2006•Chinese Journal of MycologyRequires access
Evaluation of efficacy and safety of 2 Sertaconazole nitrate cream in the treatment of tinea corporis & cruris and tinea pedis
Aiping Wang
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Abstract
Objective To compare the efficacy and safety of Sertaconazole nitrate 2 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. Sertaconazole nitrate 2 cream and miconazole nitrate 2 cream were applied in the trial and control group respectively twice daily for 4 weeks. Patients were evaluated at 0(baseline),2,4,6 weeks.Results Sixty-one cases in the trial group and 58 cases in control group were evaluated for tinea pedis; 56 cases in the trial group and 55 cases in the control group evaluated for tinea corporis cruris.The clinical effective rates for tinea pedis at week 4 were 98.36 in the trial group and 93.10 in control group; and 100 versus 98.28 at week 6 respectively. Mycological cure rates for tinea pedis at week 4 and week 6 were both 95.1 in the trial group and both 100 in the control group. The total effective rates for tinea pedis at week 4 were 98.36 in the trial group and 93.10 in control group; and 100 versus 98.28 at week 6, respectively.The clinical effective rate for tinea corporis cruris at week 4 was 98.21 in the trial group and 92.73 in control group; and 100 versus 98.18 at week 6 respectively. Mycological cure rates for tinea corporis cruris at week 4 and week 6 were all 100 in the trial group and in the control group. The total effective rates for tinea corporis cruris at week 4 were 98.21 in the trial group and 92.73 in control group; and 100 versus 98.18 at week 6, respectively. Treatment-related adverse events consisted of local irritation, occurred in 1.7 of patients in the trial group, 0.9 in the control group. The effcacy and safety of sertaconazole nitrate 2 cream in the treatment of tinea pedis and tinea corporis cruris are similar to that of 2 miconazole nitrate cream(P0.05).Conclusion This study suggests that Sertaconazole nitrate 2 cream was effective and safe in the treatment of tinea pedis and tinea corporis cruris.