Abstract
Objective: This study was conducted in Japanese patients with acne vulgaris to assess the efficacy of the fixed dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% in comparison with each monad gel as well as the safety and tolerability profile of this fixed dose combination gel in a 12-week treatment.
Methods: This was a multicenter, randomized, double-blinded, active-controlled, parallel group phase 3 study. The study drugs were applied once daily for 12 weeks to the entire face of a total of 417 subjects. The primary efficacy endpoint was the percent reduction in total lesion counts at the last visit. The safety and tolerability profile was assessed with various parameters such as adverse events and skin irritation scores.
Results: A high efficacy of the fixed dose combination gel on total lesion count (median percent reduction: 82.7%) was demonstrated with a statistically significant (p<0.001) superiority over adapalene 0.1% gel (68.6%), but not over benzoyl peroxide 2.5% gel (81.6%). No severe or serious adverse events were reported in this study. Although a higher percentage of subjects experienced signs/symptoms of skin irritation with the fixed dose combination gel as compared to adapalene 0.1% gel and benzoyl peroxide 2.5% gel, the severity of signs/symptoms was mostly mild and moderate in any arms.
Conclusion: This study demonstrated a high efficacy and a good safety/tolerability profile of this fixed dose combination gel in Japanese patients with acne vulgagris, which is consistent with foreign data and supports the good risk/benefit ratio of this product in the treatment of acne vulgaris.Skin Research, 15: 278-293, 2016
