Pariser David M, Thiboutot Diane M, Clark Scott D, Jones Terry M, Liu Yin, Graeber Michael
Virginia Clinical Research, Inc, Norfolk, USA.
Cutis. 2005 Aug;76(2):145-51.
A randomized, multicenter, investigator-blinded, active- and vehicle-controlled study was conducted to evaluate the efficacy and safety of adapalene gel 0.3% versus adapalene gel 0.1% and the corresponding gel vehicle. Subjects were assigned randomly to receive either adapalene gel 0.3%, adapalene gel 0.1%, or vehicle once daily for 12 weeks. A total of 214 subjects with moderate to moderately severe acne vulgaris were enrolled, and 85% of subjects completed the study. Adapalene gel 0.3% was significantly superior to adapalene gel 0.1% in total and noninflammatory lesion counts and in global severity score (P < .05 for all). A concentration-dependent increase in clinical benefit for all efficacy assessments was observed. As expected, there were also statistically significant differences in all efficacy parameters in the adapalene gel 0.3% group relative to the vehicle group (P < .001 for all). Treatment-related adverse events were mostly mild-to-moderate and similar between active groups. The results of this study show that adapalene gel 0.3% was superior to adapalene gel 0.1% and vehicle in the treatment of moderate to moderately severe acne while retaining a similar safety and tolerability profile to adapalene 0.1% gel.
进行了一项随机、多中心、研究者设盲、活性药物与赋形剂对照的研究，以评估0.3%阿达帕林凝胶相对于0.1%阿达帕林凝胶及相应凝胶赋形剂的疗效和安全性。受试者被随机分配，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。共纳入214例中度至中度重度寻常痤疮患者，85%的受试者完成了研究。在总皮损计数、非炎性皮损计数及整体严重程度评分方面，0.3%阿达帕林凝胶显著优于0.1%阿达帕林凝胶（所有P值均<0.05）。观察到所有疗效评估的临床获益呈浓度依赖性增加。正如预期的那样，0.3%阿达帕林凝胶组在所有疗效参数方面相对于赋形剂组也存在统计学显著差异（所有P值均<0.001）。治疗相关不良事件大多为轻至中度，且活性药物组之间相似。本研究结果表明，0.3%阿达帕林凝胶在治疗中度至中度重度痤疮方面优于0.1%阿达帕林凝胶和赋形剂，同时保持了与0.1%阿达帕林凝胶相似的安全性和耐受性。
