复方联苯苄唑溶液治疗伴有细菌感染的浅部真菌病(足癣)有效性和安全性的单中心随机开放单药对照ⅡC临床试验
[Translation] Efficacy and safety of compound bifonazole solution in the treatment of superficial mycosis with bacterial infection (tinea pedis): a single-center randomized open-label single-drug controlled IIC clinical trial
在联苯苄唑氯己定喷雾剂Ⅱ期(A、B)临床试验基础上,采用单中心、随机、开放试验方法,进一步验证联苯苄唑氯己定喷雾剂治疗伴有细菌感染的浅部真菌病(足癣)的有效性和安全性单中心、随机、开放、联苯苄唑溶液、夫西地酸乳膏Ⅱ期(C)临床试验,为药物Ⅲ期临床试验提供参考资料。
[Translation] On the basis of the phase II (A, B) clinical trial of bifonazole and chlorhexidine spray, a single-center, randomized, open trial method was used to further validate the treatment of bifonazole and chlorhexidine spray in the treatment of shallow patients with bacterial infection. Single-center, randomized, open-label, phase II (C) clinical trial of bifonazole solution and fusidic acid cream on the efficacy and safety of tinea pedis (tinea pedis), providing reference data for phase III clinical trials of the drug.
复方联苯苄唑溶液治疗伴有细菌感染的浅部真菌病有效性和安全性的多中心、随机双盲Ⅱ期(B)临床研究
[Translation] A multicenter, randomized, double-blind phase II (B) clinical study on the efficacy and safety of compound bifonazole solution in the treatment of superficial mycosis with bacterial infection
试验目的是研究复方联苯苄唑溶液不同浓度对伴有细菌感染的浅部真菌病的治疗作用和安全性,为Ⅲ期临床试验研究设计和给药剂量方案的确定提供依椐
[Translation] The purpose of the experiment is to study the therapeutic effect and safety of different concentrations of compound bifonazole solution on superficial mycosis accompanied by bacterial infection, and to provide basis for the design of phase III clinical trial and the determination of dosing schedule.
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