Efficacy and tolerability of terbinafine 1% topical solution used for 1 week compared with 4 weeks clotrimazole 1% topical solution in the treatment of interdigital tinea pedis: a randomized, double-blind, multi-centre, 8-week clinical trial

In this double-blind clinical trial 429 patients (217 terbinafine and 212 c lotrimazole) were randomized to receive twice daily terbinafine 1% topical solution for 1 week followed by a vehicle application for 3 weeks, or 1% cl otrimazole solution for 4 weeks. Patients were evaluated clinically and myc ologically at baseline and then at weeks one, two, four (end of treatment), and eight (end of follow-up). To be evaluable the patient needed to have a positive culture for a dermatophyte and positive KOH microscopy and a clin ical diagnosis of tinea pedis (interdigital type) at baseline. Effective tr eatment of tinea pedis was recorded in 181 of 217 (83%) of patients treated for 1 week with terbinafine 1% solution and 174 of 212 (82%) of patients t reated for 4 weeks with clotrimazole 1% solution. Mycological cure and disa ppearance of signs and symptoms were similar at each assessment visit in th e two groups. In the subgroup of patients without any protocol violation th e mycological cure rate was 95% (164 of 173) with terbinafine solution and 91% (159 of 174) with clotrimazole solution (P=0.05). Adverse events believ ed to be drug-related occurred in 13 patients in the terbinafine group and 11 in the clotrimazole group (4 to 5% in each group). The events were prima rily local skin reactions of mild to moderate intensity. It can be conclude d that terbinafine 1% solution used for 1 week to treat tinea pedis is well tolerated and at least as effective as clotrimazole 1% solution used for 4 weeks.