市售六种维A酸外用制剂对皮肤累积刺激性的评估

目的 评价常用维A酸外用制剂对皮肤的累积刺激作用.方法 采用随机对照、双盲法将试验药与对照药分为7组.对受试者每周每种药品进行4次24h的斑贴试验和1次72h的斑贴试验观察.共进行3周的观察.结果 累积刺激最小的是0.1%阿达帕林凝胶组,累积刺激指数为0.09±0.11,其20d的累积刺激指数为0.09±0.11;累积刺激作用最大的0.1%维A酸霜组为0.59±0.24,2组比较差异有显著性(P<0.001).0.1%阿达帕林凝胶的累积刺激指数还明显小于0.025%维A酸霜组(0.41±0.22)和0.05%维A酸霜组(0.25±0.22).结论 国内外常用的治疗痤疮的维A酸外用制剂是安全的.外用阿达帕林凝胶的刺激作用不但明显小于0.1%维A酸霜,也小于0.05%维A酸霜.

Evaluation of Cumulative Skin-irritation of Six Commercinlly Available Topical Retinoic Acid Preparations

Objective To evaluate the cumulative irritative effect of topical retinoic acid preparations on normal skin.Methods A randomlized,doubled blind,placebo-controlled clinical trial was carried out with7groups for 6 tested preparations.All subjects were patch tested with each preparation for 24 hours on Monday to Thursday,and for 72 hours on Friday.The patch tests were performed for 3 consecutive weeks.Results The minimal cumulative irritative effects were found in Group G treated with 0.1% adapalene gel,with a cumulative irritative index of 0.09±0.11 in 20 days.The cumulative irritative index was significantly lower in Group G than that in Group B treated with 0.1% retinoic acid(Diweishuang^®)(0.59±0.24),or in 0.025% retinoic acid(Diweishuang^®)(0.41±0.22),or in 0.05% retinoic acid(VITAMIN^® Cream)(0.25±0.22).Conclusion Adapalene,the third generation of retinoic acid,is characterized by lower irritative effects in comparison to the first generation of topical retinoic acid agents.