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Terbinafine vs. placebo for onychomycosis in black patients

Eight US centers enrolled in a multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group trial comparing the efficacy of 12, 16, and 24 weeks of oral therapy with terbinafine, 250 mg/day, and placebo in patients aged 18 to 75 years with both a positive KOH wet mount and mycologic culture of one or more dermatophytes from the large toenail, designated as the target toenail, or another infected toenail if no large toenail was infected. Primary exclusion criteria included: systemic antifungal therapy during the previous 3 months; topical antifungal therapy for the infected toenail(s) during the previous month; white superficial toenail onychomycosis; immunosuppression or immunodeficiency, including known human immunodeficiency virus (HIV) infection; hepatic enzymes >1.5 times the upper limit of normal at screening; and any marked laboratory abnormalities.