Double-blind comparison of itraconazole and placebo in the treatment of tinea corporis and tinea cruris

J Am Acad Dermatol. 1994 Aug;31(2 Pt 1):232-4. doi: 10.1016/s0190-9622(94)70153-9.

Abstract

Background: Tinea corporis and tinea cruris are usually treated with a topical antifungal agent unless the infection is unresponsive, involves an extensive area, is chronic, or is in a difficult-to-access area. In these cases oral antifungals are frequently used.

Objective: This double-blind study was undertaken to determine whether a 2-week course of oral itraconazole would produce statistically significant clinical and mycologic improvement in the treatment of tinea corporis, tinea cruris, or both, over the results obtained with placebo. A second objective was to determine the safety of itraconazole, through routine measurements of serum chemistry profiles.

Methods: Sixty-seven patients were entered into a double-blind, multicenter study to compare the clinical and mycologic effects of itraconazole, 100 mg daily (45 patients), and placebo (22 patients) on tinea corporis and/or tinea cruris. The duration of treatment was 2 weeks. The investigators assessed signs and symptoms and performed a potassium hydroxide examination and culture at baseline, at termination of therapy, and 2 weeks after completion of treatment.

Results: Twenty-two (96%) of 23 evaluable patients in the itraconazole group had healed or markedly improved lesions, as compared with 5 of 13 (39%) in the placebo group (p < or = 0.01). Similarly, the condition in 13 of 23 patients (57%) in the itraconazole group was mycologically cleared at the end of treatment whereas this result occurred in only 2 (17%) of 12 patients in the placebo group (p = 0.02). The prevalence of adverse side effects was lower for the itraconazole-treated group (20%) than for the placebo-treated group (36%).

Conclusion: Itraconazole 100 mg once daily is an effective agent for the treatment of tinea cruris and tinea corporis.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Headache / chemically induced
  • Humans
  • Itraconazole / administration & dosage
  • Itraconazole / adverse effects
  • Itraconazole / therapeutic use*
  • Male
  • Time Factors
  • Tinea / drug therapy*

Substances

  • Itraconazole