NCT01431820已完成2 期
Safety and Efficacy of Luliconazole Solution, 10% With Two Dosing Regimens in Distal Subungual Onychomycosis of the Toenails: A Randomized, Double-Blind, Vehicle-Controlled, Phase 2B/3 Study
Topica Pharmaceuticals0 个研究点目标入组 334 人开始时间: 2012年5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
- 334
- 主要终点
- The proportion of subjects who achieve complete cure of the target great toenail
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails.
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
- Triple (Participant, Care Provider, 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
- •Subjects of either gender, any race and between the ages of 18 and 70 inclusive
- •Subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (DSO) - Subjects must be free of any disease that in the Investigator's opinion might interfere with the study evaluations or jeopardize the subject's safety
排除标准
- •Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution
- •Subjects who are currently participating or have recently participated in another investigational medication or device study
研究组 & 干预措施
Luliconazole Solution, 10% Regimen 1
Experimental
干预措施: Luliconazole Solution, 10% (Drug)
Luliconazole Solution, 10% Regimen 2
Experimental
干预措施: Luliconazole Solution, 10% (Drug)
Vehicle Solution Regimen 1
Placebo Comparator
干预措施: Vehicle Solution (Drug)
Vehicle Solution Regimen 2
Placebo Comparator
干预措施: Vehicle Solution (Drug)
结局指标
主要结局
The proportion of subjects who achieve complete cure of the target great toenail
时间窗: Week 52
次要结局
未报告次要终点
研究者
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