Terbinafine 1% cream vs. bifonazole 1% cream in the treatment of tinea cruris

A total of 185 patients with a clinical diagnosis of tinea cruris and a pos itive mycologic examination were recruited into this double-blind randomize d multicenter study comparing 1% terbinafine cream once daily for 1 week an d 2 weeks placebo with 1% bifonazole cream applied once daily for 3 weeks. At the first visit and 1, 2, 3, and 8 weeks after the start of the study, s igns and symptoms were assessed clinically and scores were taken for mycolo gic assessments (microscopy and culture). Assessments of clinical signs and symptoms were scored as follows. Pruritus: 0 = absent; 1 = mild, occasiona lly disturbing daily activities; 2 = severe, frequently disturbing daily ac tivities and sleep. Erythema: 0 = absent; 1 = redness; 2 = bright redness, easily visualized. Scales: 0 = absent; 1 = scarcely visible and only in som e areas; 2 = thick, covering a large area. Papule: 0 = absent; 1 = scarcely distributed; 2 = densely distributed and/or in the presence of plaques. At weeks 1, 2, 3, and 8, the effectiveness of therapy was clinically evaluate d globally and given a rating of cured = 0, mild = < 4, or severe = 4-8. Th e primary efficacy parameter was the mycologic cure rate at the follow-up w eeks during treatment and 5 weeks after the end of treatment. The tolerabil ity of the study medication was assessed at weeks 1, 2, and 3 of follow-up. Adverse events were also recorded at the same time. Routine hematologic an d biochemical tests were performed at the start of the study and at the end of treatment.