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

J Am Acad Dermatol. 1997 Feb;36(2 Pt 1):231-5. doi: 10.1016/s0190-9622(97)70286-x.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antifungal Agents / administration & dosage*
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Eruptions / etiology
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Hand Dermatoses / drug therapy*
  • Headache / chemically induced
  • Humans
  • Hypertriglyceridemia / chemically induced
  • Itraconazole / administration & dosage*
  • Itraconazole / adverse effects
  • Male
  • Middle Aged
  • Onychomycosis / drug therapy*
  • Pruritus / chemically induced
  • Treatment Outcome


  • Antifungal Agents
  • Itraconazole