A MULTICENTER, PLACEBO-CONTROLLED, DOUBLE-BLIND-STUDY OF INTERMITTENTTHERAPY WITH ITRACONAZOLE FOR THE TREATMENT OF ONYCHOMYCOSIS OF THE FINGERNAIL

Background: Onychomycosis is the most frequent cause of nail disease a nd represents 30% of all mycotic infections of the skin. Objective: Ou r purpose was to compare the effectiveness and tolerability of intermi ttent dosing of itraconazole (''pulse therapy'') with placebo in finge rnail onychomycosis. Methods: Seventy-three patients with clinically a nd mycologically diagnosed fingernail onychomycosis were randomly sele cted to receive itraconazole, 200 mg twice daily, or placebo for the f irst week of each month for 2 consecutive months; patients were observ ed for 19 weeks. Seventy-one patients received the study medication an d were included in the safety analysis. Efficacy of treatment was eval uated in 46 patients. Results: A significantly greater proportion of i traconazole-treated patients than placebo-treated patients achieved cl inical success (77% vs 0%), mycologic success (73% vs 13%), and overal l success (68% vs 0%). No itraconazole-treated patient had a clinical or mycologic relapse during the follow-up period. Ten itraconazole-tre ated patients (28%) and nine placebo-treated patients (26%) had advers e events. Three patients discontinued treatment for safety reasons. Co nclusion: Pulse therapy with itraconazole for 2 consecutive months pro duces significantly greater clinical, mycologic, and overall success t han placebo. Short-term itraconazole pulse therapy for fingernail onyc homycosis is effective and well tolerated.