The safety and efficacy of sertaconazole nitrate cream 2% for tinea pedis.

To determine the safety and efficacy of topical sertaconazole nitrate cream 2% in the treatment of tinea pedis, 2 randomized, multicenter, double-blinded, parallel group, vehicle-controlled studies were conducted. A total of 588 subjects were enrolled, and 383 subjects were randomized to treatment with sertaconazole or vehicle applied twice daily for 4 weeks. Improvements in symptoms were noted at week 1 in the active treatment group. At week 4, mycologic cure was seen in 70.3% of sertaconazole-treated subjects and 36.7% of vehicle-treated subjects (P<.0001). At week 6, 46.7% of sertaconazole-treated subjects had successful treatment outcomes compared with 14.9% of vehicle-treated subjects (P<.0001). No serious adverse events were reported, and rates of cutaneous adverse events were comparable between treatment groups. In conclusion, sertaconazole nitrate cream 2% was well-tolerated, offered rapid relief of symptoms, and achieved high rates of mycologic cure. The stability of the mycologic cure rates through weeks 5 and 6 (2 weeks after cessation of therapy) indicate that sertaconazole protects against reinfection.