A comparison of the efficacy of oral fluconazole, 150 mg/week versus 50 mg/day, in the treatment of tinea corporis, tinea cruris, tinea pedis, and cutaneous candidosis.

Abstract

Two hundred and forty five patients with dermatophytoses and cutaneous candidosis were enrolled in the study; 122 were randomized to the once‐weekly regimen and 123 to the once‐daily regimen. Subjects included both men and women; the average age was 42 years. There were no statistically significant differences between the two groups with regard to age, sex, race, and body weight distributions.In the group receiving once‐weekly fluconazole, there were 58 tinea pedis infections and 77 nonpedis infections (tinea corporis, tinea cruris, and cutaneous candidosis). In the group receiving once‐daily fluconazole, there were 56 tinea pedis infections and 76 nonpedis infections. The duration of infection and total score of signs and symptoms did not differ significantly between the two groups.Patients received treatment until clinically cured or up to a maximum of 6 weeks for tinea pedis and 4 weeks for tinea corporis, tinea cruris, or cutaneous candidosis. Medical history, physical and laboratory examinations, and the clinical diagnosis were recorded. Clinical and mycologic examinations and laboratory testing were performed at baseline and 2 weeks after treatment initiation, and then weekly until clinically cured or the maximum duration of treatment allowed was reached. Safety analysis was performed for all patients. Follow‐up clinical and mycologic examinations were performed 1 month after the therapy ended.The clinical efficacy was based on cure (disappearance of all baseline signs and symptoms of infection), marked improvement, moderate improvement, failure (no change or worsening of the signs and symptoms), or unevaluable (most commonly due to protocol evaluations or the absence of an identified pathogen). Mycologic efficacy was based on eradication (absence of pathogen on microscopy and/or culture), persistence (presence of pathogen on microscopy and/or culture), superinfection (absence of pathogen, but with a different fungal pathogen on microscopy and culture associated with clinical disease), or unevaluable. Long‐term follow‐up evaluation included the category relapse, defined as the absence of pathogen at the end of treatment, with the reappearance of that pathogen on microscopy and/or culture at follow‐up visit. The culture result determined the efficacy where discrepancies between microscopy and culture findings occurred.