0.3%阿达帕林凝胶治疗寻常痤疮：一项多中心、随机、双盲、对照的III期试验。
Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial.
作者信息
Thiboutot Diane, Pariser David M, Egan Nancy, Flores Javier, Herndon James H, Kanof Norman B, Kempers Steven E, Maddin Stuart, Poulin Yves P, Wilson David C, Hwa Joyce, Liu Yin, Graeber Michael
机构信息
Department of Dermatology, Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
出版信息
J Am Acad Dermatol. 2006 Feb;54(2):242-50. doi: 10.1016/j.jaad.2004.10.879.
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.
背景
已研发出一种新的0.3%阿达帕林凝胶制剂。
目的
我们旨在提供证据证明0.3%阿达帕林凝胶在治疗痤疮方面优于0.1%阿达帕林凝胶和凝胶赋形剂。
方法
总共653例患者被随机分为三组，分别每日一次接受0.3%阿达帕林凝胶、0.1%阿达帕林凝胶或赋形剂治疗，为期12周（随机分组比例为2:2:1）。在第8周和第12周时，使用广义估计方程方法对相关重复测量数据进行疗效分析。
结果
0.3%阿达帕林凝胶在成功率、总皮损计数和炎性皮损计数方面显著优于0.1%阿达帕林凝胶和赋形剂。所有疗效指标均显示出一致的剂量依赖性效应。体征和症状大多为轻至中度，且为一过性。
局限性
本试验未研究辅助性外用或口服药物及其对痤疮的影响。
结论
0.3%阿达帕林凝胶治疗痤疮有效且耐受性良好。
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