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Systemic therapy with either oral itraconazole or terbinafine is successful in many patients with toenail onychomycosis, and previous trials have suggested that terbinafine is the most effective. This multicenter, double-blind study conducted in six European countries randomized 506 patients (average age, 50 years) to one of four regimens: terbinafine (250 mg/day) for 12 or 16 weeks, or itraconazole (400 mg/day) for 1 in 4 weeks for 12 or 16 weeks.
All patients had infection confirmed by positive cultures in at least one large toenail and nearly 90% grew Trichophyton rubrum. After 72 weeks, rates of mycologic and complete cure (culture-negative and normal-appearing nails) were significantly higher for terbinafine. Mycologic cure rates were 7…