[Terbinafine versus miconazole in patients with tinea pedis]

To compare the efficacy of terbinafine cream during 1 week with the efficacy of miconazole cream during 4 weeks in the treatment of tinea pedis.

Prospective randomised double-blind study.

Department of dermatology, Academic Hospital Leiden, the Netherlands.

Patients who visited the general practitioner for tinea pedis and who had a positive KOH preparation were treated with terbinafine cream during 1 week and placebo during 3 weeks, or with miconazole cream during 4 weeks. Evaluation was done 1, 2, 3, 4 and 6 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 a negative result for both after treatment. Clinical efficacy was defined as mycological cure and presence of at most two minor symptoms (erythema, vesicles, squamae, itching) of the previously most serious skin lesion. Evaluation was done of all patients with a positive KOH preparation and of all patients with a positive KOH and a positive culture.

263 patients were included. Of these 207 had a positive culture; 56 patients had a positive KOH preparation but a negative culture. The group of patients treated with terbinafine and placebo consisted of 129 patients, the miconazole group of 134 patients. 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, in both patients with positive KOH preparation and in patients with a positive KOH preparation and a positive culture. After 6 weeks mycological cure was seen in about 95% and clinical efficacy in about 87%.

In the treatment of tinea pedis local application of terbinafine cream during 1 week is as good as treatment with miconazole cream during 4 weeks.