Comparison of 2 weeks versus 4 weeks of luliconazole 1％ cream for the treatment of tinea pedis: a randomized, double-blind, multicenter, controlled trial

Abstract

Objective To evaluate the efficacy and safety of different courses of luliconazole 1％ cream in the treatment of tinea pedis.Methods A randomized,double-blind,multicenter controlled trial was conducted.According to a stratified randomization protocol,420 patients positive for fungal elements on direct microscopy were equally and randomly divided into 3 groups:short-term group applying luliconazole 1％ cream once daily for 2 weeks followed by placebo once daily for the next 2 weeks,long-term group applying luliconazole 1％ cream once daily for 4 weeks,bifonazole group applying bifonazole 1％ cream once daily for 4 weeks.Efficacy was assessed in terms of mycological clearance and clinical response rates on week 2,3,4 and 6 after initiation of treatment.Statistical analysis was carried out by paired t test,analysis of variance,chi-square test and a nonparametric test.Results Finally,398 patients were eligible for the efficacy analysis.The clinical response rate in the bifonazole group,shortterm group and long-term group was 29.29％,31.43％ and 35.00％ respectively on week 2 after initiation of treatment (P ＞ 0.05),73.57％,78.57％ and 70.00％ respectively on week 3 (P ＞ 0.05),89.29％,91.43％ and 89.29％ respectively on week 4 (P ＞ 0.05),with the mycological clearance rate being 49.29％,58.57％ and 57.86％ respectively on week 2 (P ＞ 0.05),80.00％,87.86％ and 85.00％ respectively on week 4 (P ＞ 0.05).Significant differences were observed on week 2 after the end of treatment in mycological clearance rate (80.71％ in the bifonazole group vs.90.00％ in the short-term group vs.89.29％ in the long-term group,P ＜ 0.05),but not in clinical response rate (92.14％ in the bifonazole group vs.92.86％ in the short-term group vs.92.14％ in the longterm group,P ＞ 0.05).The incidence rate of local adverse reactions was 0.71％ in the bifonazole group,0 in the short-term group and 2.14％ in the long-term group.Conclusion Luliconazole 1％ cream is effective and well tolerated 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; Bifonazole; Tinea, pedis; Clinical protocols; Randomized controlled trials