DOUBLE-BLIND, RANDOMIZED COMPARISON OF ITRACONAZOLE CAPSULES VS PLACEBO IN THE TREATMENT OF TOENAIL ONYCHOMYCOSIS

Three multicenter, randomized, double-blind, placebo-controlled studie s were conducted to determine whether twelve weeks of therapy with itr aconazole, 200 mg, was effective in the treatment of dermatophyte infe ction of the toenail. Significantly more patients treated with itracon azole (110 patients) than with placebo (104 patients) achieved clinica l (65 percent vs. 3 percent) and mycologic (54 percent vs. 6 percent) success. The mean percentage of affected reference nail before the ini tiation of therapy was 76 percent, Adverse events were comparable in t he two treatment groups. These findings demonstrate that twelve weeks of continuous itraconazole, 200 mg once daily, is a highly effective, well-tolerated therapy for the management of toenail onychomycosis.