DOUBLE-BLIND COMPARISON OF ITRACONAZOLE AND PLACEBO IN THE TREATMENT OF TINEA-CORPORIS AND TINEA-CRURIS

Background: Tinea corporis and tinea cruris are usually treated with a topical antifungal agent unless the infection is unresponsive, involv es 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 c ruris, or both, over the results obtained with placebo. A second objec tive was to determine the safety of itraconazole, through routine meas urements of serum chemistry profiles. Methods: Sixty-seven patients we re entered into a double-blind, multicenter study to compare the clini cal 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 an d 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 th e itraconazole group had healed or markedly improved lesions, as compa red with 5 of 13 (39%) in the placebo group (p less than or equal to 0 .01). Similarly, the condition in 13 of 23 patients (57%) in the itrac onazole group was mycologically cleared at the end of treatment wherea s this result occurred in only 2 (17%) of 12 patients in the placebo g roup (p =0.02). The prevalence of adverse side effects was lower for t he itraconazole-treated group (20%) than for the placebo-treated group (36%). Conclusion: Itraconazole 100 mg once daily is an effective age nt for the treatment of tinea cruris and tinea corporis.