Randomised double blind comparison of terbinafine and itraconazole for treatment of toenail tinea infection

Abstract

Objective: To compare the efficacy and tolerability of terbinafine and itraconazole in the treatment of toenail tinea unguium. Design: Multicentre, double blind, parallel group study. Setting: 17 university hospitals, one army hospital, and five dermatology practices. Patients: 195 patients with clinically suspected toenail tinea and growth of dermatophytes in baseline culture; data on 86 patients in the terbinafine group and 84 patients in the itraconazole group were fully evaluated for efficacy. Interventions: Daily dose of 250 mg terbinafine or 200 mg itraconazole for 12 weeks, with follow up for a further 40 weeks. Main outcome measures: Mycological cure (negative results on microscopy and culture) and clinical improvement (length and area of unaffected nail) at week 52 or at discontinuation of treatment. Results: At the end of the study mycological cure rates were 81% (70 out of 86) for terbinafine and 63% (53 out of 84) for itraconazole (2PConclusion: Terbinafine is more effective than itraconazole in the treatment of toenail tinea infection.