Evaluation of efficacy and safety of 1% isoconazole nitrate cream in the treatment of tinea pedis and tinea corporis & cruris

Objective To compare the efficacy and safety of isoconazole nitrate 1% cream and miconazole nitrate 2% cream in the treatment of tinea pedis and tinea corporis cruris.Methods A multi-center,double-blind,randomized controlled trial was conducted.Isoconazole nitrate 1% cream and miconazole nitrate 2% cream were applied in the lesions of the trial and control group respectively twice daily for 4 weeks to tinea pedis and for 2 weeks to tinea corporis cruris.Results Seventy-one cases in the trial group and 72 cases in control group were evaluated for tinea pedis;73 cases in the trial group and 73 cases in the control group were evaluated for tinea corporis cruris.The clinical effective rate of tinea pedis in forth week was 87.3% in the trial group and 87.5% in control group;and 88.7% versus 91.7% in the sixth week respectively.Mycological cure rate of tinea pedis in forth week was 83.1% in the trial group and 94.4% in control group;and 84.5% versus 90.3% in the sixth week respectively.The total effective rate of tinea pedis in forth week was 77.5% in the trial group and 86.1% in control group;and 78.9% versus 86.1% at week 6 respectively.The clinical effective rate of tinea corporis cruris in the second week was 87.7% in the trial group and 93.2% in control group;and 91.8% versus 94.5% at week 4 respectively.Mycological cure rates for tinea corporis cruris at week 2 were 82.2% in the trial group and 89.0% in control group;and 89.0% versus 93.2% at week 4 respectively.The total effective rates of tinea corporis cruris in second week was 78.1% in the trial group and 86.3% in control group;and 87.7% versus 93.2% at week 4 respectively.Treatment-related adverse events consisted of local irritation,itching,burn or erythema,occurred in 2.1% of patients in the trial group,in 1.4% of patients in the control group.The effcacy and safety of isoconazole nitrate 1% cream in the treatment of tinea pedis and tinea corporis cruris are similar to that of miconazole nitrate 2% cream(P0.05).Conclusion This study suggests that isoconazole nitrate 1% cream was effective and safe in the treatment of tinea pedis and tinea corporis cruris.