Clinical Evaluation of Glycolic Acid Chemical Peeling in Patients with Acne Vulgaris: A Randomized, Double-Blind, Placebo-Controlled, Split-Face Comparative Study CHIKAKO KAMINAKA, MD, PHD,*† MIKIKO UEDE,* HIROSHI MATSUNAKA,* FUKUMI FURUKAWA, MD, PHD,* AND YUKI YAMOMOTO, MD, PHD*†
BACKGROUND Glycolic acid (GA) peels are frequently performed as adjuvants to the treatment of facial acne. There have been few clinical trials reported of GA peels for acne in people with darker skin. OBJECTIVES Asian skin.
To determine the safety and efficacy of GA peels in the treatment of moderate acne vulgaris in
METHODS In this prospective, randomized, double-blind, placebo-controlled, split-face clinical trial, 26 patients with moderate acne were treated with 40% GA (pH 2.0) on half of the face and placebo on the other half. The procedure was performed five times at 2-week intervals. RESULTS The GA sides had statistically significant reductions in acne lesions at each time point from baseline values. There were statistically significant differences between the GA and placebo sides. The GA sides had better responses for noninflammatory lesions than for inflammatory lesions. In bioengineering measurements, sebum levels were statistically significantly reduced after the initiation of therapy on both sides at weeks 8 and 10, but there were no statistically significant differences between the two sides. CONCLUSION Forty percent GA peels significantly improved moderate acne in this study. It is effective and safe in Asians. The authors have indicated no significant interest with commercial supporters.
A
cne vulgaris is one of the most common skin diseases, affecting all ages, and is commonly treated by physicians.1–3 It is a disorder that arises from several pathophysiologic mechanisms: high sebum production and keratinocyte proliferation of follicle epithelium that results in follicular blockage and the subsequent development of noninflammatory acne lesions (microcomedones, which can mature into open or closed comedones).1 There is also activation of the innate immune response, partly as a consequence of follicular colonization with Propionibacterium acnes, leading to inflammatory acne lesions (papules or pustules).1 These are
the main targets of currently available treatment modalities for acne vulgaris. Pharmacologic therapies such as topical antibiotics, oral antibiotics, topical retinoids, topical benzoyl peroxide, and oral retinoids are the recommended first-line treatment, but they commonly require long-term use and can be associated with significant side effects, including the emergence of resistant strains of P. acnes.1–4 Nonpharmacologic treatments have been increasingly used for acne vulgaris independently or in
*Department of Dermatology, Wakayama Medical University, Wakayama, Japan; †Department of Cosmetic Dermatology and Photomedicine, Wakayama Medical University, Wakayama, Japan Kaminaka and Uede contributed equally to this work. © 2014 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc. ISSN: 1076-0512 Dermatol Surg 2014;40:314–322 DOI: 10.1111/dsu.12417 314
KAMINAKA ET AL
combination with medical therapeutic modalities. Superficial chemical peels are frequently performed as adjuvants to the pharmacologic treatment of facial acne.2 The aim is remove the corneum stratum, enhancing physiologic cell turnover. Various superficial chemical peels have been used as peeling agents, of which the most readily available commercial agent are alpha-hydroxy acids such as glycolic acid (GA).5–11 Glycolic acid peels are effective in treating noninflammatory lesions and inflammatory eruptions. Previous studies have shown that GA peels have antibactericidal effects on P. acnes and antioxidant action. They can also correct the abnormal keratinization seen in acne, promoting epidermolysis, dispersing basal layer melanin and epidermal and dermal hyaluronic acid, and enhancing collagen gene expression that increases through an increase in secretion of interleukin-6.11–13 There have been very few clinical trials of GA peels for acne in darker-skinned people, including Asians. A majority of these trials were not controlled and were open label, with differences in assessments, treatment regimens, and patient populations, and the use of concomitant acne medications was allowed. Therefore, none of these studies evaluated the effect of peeling alone.5,7–9,14–21 The purpose of this study was to examine the evidence base that supports GA peels in the treatment of facial acne in Asians.
Patients Japanese patients aged 20 and older (N = 26) with moderate to severe facial acne vulgaris were enrolled in the study in the Department of Dermatology at Wakayama Medical University. Patients with moderate facial acne vulgaris had 6 to 20 inflammatory lesions and up to 20 noninflammatory lesions on half of their face, and those with severe acne had 21 to 50 inflammatory lesions, based on the Japanese grading criteria for acne severity.
A wash-out period was required of topical and oral antibiotic, retinoid, and corticosteroid agent administration before the start of treatment of at least 2 months. Patients were excluded if they had acne conglobata, acne fulminans, secondary acne, or other dermatologic conditions requiring systemic treatment. Women were excluded if they were pregnant, planning pregnancy, or nursing. Written informed consent was obtained from each patient.
Methods Study Design The efficacy and safety of GA peeling was compared with the same pH acid gel vehicle peeling in a 10week, single-center, double-blind, prospective, randomized, split-face comparative study conducted at Wakayama Medical University in Japan between November 2010 and April 2012. Blinding integrity was ensured by packaging the topical medication in identical bottles, with the same pH acid peel (pH 2.0 hydrochloric acid) so that subjects experienced the same texture and feel. Clinical assessment at baseline included demographic data, previous medical history, and total inflammatory and noninflammatory lesion counts. According to the split-face technique, the treatment sites were randomly assigned before the first treatment visit by assigning one side of the face to receive a GA peel and the other side to receive a placebo peel. Patient participation in this study consisted of five treatments administered every 2 weeks, with a followup visit 2 weeks after the last treatment (10 weeks). Two blinded dermatologists performed all assessments.
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GA PEELING FOR TREATING ACNE
Procedure Treatment sites were randomly assigned before the first treatment visit by assigning one side of the face to receive the 40% GA (pH 2.0) peel and the other side to receive a placebo peel (pH 2.0 hydrochloric acid in polyethylene glycol vehicle 45M). Before application of these agents, the entire face was cleansed with a mild, soapless cleanser and patted dry. The face was then gently degreased with rubbing alcohol on cotton gauze. The peels were applied with soft brush applicators for 3 minutes, and both sides of the face were neutralized with 10% bicarbonate solution at the end of treatment and then rinsed with tap water. After the peel, we recommended the use of moisturizing cream and sunscreen. The same procedures were repeated every 2 weeks for a total of five applications, with the same location treated at each application. The complete treatment protocol was concluded in 8 weeks, with a follow-up visit 2 weeks after the last treatment (10 weeks). Assessment of Efficacy Efficacy and safety assessments were performed at baseline and weeks 2, 4, 6, 8, and 10. Photographs were also taken (VISIA Evolution, Canfield Scientific, Inc., Fairfield, CT). At each visit, the same investigator counted the numbers of inflammatory (papules and pustules), noninflammatory (open and closed comedones), and total acne lesions on each half of the face. The physicians made an overall judgment of therapeutic efficacy at the end of study according to the following scale: excellent (>75% reduction), good (50–75% reduction), fair (25–50% reduction) and poor (
BACKGROUND Glycolic acid (GA) peels are frequently performed as adjuvants to the treatment of facial acne. There have been few clinical trials reported of GA peels for acne in people with darker skin. OBJECTIVES Asian skin.
To determine the safety and efficacy of GA peels in the treatment of moderate acne vulgaris in
METHODS In this prospective, randomized, double-blind, placebo-controlled, split-face clinical trial, 26 patients with moderate acne were treated with 40% GA (pH 2.0) on half of the face and placebo on the other half. The procedure was performed five times at 2-week intervals. RESULTS The GA sides had statistically significant reductions in acne lesions at each time point from baseline values. There were statistically significant differences between the GA and placebo sides. The GA sides had better responses for noninflammatory lesions than for inflammatory lesions. In bioengineering measurements, sebum levels were statistically significantly reduced after the initiation of therapy on both sides at weeks 8 and 10, but there were no statistically significant differences between the two sides. CONCLUSION Forty percent GA peels significantly improved moderate acne in this study. It is effective and safe in Asians. The authors have indicated no significant interest with commercial supporters.
A
cne vulgaris is one of the most common skin diseases, affecting all ages, and is commonly treated by physicians.1–3 It is a disorder that arises from several pathophysiologic mechanisms: high sebum production and keratinocyte proliferation of follicle epithelium that results in follicular blockage and the subsequent development of noninflammatory acne lesions (microcomedones, which can mature into open or closed comedones).1 There is also activation of the innate immune response, partly as a consequence of follicular colonization with Propionibacterium acnes, leading to inflammatory acne lesions (papules or pustules).1 These are
the main targets of currently available treatment modalities for acne vulgaris. Pharmacologic therapies such as topical antibiotics, oral antibiotics, topical retinoids, topical benzoyl peroxide, and oral retinoids are the recommended first-line treatment, but they commonly require long-term use and can be associated with significant side effects, including the emergence of resistant strains of P. acnes.1–4 Nonpharmacologic treatments have been increasingly used for acne vulgaris independently or in
*Department of Dermatology, Wakayama Medical University, Wakayama, Japan; †Department of Cosmetic Dermatology and Photomedicine, Wakayama Medical University, Wakayama, Japan Kaminaka and Uede contributed equally to this work. © 2014 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc. ISSN: 1076-0512 Dermatol Surg 2014;40:314–322 DOI: 10.1111/dsu.12417 314
KAMINAKA ET AL
combination with medical therapeutic modalities. Superficial chemical peels are frequently performed as adjuvants to the pharmacologic treatment of facial acne.2 The aim is remove the corneum stratum, enhancing physiologic cell turnover. Various superficial chemical peels have been used as peeling agents, of which the most readily available commercial agent are alpha-hydroxy acids such as glycolic acid (GA).5–11 Glycolic acid peels are effective in treating noninflammatory lesions and inflammatory eruptions. Previous studies have shown that GA peels have antibactericidal effects on P. acnes and antioxidant action. They can also correct the abnormal keratinization seen in acne, promoting epidermolysis, dispersing basal layer melanin and epidermal and dermal hyaluronic acid, and enhancing collagen gene expression that increases through an increase in secretion of interleukin-6.11–13 There have been very few clinical trials of GA peels for acne in darker-skinned people, including Asians. A majority of these trials were not controlled and were open label, with differences in assessments, treatment regimens, and patient populations, and the use of concomitant acne medications was allowed. Therefore, none of these studies evaluated the effect of peeling alone.5,7–9,14–21 The purpose of this study was to examine the evidence base that supports GA peels in the treatment of facial acne in Asians.
Patients Japanese patients aged 20 and older (N = 26) with moderate to severe facial acne vulgaris were enrolled in the study in the Department of Dermatology at Wakayama Medical University. Patients with moderate facial acne vulgaris had 6 to 20 inflammatory lesions and up to 20 noninflammatory lesions on half of their face, and those with severe acne had 21 to 50 inflammatory lesions, based on the Japanese grading criteria for acne severity.
A wash-out period was required of topical and oral antibiotic, retinoid, and corticosteroid agent administration before the start of treatment of at least 2 months. Patients were excluded if they had acne conglobata, acne fulminans, secondary acne, or other dermatologic conditions requiring systemic treatment. Women were excluded if they were pregnant, planning pregnancy, or nursing. Written informed consent was obtained from each patient.
Methods Study Design The efficacy and safety of GA peeling was compared with the same pH acid gel vehicle peeling in a 10week, single-center, double-blind, prospective, randomized, split-face comparative study conducted at Wakayama Medical University in Japan between November 2010 and April 2012. Blinding integrity was ensured by packaging the topical medication in identical bottles, with the same pH acid peel (pH 2.0 hydrochloric acid) so that subjects experienced the same texture and feel. Clinical assessment at baseline included demographic data, previous medical history, and total inflammatory and noninflammatory lesion counts. According to the split-face technique, the treatment sites were randomly assigned before the first treatment visit by assigning one side of the face to receive a GA peel and the other side to receive a placebo peel. Patient participation in this study consisted of five treatments administered every 2 weeks, with a followup visit 2 weeks after the last treatment (10 weeks). Two blinded dermatologists performed all assessments.
40:3:MARCH 2014
315
GA PEELING FOR TREATING ACNE
Procedure Treatment sites were randomly assigned before the first treatment visit by assigning one side of the face to receive the 40% GA (pH 2.0) peel and the other side to receive a placebo peel (pH 2.0 hydrochloric acid in polyethylene glycol vehicle 45M). Before application of these agents, the entire face was cleansed with a mild, soapless cleanser and patted dry. The face was then gently degreased with rubbing alcohol on cotton gauze. The peels were applied with soft brush applicators for 3 minutes, and both sides of the face were neutralized with 10% bicarbonate solution at the end of treatment and then rinsed with tap water. After the peel, we recommended the use of moisturizing cream and sunscreen. The same procedures were repeated every 2 weeks for a total of five applications, with the same location treated at each application. The complete treatment protocol was concluded in 8 weeks, with a follow-up visit 2 weeks after the last treatment (10 weeks). Assessment of Efficacy Efficacy and safety assessments were performed at baseline and weeks 2, 4, 6, 8, and 10. Photographs were also taken (VISIA Evolution, Canfield Scientific, Inc., Fairfield, CT). At each visit, the same investigator counted the numbers of inflammatory (papules and pustules), noninflammatory (open and closed comedones), and total acne lesions on each half of the face. The physicians made an overall judgment of therapeutic efficacy at the end of study according to the following scale: excellent (>75% reduction), good (50–75% reduction), fair (25–50% reduction) and poor (
