NCT00777868已完成2 期
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
Dow Pharmaceutical Sciences10 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 10
- 主要终点
- Change from baseline in area of infected nail
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of onychomycosis of the target toenail
- •A positive fungal culture from the target toenail
排除标准
- •Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations
- •Presence of tinea pedis (athletes foot)
- •Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
研究组 & 干预措施
1
Experimental
干预措施: Low Strength IDP-108 (Drug)
2
Experimental
干预措施: High Strength IDP-108 (Drug)
3
Experimental
干预措施: High Strength IDP-108 under occlusion (Drug)
4
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Change from baseline in area of infected nail
时间窗: 9 months
次要结局
- Change from baseline in mycological results(9 months)
研究者
研究点 (10)
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