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, 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%).


CONCLUSIONS
Itraconazole 100 mg once daily is an effective agent for the treatment of tinea cruris and tinea corporis.
Division of Dermatology, Eastern Virginia Medical School, Norfolk, Iowa City.
D M
DM
Pariser
R J
RJ
Pariser
G
G
Ruoff
T L
TL
Ray
D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D013997:Time Factors; D014005:Tinea / Q000188:drug therapy*
D017964:Itraconazole