Loesche Christian, Pernin Colette, Poncet Michel
Galderma Research & Development, 2400 route des Colles, 06410 Biot, France.
Eur J Dermatol. 2008 Sep-Oct;18(5):524-6. doi: 10.1684/ejd.2008.0488. Epub 2008 Aug 8.
International guidelines recommend the combination of retinoids (e.g. adapalene, tazarotene) and benzoyl peroxide for treating acne because of their complementary mechanisms of action. A new fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide (BPO) 2.5% (adapalene/BPO*) is an effective acne treatment and offers the advantage of a once daily application. This paper reports the results of a cumulative irritancy study in healthy volunteers comparing adapalene/BPO to adapalene 0.1% and BPO 2.5% applied separately, BPO 10% gel, tazarotene 0.1% gel and the gel vehicle as a control.There was no significant difference between the mean cumulative irritation index (MCII) for adapalene/BPO and any test product except tazarotene 0.1% gel, which had a significantly greater MCII than all other test products (p < 0.05). This study showed that adapalene/BPO as a fixed-dose combination is as well tolerated as BPO 2.5% gel alone or adapalene 0.1% gel alone in terms of cumulative irritancy.*Epiduo, Galderma S.A.
国际指南推荐使用维甲酸类药物（如阿达帕林、他扎罗汀）和过氧化苯甲酰联合治疗痤疮，因为它们的作用机制具有互补性。一种新的固定剂量复方凝胶，即0.1%阿达帕林和2.5%过氧化苯甲酰（BPO）（阿达帕林/ BPO*），是一种有效的痤疮治疗药物，具有每日只需用药一次的优点。本文报告了一项针对健康志愿者的累积刺激性研究结果，该研究将阿达帕林/ BPO与单独使用的0.1%阿达帕林、2.5%BPO、10%BPO凝胶、0.1%他扎罗汀凝胶以及作为对照的凝胶基质进行了比较。阿达帕林/ BPO的平均累积刺激指数（MCII）与除0.1%他扎罗汀凝胶之外的任何测试产品之间均无显著差异，0.1%他扎罗汀凝胶的MCII显著高于所有其他测试产品（p < 0.05）。该研究表明，就累积刺激性而言，固定剂量复方的阿达帕林/ BPO与单独使用2.5%BPO凝胶或0.1%阿达帕林凝胶的耐受性相当。
