Abstract:

Objective To evaluate the efficacy and safety of luliconazole 1% cream in the treatment of tinea pedis.Methods One hundred and twenty patients positive for fungal elements on direct microscopy were equally and randomly divided into 4 groups:the trial groups applying luliconazole 1% cream for 2 weeks or 4 weeks and the control groups applying naftifine ketoconazole 2 weeks or 4 weeks.Efficacy was assessed in terms of mycological clearance and clinical response rates on week 2,4 and 6 after initiation of treatment.Results In 2-week regimen,the clinical response rates at weeks 2 were 67.86% in trial group and 70.37% in control group (P>0.05);The mycological clearance rates were 46.43% in trial group and 51.85% in control group (P>0.05).They were 85.71% vs.85.19% and 82.14% vs.81.48% respectively at weeks 4 (2 weeks after the end of treatment)(P>0.05).In 4-week regimen,the clinical response rates were 88.89% vs.88.89% and mycological clearance rates were 85.19% vs.88.89% at weeks 4.They were 92.59% vs.88.89% and 88.89% vs.88.89% respectively on 2 weeks after the end of treatment (P>0.05).Treatment-related adverse events consisted of local irritation occurred in 3.33% of patients both in the trial group and control group.Conclusion The efficacy and safety of 1% luliconazole cream in the treatment of tinea pedis are similar to that of naftifine ketoconazole cream.This study suggests that 1% luliconazole cream was effective and safe in the treatment of tinea pedis,with the efficacy of 2-week once-daily regimen equivalent to that of 4-week once-daily regimen.

Key words: luliconazole, naftifine ketoconazole, tinea pedis, clinical efficacy