NCT02436291Unknown4 期
Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis
MB Mazor Ltd.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Nail cure as measured by measured by length of healthy nail of at least 5 mm
研究概览
简要总结
Open label study to evaluate the efficacy of CURE-EX device in the treatment of onychomycosis.
详细描述
Each affected nail will be treated twice daily for 24-30 weeks. Efficacy will be evaluated by measuring the growth of healthy nail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with clinical and mycological onychomycosis (by culture and smear).
- •Subjects did not receive topical antifungal treatment during the 14 days prior to commencing the study.
- •Subjects did not receive any systemic antifungal treatment during the 3 months prior to the start of the study.
排除标准
- •lunula infected with onychomycosis.
- •Pregnant or breast feeding female.
结局指标
主要结局
Nail cure as measured by measured by length of healthy nail of at least 5 mm
时间窗: 24-30 weeks
Cure measured by length of healthy nail of at least 5 mm
Nail cure as measured by culture and smear
时间窗: 24-30 weeks
Nail culture and smear
次要结局
未报告次要终点
研究者
研究点 (1)
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