Kawashima Makoto, Harada Shotaro, Loesche Christian, Miyachi Yoshiki
Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
J Dermatol Sci. 2008 Mar;49(3):241-8. doi: 10.1016/j.jdermsci.2007.09.012. Epub 2007 Dec 11.
Topical retinoids, such as adapalene, are an integral part of acne therapy in most regions and are considered appropriate first-line 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.
To confirm efficacy and safety of adapalene gel 0.1% versus the corresponding gel vehicle in the treatment of Japanese patients with acne vulgaris for up to 12 weeks.
A total of 200 patients were randomized to receive adapalene gel 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.
Adapalene gel 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 gel 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 gel 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.
Adapalene gel 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.
外用维甲酸类药物，如阿达帕林，在大多数地区都是痤疮治疗的重要组成部分，并且除最严重的痤疮病例外，国际指南将其视为所有痤疮病例的合适一线治疗药物。然而，目前在日本尚无用于治疗寻常痤疮的外用维甲酸类药物。
确认0.1%阿达帕林凝胶与相应的凝胶赋形剂相比，在治疗日本寻常痤疮患者长达12周的疗效和安全性。
总共200名患者被随机分配，接受0.1%阿达帕林凝胶或赋形剂，每日一次，持续12周。评估皮损计数（总数、炎性和非炎性）的减少百分比以及受试者满意度。通过不良事件和实验室检查监测安全性。
在终点（第12周，末次观察结转）时，0.1%阿达帕林凝胶在总数（P<0.0001）、炎性（P=0.0010）和非炎性皮损（P<0.0001）方面的减少显著优于凝胶赋形剂，总体受试者满意度更高。在意向性分析人群中，主要疗效变量即终点时总皮损计数减少的中位数百分比，0.1%阿达帕林凝胶（63.2%）显著高于赋形剂（36.9%）（P<0.0001）。早在第1周就观察到显著更好的结果。阿达帕林耐受性良好，不良事件大多为轻至中度且为一过性。
0.1%阿达帕林凝胶对日本寻常痤疮患者有效。阿达帕林安全且耐受性良好，与在其他患者群体中显示的良好耐受性一致。
