Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes
June 2017 | Volume 16 | Issue 6 | Original Article | 574 | Copyright © June 2017
Andrew F. Alexis MD MPH,a Fran E. Cook-Bolden MD,b and J.P. York PhDc
aSkin of Color Center, Department of Dermatology, Mount Sinai St. Luke’s, New York, NY bSkin Specialty Dermatology, New York, NY cGalderma Laboratories, L.P. Fort Worth, TX
Abstract
BACKGROUND: Acne affects individuals of all races and ethnicities; however, lighter and darker skin phototypes face different treatment challenges that may affect treatment response and tolerability. This analysis investigated possible differences in the efficacy and safety of the fixed dose combination of 0.3% adapalene with 2.5% benzoyl peroxide (A/BPO gel 0.3%/2.5%) in subjects with Fitzpatrick Skin Types (FST) I–VI.
METHODS: This was a post-hoc analysis of a Phase 3, multicenter, randomized, double-blind, parallel-group study of moderate to severe acne in subjects with FST I-VI. Subjects received A/BPO gel 0.3%/2.5%, A/BPO gel 0.1%/2.5% (benchmark), or vehicle, once daily for 12 weeks. Efficacy measurements included success rate (IGA of Clear or Almost Clear), change in inflammatory and noninflammatory lesions from baseline to week 12, safety, and tolerability. The intent to treat (ITT) and safety populations were analyzed. Demographics and disposition were analyzed with descriptive statistics; categorical variables by frequency and percentage; and continuous variables with means, medians, minimum, maximum, and standard deviations.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 128 subjects with FST I-III, and 89 subjects with FST IV-VI. At week 12, A/BPO gel 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle for all FST and severity groups in inflammatory and noninflammatory lesion reduction (P less than equal to .05). Compared to baseline, 32% of subjects with FST I-III were clear or almost clear, compared to 7% in the vehicle group (P=.001). In FST IV–VI, 28% of subjects were clear or almost clear, compared to 15% for vehicle (P=NS). In all treatment groups and skin phototypes, week 12 tolerability scores were similar to baseline scores, and tolerability scores for most subjects of all skin phototypes were “none†or “mild†for all measures.
SUMMARY: We report that the fixed dose combination of A/BPO gel 0.3%/2.5% is efficacious and safe in patients with FST I-VI with moderate and severe inflammatory acne.
Clinicaltrials.gov registry: NCT01880320
J Drugs Dermatol. 2017;16(6):574-581.
INTRODUCTION
Acne vulgaris is a common, chronic, inflammatory disease that occurs most frequently during adolescence. Individuals of any racial or ethnic group or skin type can be affected.1-7 Acne is characterized by the development of noninflammatory (comedones) and inflammatory lesions (papules, pustules, and nodules).8 In individuals of all skin types, slow or improper treatment of inflammatory lesions may lead to scarring.9 The pathophysiology of acne involves inflammatory processes, increased sebum production, abnormal keratinization/desquamation, and the proliferation of Propionibacterium acnes (P. acnes) in the follicles of the skin.8 The treatment of acne in individuals with darker skin phototypes (Fitzpatrick Skin Types [FST] IV to VI) is a topic of increasing importance both in the US and worldwide. People with darker skin phototypes comprise the majority of the world’s population, and individuals within this group represent the fastest-growing segment of the US population.3 Although acne affects individuals with all skin phototypes, subjects with darker skin phototypes are more vulnerable to certain acne related sequelae.4,6-9 Included among these vulnerabilities are an increased risk of postinflammatory hyperpigmentation (PIH) and hypertrophic and keloid scars.4,7,10-13 PIH is a hypermelanotic reaction to cutaneous injury and inflammation that can be induced by acne. The underlying mechanisms of PIH include increased melanin production, transfer of melanin to keratinocytes, and phagocytosis of melanin and melanocytes by macrophages.14-16 It is possible for PIH to spontaneously resolve within weeks, but it is not uncommon for the acne associated hyperpigmentation to persist for multiple months.15-17 Unfortunately, patients have reported that they often find the lingering hyperpigmentation to be just as bothersome as the original acne lesion that induced the PIH.17 It is important to note that the development of PIH may be promoted by the inflammation and irritation associated with overly
