NCT01007708已完成3 期
The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis
Dow Pharmaceutical Sciences44 个研究点 分布在 2 个国家目标入组 780 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 780
- 试验地点
- 44
- 主要终点
- Percentage of patients who achieve clinical cure
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed onychomycosis of the target nail
- •Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
- •Has a positive KOH examination from the target nail
- •Has a positive dermatophyte culture from the target nail
排除标准
- •Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
- •Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
- •Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
- •Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
研究组 & 干预措施
IDP-108
Experimental
干预措施: IDP-108 (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage of patients who achieve clinical cure
时间窗: 52 weeks
次要结局
- Percentage of patients who achieve clinical efficacy(52 weeks)
- Percentage of patients who achieve mycologic cure(52 weeks)
研究者
研究点 (44)
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