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