Comparison of 1-week terbinafime hydrochloride cream, 1- and 4-week miconazole nitrate cream in the treatment of interdigital tinea pedis: a multi-center, randomized and double-blind study / 中华皮肤科杂志

ABSTRACT

ObjectiveTo 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. MethodsA 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 (1week 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. ResultsA 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. ConclusionsAs 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.