ONCE-WEEKLY FLUCONAZOLE (450 MG) FOR 4, 6, OR 9 MONTHS OF TREATMENT FOR DISTAL SUBUNGUAL ONYCHOMYCOSIS OF THE TOENAIL

Background: Fluconazole is a bis-triazole antifungal agent approved fo r the treatment of oropharyngeal, esophageal, and vaginal candidiasis, serious systemic candidal infections, and cryptococcal meningitis. Ob jective: The purpose of this study was to evaluate three different dur ations of once-weekly fluconazole for the treatment of onychomycosis o f the toenail caused by dermatophytes. Methods: In a multicenter, rand omized, double-blind, parallel, placebo-controlled trial, 384 patients with distal subungual onychomycosis of the toenail received fluconazo le, 450 mg once weekly, or placebo for 4, 6, or 9 months. For inclusio n, patients were required to have mycologically confirmed distal subun gual onychomycosis of the toenail with a large toenail at least 25% cl inically affected but having at least 2 mm of healthy nail between the nail fold and the proximal onychomycotic border. Efficacy was assesse d by clinical and mycologic (microscopic and microbiologic) measures a t screening, at every treatment visit starting at month 3, and at mont hs 2, 4, and 6 after therapy. Observed or volunteered adverse events w ere recorded and classified at all visits. Results: At the end of trea tment, very significantly superior clinical and mycologic results were achieved in all fluconazole groups compared with placebo (p = 0.0001) . This superiority was largely maintained over 6 months of follow-up. The clinical and mycologic responses of the 9-month treatment duration were significantly superior to the 4- and 6-month durations. Similar percentages of patients in the fluconazole and placebo groups reported adverse experiences for all three durations of the study. Conclusion: Results of this study support the efficacy and safety of fluconazole in the treatment of distal subungual onychomycosis of the toenail.