Abstract:

Objective To compare the efficacy and tolerability of 1-week 1% terbinafine hydrochloride cream, 1- and 4-week 2% miconazole nitrate cream in the treatment of interdigital tinea pedis, and to observe the relapse in patients treated with these regimens. Methods A multi-center, randomized, double-blind and parallel group study was conducted. By using a stratified randomization protocol, patients were divided into 3 groups to apply terbinafine cream twice daily for 1 week and inert cream （placebo） for the next 3 weeks （1-week terbinafine group）, miconazole cream twice daily for 1 week and inert cream （placebo） for the next 3 weeks （1-week miconazole group）, and miconazole cream twice daily for 4 weeks （4-week miconazole group）, respectively. Clinical and mycological assessment was made on week 1, 3, 4, 6, 9 and 12 after the initiation of treatment. Results A total of 152 patients with positive baseline mycological culture were eligible for the efficacy analysis. After 4-week treatment, the mycological cure rates were 94.7%, 87.8% and 82.6%, global effective rates 89.5%, 81.6% and 63.0%, respectively for the 1-week terbinafine group, 4-week miconazole group and 1-week miconazole group. On week 12, the mycological relapse rates in 1-week terbinafine, 4-week miconazole and 1-week miconazole group were 13%, 14% and 21% respectively, and the incidence of adverse reaction was 2.38%, 2.38% and 3.57%, respectively. Conclusions As far as the efficacy and recurrence in patients are concerned, the 1-week terbinafine cream regimen is similar to the 4-week miconazole cream regimen for the treatment of interdigital tinea pedis.

Key words: miconazole