Adapalene gel 0.1% is effective and safe for Japanese patients with acne vulgaris: A randomized, multicenter, investigator-blinded, controlled study

Background: Topical retinoids, such as adapalene, are an integral part of acne therapy in most regions and are considered appropriate first-tine therapy by international guidelines for all cases of acne with the exception of the most severe. However, there are currently no topical retinoids available for the treatment of acne vulgaris in Japan. Objective: To confirm efficacy and safety of adapalene get 0.1% versus the corresponding get vehicle in the treatment of Japanese patients with acne vulgaris for up to 12 weeks. Methods: A total of 200 patients were randomized to receive adapalene get 0.1%, or vehicle once-daily for 12 weeks. Percent reduction in lesion counts (total, inflammatory, and non-inflammatory) and subject satisfaction were evaluated. Safety was monitored through adverse events and laboratory tests. Results: Adapalene get 0.1% produced significantly better reductions in total (P < 0.0001), inflammatory (P = 0.0010), and non-inflammatory lesions (P < 0.0001) at endpoint (week 12, last observation carried forward) than get vehicle, with a higher overall subject satisfaction. The primary efficacy variable, the median percent reduction of total lesion counts at endpoint, was significantly greater with adapalene get 0.1% (63.2%) compared to that with the vehicle (36.9%) in the ITT population (P < 0.0001). Significantly greater results were observed as early as week 1. Adapalene was well tolerated, with adverse events that were mostly mild-to-moderate and transient in nature. Conclusions: Adapalene get 0.1% was effective in the treatment of acne vulgaris in Japanese patients. Adapalene was safe and well tolerated, consistent with the good tolerability profile demonstrated in other patient populations. (C) 2007 Japanese Society for Investigative Dermatology. Published by Elsevier Ireland Ltd. All rights reserved.