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

BackgroundA new 0.3% gel formulation of adapalene has been developed.ObjectiveWe 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.MethodsA 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.ResultsAdapalene 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.LimitationsAdjunctive topical or oral agents and their impact on acne were not studied in this trial.ConclusionsAdapalene gel 0.3% was effective and well tolerated in the treatment of acne.