Itraconazole pulse therapy is effective in dermatophyte onychomycosis of the toenail: a double-blind placebo-controlled study

BACKGROUND: Until recently the traditional antifungal agents used to treat onychomycosis of the toenails, griseofulvin and ketoconazole, were generally ineffective and required treatment for a long duration. OBJECTIVE: The objective of the study was to determine the efficacy and safety of itraconazole (pulse) therapy (200 mg twice daily for 1 week a month for three consecutive months) in onychomycosis of the toenails. METHODS: A randomized, multicenter, placebo-controlled Canadian study was conducted in 200 patients. To allow evaluation for efficacy, the KOH and culture had to be positive at baseline. RESULTS: In the itraconazole (n=78) and placebo (n=74) groups, the mycological cure rates were 61.5% and 28.4%, respectively (p