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0.1%阿达帕林凝胶与0.05%维甲酸乳膏治疗寻常痤疮疗效及安全性的随机对照试验

Randomised, controlled trial of the efficacy and safety of adapalene gel 0.1% and tretinoin cream 0.05% in patients with acne vulgaris.

作者信息

Cunliffe William J, Danby F William, Dunlap Frank, Gold Michael H, Gratton David, Greenspan Alan

机构信息

Departement of Dermatology, General Infirmary, Leeds, UK.

出版信息

Eur J Dermatol. 2002 Jul-Aug;12(4):350-4.

Abstract

BACKGROUND

Previous clinical trials have shown that adapalene gel produces less irritation than tretinoin gels and tretinoin 0.025% cream. Short term results have shown that adapalene is less irritating than tretinoin gels and creams. This study is the first to compare the 0.1% formulation of adapalene gel with the 0.05% strength of tretinoin cream in a formal clinical trial.

OBJECTIVE

To investigate the efficacy and tolerability of adapalene gel 0.1% compared with tretinoin cream 0.05% in patients with mild-to-moderate acne vulgaris.

METHODS

Ten-week, multicentre, randomised, investigator-masked, active-controlled, parallel group study in 409 patients with acne vulgaris.

RESULTS

Adapalene gel 0.1% demonstrated equivalent efficacy in reduction of acne lesion counts and global improvement of acne severity over 10 weeks' treatment and was significantly better tolerated than tretinoin cream 0.05% in terms of erythema, dryness, desquamation and stinging/burning.

CONCLUSION

Adapalene gel 0.1% showed equivalent efficacy and was significantly better tolerated than tretinoin cream 0.05% in patients with mild-to-moderate acne vulgaris.

摘要

背景

先前的临床试验表明,阿达帕林凝胶引起的刺激比维甲酸凝胶和0.025%维甲酸乳膏更少。短期结果显示,阿达帕林比维甲酸凝胶和乳膏的刺激性更小。本研究首次在正式的临床试验中比较0.1%阿达帕林凝胶制剂与0.05%维甲酸乳膏的效果。

目的

研究0.1%阿达帕林凝胶与0.05%维甲酸乳膏治疗轻至中度寻常痤疮患者的疗效和耐受性。

方法

对409例寻常痤疮患者进行为期十周的多中心、随机、研究者设盲、活性药物对照、平行组研究。

结果

在10周的治疗中,0.1%阿达帕林凝胶在减少痤疮皮损数量和整体改善痤疮严重程度方面显示出同等疗效,在红斑、干燥、脱屑和刺痛/灼痛方面,其耐受性明显优于0.05%维甲酸乳膏。

结论

对于轻至中度寻常痤疮患者,0.1%阿达帕林凝胶显示出同等疗效,且耐受性明显优于0.05%维甲酸乳膏。

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