Multicenter, double-blind, randomized controlled sdudy on sertaconazole 2% cream and miconazole 2% cream in the treatment of tinea pedis and tinea corporis and cruris

Objective To compare the efficacy and safety of sertaconazole 2% cream and miconazole 2%cream in the treatment of tinea pedis and tinea corporis and cruris. Methods A multicenter, double-blind, randomized controlled trial was conducted. Sertaconazole 2% cream and miconazole 2%cream were applied in the trial and control group respectively twice daily for 4 weeks. Patients were evaluated at 0 (baseline), weeks 2,4, 6. Results Sixty six cases in the trial group and 61 cases in control group were evaluated for tinea pedis; 62 cases in the trial group and 64 cases in the control group were evaluable for tinea corporis and cruris. The clinical effective rates for tinea pedis at week 4 were 90.9% in the trial group and 91.8% in control group; and 100% versus 98.4% at week 6, respectively. Mycological cure rates for tinea pedis at week 4 were 89.2% in the trial group and 91.8% in the control group; and 95.5% versus 93.4% at week 6, respectively. The total effective rates for tinea pedis were 93.9% versus 90.2%, respectively. The clinical effective rates for tinea corporis and cruris at week 4 were 96.8% in the trial gr.oup and 100% in the control group; and 98.4% versus 98.4% at week 6, respectively. Mycological cure rates for tinea corporis and cruris at week 4 were 100% in the trial group and 98.4% in the control group; and 100% versus 98.4% at week 6, respectively. The total effective rates were 98.4% versus 96.9%, respectively. Treatment-related adverse events consisted of mild local irritation, occurred in 3.1% of patients in the trial group, 2.4% in the control group. Conclusion This study suggest that sertaconazole 2% cream were safe and effective in the treatment of tinea pedis and tinea corporis and cruris.