An evaluation of the safety and efficacy of fluconazole in the treatment of onychomycosis.

Sixteen subjects were enrolled in this open-label noncomparative study to evaluate the safety and efficacy of fluconazole as a single daily dose for a period of 6 months. Liver function enzymes were monitored to assess safety. An adverse function questionnaire was used on a monthly basis to assess patient tolerance. A visual analogue scale was used to assess efficacy of treatment. After 6 months of fluconazole, all subjects experienced improvement in the appearance of their nails. None of the subjects evidenced any elevation in liver function enzymes. Adverse reactions were limited and consistent with other studies involving fluconazole. Fluconazole proved to be safe and efficacious in the treatment of onychomycosis. Further studies are needed to determine a cost-effective dosing regimen for the treatment of onychomycosis with fluconazole.