Dominican Republic Hong Kong SAR (China), Jamaica, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Republic of Korea, Thailand, and the United States. According to the ZMWG, 137 countries have committed to the Minamata Convention to phase out and limit mercury, including in cosmetics.
Despite bans on some of these products, consumers in the United States and other countries with bans and restrictions are still at risk of exposure to mercury-containing skin lighteners because of online sales. Hopefully, the work of the ZMWG and similar entities will continue to help limit potentially harmful exposures to mercury, while maintaining access to safe and effective methods to treat hyperpigmentation.
Dr. Wesley and Dr. Lily 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.
Skin hyperpigmentation – whether it is caused by postinflammatory hyperpigmentation from acne or trauma to the skin, melasma, autoimmune disorders, or disorders of pigmentation – is a condition where treatment is commonly sought after in dermatology offices. Topical products used to fade hyperpigmented areas of the skin have long been used around the world, and because of safety concerns, regulations aimed at reducing potential harm or adverse effects caused by certain ingredients in these products are increasing in different countries.
For example, while extremely effective at treating most forms of hyperpigmentation, hydroquinone has been definitively linked to ochronosis, kojic acid has been linked to contact dermatitis in humans, and acid peels and retinoids are associated with irritant dermatitis, disruption of the skin barrier, and photosensitivity. In animal studies, licorice root extract has been linked to endocrine and other organ system irregularities.
Kojic acid was banned in Japan in 2003, and subsequently in South Korea and Switzerland because of concerns over animal studies indicating that its fungal metabolite might be carcinogenic (. Hydroquinone is classified as a drug and has been banned for use in cosmetic products in Japan, the European Union, Australia, and several African nations since at least 2006 because of concerns over adrenal gland dysregulation and high levels of mercury in hydroquinone products in those countries. In Africa specifically, South Africa banned all but 2% hydroquinone in 1983, the Ivory Coast banned all skin whitening creams in 2015, and in 2016, Ghana initiated a ban on certain skin products containing hydroquinone.
The United States followed suit in February 2020 with the Food and Drug Administration introducing a ban on all OTC hydroquinone-containing products because of concerns over carcinogenicity in animal studies (which has not been shown in human studies to date). The “Coronavirus Aid, Relief, and Economic Security” (CARES) Act signed in March 2020 then made the changes effective by halting the sale of OTC hydroquinone products in the United States as of September 2020.
Mercury concerns
Despite these bans, hydroquinone continues to be sold in cosmetics and OTC products around the world and online. And despite being banned or limited in these products, in particular. Mercury has been used in cosmetic products as a skin lightening agent (on its own) and as a preservative.
Mercury has been shown to be carcinogenic, neurotoxic, as well as cytotoxic to the renal and endocrine systems, causes reproductive toxicity, and may be bioaccumulative in wildlife and humans. There is particular concern regarding the risks of exposure in pregnant women and babies because of potential harm to the developing brain and nervous system. Initial signs and symptoms of mercury poisoning include irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, numbness and tingling in the hands, feet, or around the mouth.
Organizations such as the Zero Mercury Working Group (ZMWG) – an international coalition of public interest environmental and health nongovernmental organizations from more than 55 countries, focused on eliminating the use, release, and exposure to mercury – have been working to help ensure safety and mercury levels are below the threshold deemed allowable in hydroquinone-containing products.
On March 10, the ZMWG published the results of a new study demonstrating that skin lighteners containing mercury are still being sold online, despite bans and safety concerns. Ebay, Amazon, Shopee, Jiji, and Flipkart are among the websites still selling high mercury–containing skin lightener products. Some of them were the same offenders selling the banned products in 2019. Of the 271 online products tested from 17 countries, nearly half contained over 1 ppm of mercury, which is the legal limit that has been established by most governments and the Minamata Convention on Mercury. Based on their packaging, the majority of these products were manufactured in Asia, most often in Pakistan (43%), Thailand (8%), China (6%), and Taiwan (4%), according to the report.
In ZMWG’s prior publications, mercury concentrations reported in some of these products ranged from 93 ppm to over 16,000 ppm. Even higher concentrations have been reported by other entities. And according to a World Health Organization November 2019 report, mercury-containing skin lightening products have been manufactured in many countries and areas, including Bangladesh, China, Dominican Republic Hong Kong SAR (China), Jamaica, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Republic of Korea, Thailand, and the United States. According to the ZMWG, 137 countries have committed to the Minamata Convention to phase out and limit mercury, including in cosmetics.
Despite bans on some of these products, consumers in the United States and other countries with bans and restrictions are still at risk of exposure to mercury-containing skin lighteners because of online sales. Hopefully, the work of the ZMWG and similar entities will continue to help limit potentially harmful exposures to mercury, while maintaining access to safe and effective methods to treat hyperpigmentation.
Dr. Wesley and Dr. Lily 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.
Skin hyperpigmentation – whether it is caused by postinflammatory hyperpigmentation from acne or trauma to the skin, melasma, autoimmune disorders, or disorders of pigmentation – is a condition where treatment is commonly sought after in dermatology offices. Topical products used to fade hyperpigmented areas of the skin have long been used around the world, and because of safety concerns, regulations aimed at reducing potential harm or adverse effects caused by certain ingredients in these products are increasing in different countries.
For example, while extremely effective at treating most forms of hyperpigmentation, hydroquinone has been definitively linked to ochronosis, kojic acid has been linked to contact dermatitis in humans, and acid peels and retinoids are associated with irritant dermatitis, disruption of the skin barrier, and photosensitivity. In animal studies, licorice root extract has been linked to endocrine and other organ system irregularities.
Kojic acid was banned in Japan in 2003, and subsequently in South Korea and Switzerland because of concerns over animal studies indicating that its fungal metabolite might be carcinogenic (. Hydroquinone is classified as a drug and has been banned for use in cosmetic products in Japan, the European Union, Australia, and several African nations since at least 2006 because of concerns over adrenal gland dysregulation and high levels of mercury in hydroquinone products in those countries. In Africa specifically, South Africa banned all but 2% hydroquinone in 1983, the Ivory Coast banned all skin whitening creams in 2015, and in 2016, Ghana initiated a ban on certain skin products containing hydroquinone.
The United States followed suit in February 2020 with the Food and Drug Administration introducing a ban on all OTC hydroquinone-containing products because of concerns over carcinogenicity in animal studies (which has not been shown in human studies to date). The “Coronavirus Aid, Relief, and Economic Security” (CARES) Act signed in March 2020 then made the changes effective by halting the sale of OTC hydroquinone products in the United States as of September 2020.
Mercury concerns
Despite these bans, hydroquinone continues to be sold in cosmetics and OTC products around the world and online. And despite being banned or limited in these products, in particular. Mercury has been used in cosmetic products as a skin lightening agent (on its own) and as a preservative.
Mercury has been shown to be carcinogenic, neurotoxic, as well as cytotoxic to the renal and endocrine systems, causes reproductive toxicity, and may be bioaccumulative in wildlife and humans. There is particular concern regarding the risks of exposure in pregnant women and babies because of potential harm to the developing brain and nervous system. Initial signs and symptoms of mercury poisoning include irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, numbness and tingling in the hands, feet, or around the mouth.
Organizations such as the Zero Mercury Working Group (ZMWG) – an international coalition of public interest environmental and health nongovernmental organizations from more than 55 countries, focused on eliminating the use, release, and exposure to mercury – have been working to help ensure safety and mercury levels are below the threshold deemed allowable in hydroquinone-containing products.
On March 10, the ZMWG published the results of a new study demonstrating that skin lighteners containing mercury are still being sold online, despite bans and safety concerns. Ebay, Amazon, Shopee, Jiji, and Flipkart are among the websites still selling high mercury–containing skin lightener products. Some of them were the same offenders selling the banned products in 2019. Of the 271 online products tested from 17 countries, nearly half contained over 1 ppm of mercury, which is the legal limit that has been established by most governments and the Minamata Convention on Mercury. Based on their packaging, the majority of these products were manufactured in Asia, most often in Pakistan (43%), Thailand (8%), China (6%), and Taiwan (4%), according to the report.
In ZMWG’s prior publications, mercury concentrations reported in some of these products ranged from 93 ppm to over 16,000 ppm. Even higher concentrations have been reported by other entities. And according to a World Health Organization November 2019 report, mercury-containing skin lightening products have been manufactured in many countries and areas, including Bangladesh, China, Dominican Republic Hong Kong SAR (China), Jamaica, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Republic of Korea, Thailand, and the United States. According to the ZMWG, 137 countries have committed to the Minamata Convention to phase out and limit mercury, including in cosmetics.
Despite bans on some of these products, consumers in the United States and other countries with bans and restrictions are still at risk of exposure to mercury-containing skin lighteners because of online sales. Hopefully, the work of the ZMWG and similar entities will continue to help limit potentially harmful exposures to mercury, while maintaining access to safe and effective methods to treat hyperpigmentation.
Dr. Wesley and Dr. Lily 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.
The science of clean skin care and the clean beauty movement
. I see numerous social media posts, blogs, and magazine articles about toxic skin care ingredients, while more patients are asking their dermatologists about clean beauty products. So, I decided it was time to dissect the issues and figure out what “clean” really means to me.
The problem is that no one agrees on a clean ingredient standard for beauty products. Many companies, like Target, Walgreens/Boots, Sephora, Neiman Marcus, Whole Foods, and Ulta, have their own varying clean standards. Even Allure magazine has a “Clean Best of Beauty” seal. California has Proposition 65, otherwise known as the Safe Drinking Water and Toxic Enforcement Act of 1986, which contains a list of banned chemicals “known to the state to cause cancer or reproductive toxicity.” In January 2021, Hawai‘i law prohibited the sale of oxybenzone and octinoxate in sunscreens in response to scientific studies showing that these ingredients “are toxic to corals and other marine life.” The Environmental Working Group (EWG) rates the safety of ingredients based on carcinogenicity, developmental and reproductive toxicity, allergenicity, and immunotoxicity. The Cosmetic Ingredient Review (CIR), funded by the Personal Care Products Council, consists of a seven-member steering committee that has at least one dermatologist representing the American Academy of Dermatology and a toxicologist representing the Society of Toxicology. The CIR publishes detailed reviews of ingredients that can be easily found on PubMed and Google Scholar and closely reviews animal and human data and reports on safety and contact dermatitis risk.
Which clean beauty standard is best?
I reviewed most of the various standards, clean seals, laws, and safety reports and found significant discrepancies resulting from misunderstandings of the science, lack of depth in the scientific evaluations, lumping of ingredients into a larger category, or lack of data. The most salient cause of misinformation and confusion seems to be hyperbolic claims by the media and clean beauty advocates who do not understand the basic science.
When I conducted a survey of cosmetic chemists on my LinkedIn account, most of the chemists stated that “ ‘Clean Beauty’ is a marketing term, more than a scientific term.” None of the chemists could give an exact definition of clean beauty. However, I thought I needed a good answer for my patients and for doctors who want to use and recommend “clean skin care brands.”
A dermatologist’s approach to develop a clean beauty standard
Many of the standards combine all of the following into the “clean” designation: nontoxic to the environment (both the production process and the resulting ingredient), nontoxic to marine life and coral, cruelty-free (not tested on animals), hypoallergenic, lacking in known health risks (carcinogenicity, reproductive toxicity), vegan, and gluten free. As a dermatologist, I am a splitter more than a lumper, so I prefer that “clean” be split into categories to make it easier to understand. With that in mind, I will focus on clean beauty ingredients only as they pertain to health: carcinogenicity, endocrine effects, nephrotoxicity, hepatotoxicity, immunotoxicity, etc. This discussion will not consider environmental effects, reproductive toxicity (some ingredients may decrease fertility, which is beyond the scope of this article), ingredient sources, and sustainability, animal testing, or human rights violations during production. Those issues are important, of course, but for clarity and simplicity, we will focus on the health risks of skin care ingredients.
In this month’s column, I will focus on a few ingredients and will continue the discussion in subsequent columns. Please note that commercial standards such as Target standards are based on the product type (e.g., cleansers, sunscreens, or moisturizers). So, when I mention an ingredient not allowed by certain company standards, note that it can vary by product type. My comments pertain mostly to facial moisturizers and facial serums to try and simplify the information. The Good Face Project has a complete list of standards by product type, which I recommend as a resource if you want more detailed information.
Are ethanolamines safe or toxic in cosmetics?
Ethanolamines are common ingredients in surfactants, fragrances, and emulsifying agents and include cocamide diethanolamine (DEA), cocamide monoethanolamine (MEA), and triethanolamine (TEA). Cocamide DEA, lauramide DEA, linoleamide DEA, and oleamide DEA are fatty acid diethanolamides that may contain 4% to 33% diethanolamine.1 A Google search of toxic ingredients in beauty products consistently identifies ethanolamines among such offending product constituents. Table 1 reveals that ethanolamines are excluded from some standards and included in others (N = not allowed or restricted by amount used and Y = allowed with no restrictions). As you can see, the standards don’t correspond to the EWG rating of the ingredients, which ranges from 1 (low hazard) to 10 (high hazard).
Why are ethanolamines sometimes considered safe and sometimes not?
Ethanolamines are reputed to be allergenic, but as we know as dermatologists, that does not mean that everyone will react to them. (In my opinion, allergenicity is a separate issue than the clean issue.) One study showed that TEA in 2.5% petrolatum had a 0.4% positive patch test rate in humans, which was thought to be related more to irritation than allergenicity.2 Cocamide DEA allergy is seen in those with hand dermatitis resulting from hand cleansers but is more commonly seen in metal workers.3 For this reason, these ethanolamines are usually found in rinse-off products to decrease exposure time. But there are many irritating ingredients not banned by Target, Sephora, and Ulta, so why does ethanolamine end up on toxic ingredient lists?
First, there is the issue of oral studies in animals. Oral forms of some ethanolamines have shown mild toxicity in rats, but topical forms have not been demonstrated to cause mutagenicity.1
For this reason, ethanolamines in their native form are considered safe.
The main issue with ethanolamines is that, when they are formulated with ingredients that break down into nitrogen, such as certain preservatives, the combination forms nitrosamines, such as N-nitrosodiethylamine (NDEA), which are carcinogenic.4 The European Commission prohibits DEA in cosmetics based on concerns about formation of these carcinogenic nitrosamines. Some standards limit ethanolamines to rinse-off products.5 The CIR panel concluded that diethanolamine and its 16 salts are safe if they are not used in cosmetic products in which N-nitroso compounds can be formed and that TEA and TEA-related compounds are safe if they are not used in cosmetic products in which N-nitroso compounds can be formed.6,7 The FDA states that there is no reason for consumers to be alarmed based on the use of DEA in cosmetics.8
The safety issues surrounding the use of ethanolamines in a skin care routine illustrate an important point: Every single product in the skin care routine should be compatible with the other products in the regimen. Using ethanolamines in a rinse-off product is one solution, as is ensuring that no other products in the skin care routine contain N-nitroso compounds that can combine with ethanolamines to form nitrosamines.
Are natural products safer?
Natural products are not necessarily any safer than synthetic products. Considering ethanolamines as the example here, note that cocamide DEA is an ethanolamine derived from coconut. It is often found in “green” or “natural” skin care products.9 It can still combine with N-nitroso compounds to form carcinogenic nitrosamines.
What is the bottom line? Are ethanolamines safe in cosmetics?
For now, if a patient asks if ethanolamine is safe in skin care, my answer would be yes, so long as the following is true:
- It is in a rinse-off product.
- The patient is not allergic to it.
- They do not have hand dermatitis.
- Their skin care routine does not include nitrogen-containing compounds like N-nitrosodiethanolamine (NDELA) or NDEA.
Conclusion
This column uses ethanolamines as an example to show the disparity in clean standards in the cosmetic industry. As you can see, there are multiple factors to consider. I will begin including clean information in my cosmeceutical critique columns to address some of these issues.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Cocamide DE. J Am Coll Toxicol. 1986;5(5).
2. Lessmann H et al. Contact Dermatitis. 2009 May;60(5):243-55.
3. Aalto-Korte K et al. 2014 Mar;70(3):169-74.
4. Kraeling ME et al. Food Chem Toxicol. 2004 Oct;42(10):1553-61.
5. Fiume MM et al. Int J Toxicol. 2015 Sep;34(2 Suppl):84S-98S.
6. Fiume MM.. Int J Toxicol. 2017 Sep/Oct;36(5_suppl2):89S-110S.
7. Fiume MM et al. Int J Toxicol. 2013 May-Jun;32(3 Suppl):59S-83S.
8. U.S. Food & Drug Administration. Diethanolamine. https://www.fda.gov/cosmetics/cosmetic-ingredients/diethanolamine. Accessed Feb. 12, 2022.
9. Aryanti N et al. IOP Conference Series: Materials Science and Engineering 2021 Feb 1 (Vol. 1053, No. 1, p. 012066). IOP Publishing.
. I see numerous social media posts, blogs, and magazine articles about toxic skin care ingredients, while more patients are asking their dermatologists about clean beauty products. So, I decided it was time to dissect the issues and figure out what “clean” really means to me.
The problem is that no one agrees on a clean ingredient standard for beauty products. Many companies, like Target, Walgreens/Boots, Sephora, Neiman Marcus, Whole Foods, and Ulta, have their own varying clean standards. Even Allure magazine has a “Clean Best of Beauty” seal. California has Proposition 65, otherwise known as the Safe Drinking Water and Toxic Enforcement Act of 1986, which contains a list of banned chemicals “known to the state to cause cancer or reproductive toxicity.” In January 2021, Hawai‘i law prohibited the sale of oxybenzone and octinoxate in sunscreens in response to scientific studies showing that these ingredients “are toxic to corals and other marine life.” The Environmental Working Group (EWG) rates the safety of ingredients based on carcinogenicity, developmental and reproductive toxicity, allergenicity, and immunotoxicity. The Cosmetic Ingredient Review (CIR), funded by the Personal Care Products Council, consists of a seven-member steering committee that has at least one dermatologist representing the American Academy of Dermatology and a toxicologist representing the Society of Toxicology. The CIR publishes detailed reviews of ingredients that can be easily found on PubMed and Google Scholar and closely reviews animal and human data and reports on safety and contact dermatitis risk.
Which clean beauty standard is best?
I reviewed most of the various standards, clean seals, laws, and safety reports and found significant discrepancies resulting from misunderstandings of the science, lack of depth in the scientific evaluations, lumping of ingredients into a larger category, or lack of data. The most salient cause of misinformation and confusion seems to be hyperbolic claims by the media and clean beauty advocates who do not understand the basic science.
When I conducted a survey of cosmetic chemists on my LinkedIn account, most of the chemists stated that “ ‘Clean Beauty’ is a marketing term, more than a scientific term.” None of the chemists could give an exact definition of clean beauty. However, I thought I needed a good answer for my patients and for doctors who want to use and recommend “clean skin care brands.”
A dermatologist’s approach to develop a clean beauty standard
Many of the standards combine all of the following into the “clean” designation: nontoxic to the environment (both the production process and the resulting ingredient), nontoxic to marine life and coral, cruelty-free (not tested on animals), hypoallergenic, lacking in known health risks (carcinogenicity, reproductive toxicity), vegan, and gluten free. As a dermatologist, I am a splitter more than a lumper, so I prefer that “clean” be split into categories to make it easier to understand. With that in mind, I will focus on clean beauty ingredients only as they pertain to health: carcinogenicity, endocrine effects, nephrotoxicity, hepatotoxicity, immunotoxicity, etc. This discussion will not consider environmental effects, reproductive toxicity (some ingredients may decrease fertility, which is beyond the scope of this article), ingredient sources, and sustainability, animal testing, or human rights violations during production. Those issues are important, of course, but for clarity and simplicity, we will focus on the health risks of skin care ingredients.
In this month’s column, I will focus on a few ingredients and will continue the discussion in subsequent columns. Please note that commercial standards such as Target standards are based on the product type (e.g., cleansers, sunscreens, or moisturizers). So, when I mention an ingredient not allowed by certain company standards, note that it can vary by product type. My comments pertain mostly to facial moisturizers and facial serums to try and simplify the information. The Good Face Project has a complete list of standards by product type, which I recommend as a resource if you want more detailed information.
Are ethanolamines safe or toxic in cosmetics?
Ethanolamines are common ingredients in surfactants, fragrances, and emulsifying agents and include cocamide diethanolamine (DEA), cocamide monoethanolamine (MEA), and triethanolamine (TEA). Cocamide DEA, lauramide DEA, linoleamide DEA, and oleamide DEA are fatty acid diethanolamides that may contain 4% to 33% diethanolamine.1 A Google search of toxic ingredients in beauty products consistently identifies ethanolamines among such offending product constituents. Table 1 reveals that ethanolamines are excluded from some standards and included in others (N = not allowed or restricted by amount used and Y = allowed with no restrictions). As you can see, the standards don’t correspond to the EWG rating of the ingredients, which ranges from 1 (low hazard) to 10 (high hazard).
Why are ethanolamines sometimes considered safe and sometimes not?
Ethanolamines are reputed to be allergenic, but as we know as dermatologists, that does not mean that everyone will react to them. (In my opinion, allergenicity is a separate issue than the clean issue.) One study showed that TEA in 2.5% petrolatum had a 0.4% positive patch test rate in humans, which was thought to be related more to irritation than allergenicity.2 Cocamide DEA allergy is seen in those with hand dermatitis resulting from hand cleansers but is more commonly seen in metal workers.3 For this reason, these ethanolamines are usually found in rinse-off products to decrease exposure time. But there are many irritating ingredients not banned by Target, Sephora, and Ulta, so why does ethanolamine end up on toxic ingredient lists?
First, there is the issue of oral studies in animals. Oral forms of some ethanolamines have shown mild toxicity in rats, but topical forms have not been demonstrated to cause mutagenicity.1
For this reason, ethanolamines in their native form are considered safe.
The main issue with ethanolamines is that, when they are formulated with ingredients that break down into nitrogen, such as certain preservatives, the combination forms nitrosamines, such as N-nitrosodiethylamine (NDEA), which are carcinogenic.4 The European Commission prohibits DEA in cosmetics based on concerns about formation of these carcinogenic nitrosamines. Some standards limit ethanolamines to rinse-off products.5 The CIR panel concluded that diethanolamine and its 16 salts are safe if they are not used in cosmetic products in which N-nitroso compounds can be formed and that TEA and TEA-related compounds are safe if they are not used in cosmetic products in which N-nitroso compounds can be formed.6,7 The FDA states that there is no reason for consumers to be alarmed based on the use of DEA in cosmetics.8
The safety issues surrounding the use of ethanolamines in a skin care routine illustrate an important point: Every single product in the skin care routine should be compatible with the other products in the regimen. Using ethanolamines in a rinse-off product is one solution, as is ensuring that no other products in the skin care routine contain N-nitroso compounds that can combine with ethanolamines to form nitrosamines.
Are natural products safer?
Natural products are not necessarily any safer than synthetic products. Considering ethanolamines as the example here, note that cocamide DEA is an ethanolamine derived from coconut. It is often found in “green” or “natural” skin care products.9 It can still combine with N-nitroso compounds to form carcinogenic nitrosamines.
What is the bottom line? Are ethanolamines safe in cosmetics?
For now, if a patient asks if ethanolamine is safe in skin care, my answer would be yes, so long as the following is true:
- It is in a rinse-off product.
- The patient is not allergic to it.
- They do not have hand dermatitis.
- Their skin care routine does not include nitrogen-containing compounds like N-nitrosodiethanolamine (NDELA) or NDEA.
Conclusion
This column uses ethanolamines as an example to show the disparity in clean standards in the cosmetic industry. As you can see, there are multiple factors to consider. I will begin including clean information in my cosmeceutical critique columns to address some of these issues.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Cocamide DE. J Am Coll Toxicol. 1986;5(5).
2. Lessmann H et al. Contact Dermatitis. 2009 May;60(5):243-55.
3. Aalto-Korte K et al. 2014 Mar;70(3):169-74.
4. Kraeling ME et al. Food Chem Toxicol. 2004 Oct;42(10):1553-61.
5. Fiume MM et al. Int J Toxicol. 2015 Sep;34(2 Suppl):84S-98S.
6. Fiume MM.. Int J Toxicol. 2017 Sep/Oct;36(5_suppl2):89S-110S.
7. Fiume MM et al. Int J Toxicol. 2013 May-Jun;32(3 Suppl):59S-83S.
8. U.S. Food & Drug Administration. Diethanolamine. https://www.fda.gov/cosmetics/cosmetic-ingredients/diethanolamine. Accessed Feb. 12, 2022.
9. Aryanti N et al. IOP Conference Series: Materials Science and Engineering 2021 Feb 1 (Vol. 1053, No. 1, p. 012066). IOP Publishing.
. I see numerous social media posts, blogs, and magazine articles about toxic skin care ingredients, while more patients are asking their dermatologists about clean beauty products. So, I decided it was time to dissect the issues and figure out what “clean” really means to me.
The problem is that no one agrees on a clean ingredient standard for beauty products. Many companies, like Target, Walgreens/Boots, Sephora, Neiman Marcus, Whole Foods, and Ulta, have their own varying clean standards. Even Allure magazine has a “Clean Best of Beauty” seal. California has Proposition 65, otherwise known as the Safe Drinking Water and Toxic Enforcement Act of 1986, which contains a list of banned chemicals “known to the state to cause cancer or reproductive toxicity.” In January 2021, Hawai‘i law prohibited the sale of oxybenzone and octinoxate in sunscreens in response to scientific studies showing that these ingredients “are toxic to corals and other marine life.” The Environmental Working Group (EWG) rates the safety of ingredients based on carcinogenicity, developmental and reproductive toxicity, allergenicity, and immunotoxicity. The Cosmetic Ingredient Review (CIR), funded by the Personal Care Products Council, consists of a seven-member steering committee that has at least one dermatologist representing the American Academy of Dermatology and a toxicologist representing the Society of Toxicology. The CIR publishes detailed reviews of ingredients that can be easily found on PubMed and Google Scholar and closely reviews animal and human data and reports on safety and contact dermatitis risk.
Which clean beauty standard is best?
I reviewed most of the various standards, clean seals, laws, and safety reports and found significant discrepancies resulting from misunderstandings of the science, lack of depth in the scientific evaluations, lumping of ingredients into a larger category, or lack of data. The most salient cause of misinformation and confusion seems to be hyperbolic claims by the media and clean beauty advocates who do not understand the basic science.
When I conducted a survey of cosmetic chemists on my LinkedIn account, most of the chemists stated that “ ‘Clean Beauty’ is a marketing term, more than a scientific term.” None of the chemists could give an exact definition of clean beauty. However, I thought I needed a good answer for my patients and for doctors who want to use and recommend “clean skin care brands.”
A dermatologist’s approach to develop a clean beauty standard
Many of the standards combine all of the following into the “clean” designation: nontoxic to the environment (both the production process and the resulting ingredient), nontoxic to marine life and coral, cruelty-free (not tested on animals), hypoallergenic, lacking in known health risks (carcinogenicity, reproductive toxicity), vegan, and gluten free. As a dermatologist, I am a splitter more than a lumper, so I prefer that “clean” be split into categories to make it easier to understand. With that in mind, I will focus on clean beauty ingredients only as they pertain to health: carcinogenicity, endocrine effects, nephrotoxicity, hepatotoxicity, immunotoxicity, etc. This discussion will not consider environmental effects, reproductive toxicity (some ingredients may decrease fertility, which is beyond the scope of this article), ingredient sources, and sustainability, animal testing, or human rights violations during production. Those issues are important, of course, but for clarity and simplicity, we will focus on the health risks of skin care ingredients.
In this month’s column, I will focus on a few ingredients and will continue the discussion in subsequent columns. Please note that commercial standards such as Target standards are based on the product type (e.g., cleansers, sunscreens, or moisturizers). So, when I mention an ingredient not allowed by certain company standards, note that it can vary by product type. My comments pertain mostly to facial moisturizers and facial serums to try and simplify the information. The Good Face Project has a complete list of standards by product type, which I recommend as a resource if you want more detailed information.
Are ethanolamines safe or toxic in cosmetics?
Ethanolamines are common ingredients in surfactants, fragrances, and emulsifying agents and include cocamide diethanolamine (DEA), cocamide monoethanolamine (MEA), and triethanolamine (TEA). Cocamide DEA, lauramide DEA, linoleamide DEA, and oleamide DEA are fatty acid diethanolamides that may contain 4% to 33% diethanolamine.1 A Google search of toxic ingredients in beauty products consistently identifies ethanolamines among such offending product constituents. Table 1 reveals that ethanolamines are excluded from some standards and included in others (N = not allowed or restricted by amount used and Y = allowed with no restrictions). As you can see, the standards don’t correspond to the EWG rating of the ingredients, which ranges from 1 (low hazard) to 10 (high hazard).
Why are ethanolamines sometimes considered safe and sometimes not?
Ethanolamines are reputed to be allergenic, but as we know as dermatologists, that does not mean that everyone will react to them. (In my opinion, allergenicity is a separate issue than the clean issue.) One study showed that TEA in 2.5% petrolatum had a 0.4% positive patch test rate in humans, which was thought to be related more to irritation than allergenicity.2 Cocamide DEA allergy is seen in those with hand dermatitis resulting from hand cleansers but is more commonly seen in metal workers.3 For this reason, these ethanolamines are usually found in rinse-off products to decrease exposure time. But there are many irritating ingredients not banned by Target, Sephora, and Ulta, so why does ethanolamine end up on toxic ingredient lists?
First, there is the issue of oral studies in animals. Oral forms of some ethanolamines have shown mild toxicity in rats, but topical forms have not been demonstrated to cause mutagenicity.1
For this reason, ethanolamines in their native form are considered safe.
The main issue with ethanolamines is that, when they are formulated with ingredients that break down into nitrogen, such as certain preservatives, the combination forms nitrosamines, such as N-nitrosodiethylamine (NDEA), which are carcinogenic.4 The European Commission prohibits DEA in cosmetics based on concerns about formation of these carcinogenic nitrosamines. Some standards limit ethanolamines to rinse-off products.5 The CIR panel concluded that diethanolamine and its 16 salts are safe if they are not used in cosmetic products in which N-nitroso compounds can be formed and that TEA and TEA-related compounds are safe if they are not used in cosmetic products in which N-nitroso compounds can be formed.6,7 The FDA states that there is no reason for consumers to be alarmed based on the use of DEA in cosmetics.8
The safety issues surrounding the use of ethanolamines in a skin care routine illustrate an important point: Every single product in the skin care routine should be compatible with the other products in the regimen. Using ethanolamines in a rinse-off product is one solution, as is ensuring that no other products in the skin care routine contain N-nitroso compounds that can combine with ethanolamines to form nitrosamines.
Are natural products safer?
Natural products are not necessarily any safer than synthetic products. Considering ethanolamines as the example here, note that cocamide DEA is an ethanolamine derived from coconut. It is often found in “green” or “natural” skin care products.9 It can still combine with N-nitroso compounds to form carcinogenic nitrosamines.
What is the bottom line? Are ethanolamines safe in cosmetics?
For now, if a patient asks if ethanolamine is safe in skin care, my answer would be yes, so long as the following is true:
- It is in a rinse-off product.
- The patient is not allergic to it.
- They do not have hand dermatitis.
- Their skin care routine does not include nitrogen-containing compounds like N-nitrosodiethanolamine (NDELA) or NDEA.
Conclusion
This column uses ethanolamines as an example to show the disparity in clean standards in the cosmetic industry. As you can see, there are multiple factors to consider. I will begin including clean information in my cosmeceutical critique columns to address some of these issues.
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Cocamide DE. J Am Coll Toxicol. 1986;5(5).
2. Lessmann H et al. Contact Dermatitis. 2009 May;60(5):243-55.
3. Aalto-Korte K et al. 2014 Mar;70(3):169-74.
4. Kraeling ME et al. Food Chem Toxicol. 2004 Oct;42(10):1553-61.
5. Fiume MM et al. Int J Toxicol. 2015 Sep;34(2 Suppl):84S-98S.
6. Fiume MM.. Int J Toxicol. 2017 Sep/Oct;36(5_suppl2):89S-110S.
7. Fiume MM et al. Int J Toxicol. 2013 May-Jun;32(3 Suppl):59S-83S.
8. U.S. Food & Drug Administration. Diethanolamine. https://www.fda.gov/cosmetics/cosmetic-ingredients/diethanolamine. Accessed Feb. 12, 2022.
9. Aryanti N et al. IOP Conference Series: Materials Science and Engineering 2021 Feb 1 (Vol. 1053, No. 1, p. 012066). IOP Publishing.