Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial.

Author: Thiboutot D, Pariser DM, Egan N, Flores J, Herndon JH Jr, Kanof NB, Kempers SE, Maddin S, Poulin YP, Wilson DC, Hwa J, Liu Y, Graeber M, Adapalene Study Group

Author affiliation: Department of Dermatology, Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.

Publication date & source: 2006.02, J Am Acad Dermatol., 54(2):242-50.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

BACKGROUND: A new 0.3% gel formulation of adapalene has been developed. OBJECTIVE: We sought to provide evidence of the superiority of adapalene gel 0.3% over adapalene gel 0.1% and gel vehicle in the treatment of acne. METHODS: A total of 653 patients were randomized to receive adapalene gel 0.3%, adapalene gel 0.1%, or vehicle once daily for 12 weeks (2:2:1 randomization). Analysis for efficacy was conducted on correlated repeated measurements at weeks 8 and 12 using Generalized Estimating Equation methodology. RESULTS: Adapalene gel 0.3% was significantly superior to adapalene gel 0.1% and vehicle in success rate, total lesion count, and inflammatory lesion count. A consistent, dose-dependent effect was demonstrated for all efficacy measures. Signs and symptoms were mostly mild to moderate and transient in nature. LIMITATIONS: Adjunctive topical or oral agents and their impact on acne were not studied in this trial. CONCLUSIONS: Adapalene gel 0.3% was effective and well tolerated in the treatment of acne.

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