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【ChiCTR1900027348】研究伦理审批文件无法正常显示,请重新上传。 Treatment of onychomycosis with fractional CO2 laser combined with topical anti fungul-A multicenter randomized controlled trial

基本信息
登记号

ChiCTR1900027348

试验状态

结束

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2019-11-09

临床申请受理号

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靶点

/

适应症

Onychomycosis

试验通俗题目

研究伦理审批文件无法正常显示,请重新上传。 Treatment of onychomycosis with fractional CO2 laser combined with topical anti fungul-A multicenter randomized controlled trial

试验专业题目

Treatment of onychomycosis with fractional CO2 laser combined with topical anti fungul-A multicenter randomized controlled study

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

To statistically compare the efficacy and safety of Fractional CO2 laser combined with topical antifungal and only topical antifungal in multiple centers.

试验分类
试验类型

随机平行对照

试验分期

其它

随机化

Blocked randomized sequence was generated by SAS 9.4 statistical software and with a 1:1 allocation between two groups. It was done by a statistician who was not involved in the trial.

盲法

Not stated

试验项目经费来源

上海申康医院发展项目

试验范围

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目标入组人数

80

实际入组人数

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第一例入组时间

2016-12-01

试验终止时间

2019-06-30

是否属于一致性

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入选标准

(1) aged 18-75 years; (2) unbiased to gender; (3) diagnosis confirmed through fungal test (direct microscopic using KOH and culture in Sabouraud dextrose agar medium, at 28 degree C for 7 days); (4) signed a written consent to be enrolled in the study.;

排除标准

(1) if they had systemic treatment of the disease 48 weeks prior to the enrollment in our survey; (2) if they did nail dying; (3) if they are under photosensitive drugs; (4) pregnant women; (5) who have sub-ungula hemorrhage or sub-ungula nevus; (6) patients with combined other diseases such as psoriasis, Wilsons Lichen, atopic dermatitis that might cause nail deformity.;

研究者信息
研究负责人姓名
试验机构

上海申康医院发展项目

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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