0.25%盐酸阿莫罗芬霜治疗体股癣和足癣随机单盲对照多中心临床试验

Randomized, investigator-masked, controlled, multicenter clinical trial of 0.25% amorolfine hydrochloride cream in the treatment of tinea corporis and cruris and tinea pedis

目的评价0.25%盐酸阿莫罗芬霜治疗体股癣和足癣的临床疗效及安全性。方法用随机单盲阳性药对照平行分组多中心临床试验,以1%联苯苄唑霜作对照,每天外用0.25%盐酸阿莫罗芬霜1次,疗程体股癣2周,足癣4周;停药后随访2周。结果在停药后2周,0.25%盐酸阿莫罗芬霜治疗体股癣和足癣的综合疗效、临床疗效、真菌学疗效和安全性评价与1%联苯苄唑霜比较均无显著性差异(P>0.05)。结论0.25%盐酸阿莫罗芬霜治疗体股癣和足癣安全、有效。

Objective To assess the clinical efficacy and the safety of (0.25%) amorolfine hydrochloride cream versus that of 1% bifonazole cream in the treatment of tinea corporis and cruris and tinea pedis. Methods This study is a randomized, investigator-masked, active controlled, parallel group, multi-center study, applied once daily 2 weeks for tinea corporis and cruris, 4 weeks for tinea pedis, follow up 2 weeks after end of treatment. Results The assessment of global efficacy, clinical improvement, mycological evaluations, clinical safety as well as laboratory safety tests of assessment 0.25% amorolfine hydrochloride cream are similar to that of 1% bifonazole cream. Conclusion The efficacy and safety of 0.25% amorolfine hydrochloride cream for tinea corporis and cruris and tinea pedis are the same as that of 1% bifonazole cream.