A multicenter, placebo-controlled, double-blind study of intermittent therapy with itraconazole for the treatment of onychomycosis of the fingernail.

Academic Article


  • 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 fingernail onychomycosis 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.
  • Authors


  • Adult, Aged, Antifungal Agents, Double-Blind Method, Drug Administration Schedule, Drug Eruptions, Female, Gastrointestinal Diseases, Hand Dermatoses, Headache, Humans, Hypertriglyceridemia, Itraconazole, Male, Middle Aged, Onychomycosis, Pruritus, Treatment Outcome
  • Author List

  • Odom RB; Aly R; Scher RK; Daniel CR; Elewski BE; Zaias N; DeVillez R; Jacko M; Oleka N; Moskovitz BL
  • Start Page

  • 231
  • End Page

  • 235
  • Volume

  • 36
  • Issue

  • 2 Pt 1