A total of 185 patients with a clinical diagnosis of tinea cruris and a positive mycologic examination were recruited into this double-blind randomized multicenter study comparing 1% terbinafine cream once daily for 1 week and 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, signs and symptoms were assessed clinically and scores were taken for mycologic assessments (microscopy and culture). Assessments of clinical signs and symptoms were scored as follows. Pruritus: 0 = absent; 1 = mild, occasionally disturbing daily activities; 2 = severe, frequently disturbing daily activities and sleep. Erythema: 0 = absent; 1 = redness; 2 = bright redness, easily visualized. Scales: 0 = absent; 1 = scarcely visible and only in some 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 evaluated globally and given a rating of cured = 0, mild = <4, or severe = 4-8. The primary efficacy parameter was the mycologic cure rate at the follow-up weeks during treatment and 5 weeks after the end of treatment. The tolerability 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 and biochemical tests were performed at the start of the study and at the end of treatment.