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
BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.
METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.
CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.
Clinicaltrials.gov registry: (NCT01880320)
J Drugs Dermatol. 2017;16(6):582-589.