An open-label, noncomparative, multicenter evaluation of fluconazole with or without urea nail pedicure for treatment of onychomycosis

Fluconazole, a difluorophenyl bis-triazole derivative, has proved effective in the treatment of various systemic mycoses and dermatomycoses. This multicenter study of 114 patients (63 men and 51 women; mean age, 44 years [range, 19 to 70 years]; body weight, 75 kg [range, 52 to 130 kg]) evaluated the efficacy and tolerability of fluconazole for the long-term treatment of onychomycosis. The patients received peroral 150-mg fluconazole once per week and were evaluated monthly during treatment (5 to 12 months; mean, 9.25 months) and 1, 3, and 6 months after discontinuation of therapy. At the last follow-up visit, the clinical response rate was 77%, with a complete clinical cure rate of 54% of all infected nails and 23% improvement rate. The mycologic eradication rate was 76%. Urea treatment was considered for nearly one half of the patients (every other patient entering the study). Clinical cure and relapse rates were not statistically significantly different between groups receiving or not receiving urea treatment. Fluconazole was found in nail samples 1 month after beginning therapy, and was still measurable 6 months after discontinuation of the drug. Only four patients were withdrawn from the study during fluconazole therapy because of mild adverse events. Long-term therapy was well tolerated, with 17 of 114 (15%) patients reporting adverse events of mild-to-moderate severity. The study demonstrated that fluconazole 150 mg once per week was effective and well tolerated in the treatment of onychomycosis.