A double-blind, randomized study to compare the efficacy and safety of terbinafine (Lamisil (R)) with fluconazole (Diflucan (R)) in the treatment of onychomycosis

In a randomized, double-blind, double-placebo, multicentre study, terbinafi ne 250 mg daily for 12 weeks was compared with fluconazole 150 mg once week ly for 12 or 24 weeks in the treatment of onychomycosis. A total of 137 pat ients with culture-confirmed onychomycosis was divided into three groups: g roup A received terbinafine for 12 weeks, group B received fluconazole for 12 weeks, while group C received fluconazole for 24 weeks. At completion of the study (week 60), the mycological cure rate was higher in the terbinafi ne group than in the fluconazole groups: 89% vs. 51% and 49%, respectively (P < 0.001). The length of unaffected nail increased until week 24 in group B and until week 36 in group C, but was still increasing in group A at the final visit (week 60), Complete clinical cure of the target nail at week 6 0 was 67% in the terbinafine group, compared with 21% and 32% in the flucon azole groups, respectively. The incidence of adverse events was low for bot h study agents. We conclude that terbinafine 250 mg daily for 12 weeks is s ignificantly more effective in the treatment of onychomycosis than fluconaz ole 150 mg once weekly for either 12 or 24 weeks.