Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender

June 2017 | Volume 16 | Issue 6 | Original Article | 582 | Copyright © June 2017


Linda Stein Gold MD,a William P. Werschler MD,b Jennifer Mohawk PhDc

aDepartment of Dermatology, Henry Ford Hospital, Detroit, MI bDepartment of Medicine/Dermatology, University of Washington, Seattle, WA cGalderma Laboratories, L.P. Fort Worth, TX

effective against both in ammatory and noninflammatory lesions.16 BPO is a potent oxidative antibacterial agent with anti-inflammatory and keratolytic/comedolytic activity that does not promote antibiotic resistance.17,18 Adapalene has comedolytic and anti-inflammatory activity, and has been shown to reduce the formation of microcomedones.4 The fixed combination of A/ BPO is available with two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. A multicenter, randomized, double-blind, vehicle-controlled study assessed the safety and efficacy of A/BPO 0.3%/2.5% gel applied once daily for 12 weeks for the treatment of acne vulgaris. At baseline, 50% of subjects were graded as “moderate” (investigator’s global assessment [IGA] Grade 3) and 50% were graded as “severe” (IGA Grade 4). Subjects ranged in age from 12 to 57 years, and an approximately equal number of males and females were enrolled. Treatment success (defined as the percent of subjects who were rated “clear” or “almost clear" at Week 12, with at least a two grade improvement in IGA) was significantly greater in the A/BPO 0.3%/2.5% group compared to vehicle (33.7% vs 11.0%) in the intent to treat (ITT) population. Mean absolute change from baseline at Week 12 in both in ammatory and noninflammatory lesion counts was also significantly greater for the A/BPO 0.3%/2.5% group than for the vehicle group. The A/BPO 0.3%/2.5% group experienced an average reduction in inflammatory lesions of 27.8 (vs 13.2 for vehicle) and an average reduction in noninflammatory lesions of 40.5 (vs 19.7 for vehicle). Adapalene has been shown to have a concentration-dependent effect, both in vitro and in clinical studies,19 and A/BPO 0.3%/2.5% is stronger than A/BPO 0.1%/2.5%, with improved efficacy shown in moderate to severe acne.16,18 In a population with severe inflammatory acne (n=252), A/BPO 0.3% was shown to be statistically significantly superior to vehicle in achieving success (IGA rating of clear (0) or almost clear (1), indicating at least 3 grades of improvement) vs vehicle (31.9% vs 11.8%, P=0.029). In comparison, success of A/BPO 0.1% was not significantly superior to vehicle (P=0.443), despite similar sample sizes.20 This report details the results of a subanalysis of the well- controlled, randomized pivotal clinical trial16 of topical A/BPO 0.3%/2.5% in two groups of patients with moderate to severe acne: males vs females and 12-17 vs ≥ 18 years.

METHODS

Study Design

Data were analyzed from a multicenter (31 sites, US and Canada), randomized, double-blind, parallel-group, 12-week, controlled study of A/BPO gel 0.3%/2.5% vs vehicle gel in subjects with moderate and severe acne vulgaris. Overall results from the study were published by Stein Gold et al in 2016.16 The objective of this sub-group analysis was to compare the efficacy and safety of A/BPO gel 0.3%/2.5% and vehicle gel in males vs females and in subjects 12-17 years vs ≥ 18 years. A group of subjects treated with A/BPO 0.1%/2.5% was included and served as a benchmark for tolerability – the study was not designed or powered to show superiority between active groups thus results presented here focus on comparison of A/BPO gel 0.3%/2.5% vs vehicle. This study was conducted in accordance with the principles of the Declaration of Helsinki and in compliance with good clinical practices and local regulatory requirements, and was approved by an institutional review board. All subjects provided written informed consent before entering the study.

Subjects

Subjects were aged 12 years or older and had an IGA (5-point scale, 0 - 4) of moderate (IGA 3) to severe (IGA 4). Inclusion criteria were: 20 to 100 in ammatory lesions, 30 to 150 noninflammatory lesions, and no more than 2 acne nodules on the face. Exclusion criteria included acne conglobate, acne fulminans, nodulocystic acne, or acne requiring systemic treatment. Women of childbearing potential were required to agree to use Figure 1