A multicenter, placebo-controlled, double-blind study of intermittent therapy with itraconazole for the treatment of onychomycosis of the fingernail - 11/09/11
From Dermatology Research, University of California, San Franciscoa; the Department of Dermatology, Columbia Presbyterian Medical Center, New Yorkb; the University of Mississippi Medical Center, Jacksonc; University Hospitals of Clevelandd; the Department of Dermatology, Mt. Sinai Medical Center, Miami Beache; the Division of Dermatology, University of Texas Health Science Center, San Antoniof; and the Janssen Research Foundation, Titusville.g
Abstract |
Background: Onychomycosis is the most frequent cause of nail disease and represents 30% of all mycotic infections of the skin.
Objective: Our purpose was to compare the effectiveness and tolerability of intermittent dosing of itraconazole ("pulse therapy") with placebo in fingernail onychomycosis.
Methods: Seventy-three patients with clinically and mycologically diagnosed fingernailonychomycosis were randomly selected to receive itraconazole, 200 mg twice daily, or placebo for the first week of each month for 2 consecutive months; patients were observed for 19 weeks. Seventy-one patients received the study medication and were included in the safety analysis. Efficacy of treatment was evaluated in 46 patients.
Results: A significantly greater proportion of itraconazole-treated patients than placebo-treated patients achieved clinical success (77% vs 0%), mycologic success (73% vs 13%), and overall success (68% vs 0%). No itraconazole-treated patient had a clinical or mycologic relapse during the follow-up period. Ten itraconazole-treated patients (28%) and nine placebo-treated patients (26%) had adverse events. Three patients discontinued treatment for safety reasons.
Conclusion: Pulse therapy with itraconazole for 2 consecutive months produces significantly greater clinical, mycologic, and overall success than placebo. Short-term itraconazole pulse therapy for fingernail onychomycosis is effective and well tolerated.
(J Am Acad Dermatol 1997;36:231-5.)
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Vol 36 - N° 2
P. 231-235 - febbraio 1997 Ritorno al numero
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