Double-blind study of the efficacy of 1 week topical terbinafine cream compared to 4 weeks miconazole cream in patients with tinea pedis.

OBJECTIVE: To compare the efficacy of terbinafine cream for 1 week with the efficacy of miconazole cream for 4 weeks in the treatment of tinea pedis. METHOD: Patients who visited our clinic for tinea pedis and who had positive KOH preparation and positive culture for dermatophyte were treated with terbinafine cream for 1 week and placebo for 3 weeks, or with miconazole cream for 4 weeks. Evaluation was done 1, 2, 3, 4 and 10 weeks after the start of the treatment. Mycological cure was defined as presence of a positive KOH preparation and a positive culture before treatment, and negative results for both after treatment. Clinical efficacy was defined as mycological cure and presence of at most a total signs and symptoms score of two. RESULT: Forty-eight patients were studied. Half of them were treated with terbinafine and placebo and the other half with miconazole. Both groups had an equal distribution as to age, sex, race, duration and seriousness of the fungal infection and previous treatment. Mycological cure and clinical efficacy throughout the evaluation were similar in both treatment groups. After 10 weeks, mycological cure was seen in about 52.6 per cent and 55 per cent, and clinical efficacy in about 47 per cent, 45 per cent in terbinafine and miconazole treatment group respectively. CONCLUSION: In the treatment of tinea pedis local application of terbinafine cream for 1 week is as good as treatment with miconazole cream for 4 weeks.