Abstract: Fu Meihua*, Li Min, Li Ruoyu, Wang Aiping, Wen Hai, Guo Zaipei, Hao Fei, Xi Liyan, Yu Hao, She Xiaodong, Chen Wei, Shen Yongnian, Hu Suquan, Liu Weida. *Hospital of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China Corresponding author: Liu Weida, Email: liumyco@hotmail.com 【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, short-term 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 long-term 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