NCT02022215已完成2 期
A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of ME1111 in Patients With Mild to Moderate Onychomycosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 304
- 主要终点
- Complete cure rate at Week 52
研究概览
简要总结
The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
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
- •Mild to moderate distal lateral subungual onychomycosis
- •A positive potassium hydroxide (KOH) microscopy
- •A positive fungal culture for a dermatophyte
- •Good general health
排除标准
- •Uncontrolled diabetes
- •Onychomycosis of the fingernails
- •Prior use of antifungal drugs (Failure to complete the specified washout period)
- •History of HIV, Hepatitis B or Hepatitis C
- •Diagnosis of psoriasis or history of psoriasis
- •Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- •Pregnancy/lactation
研究组 & 干预措施
ME1111 Solution, Low strength
Experimental
干预措施: ME1111 Solution, Low strength (Drug)
ME1111 Solution, High strength
Experimental
干预措施: ME1111 Solution, High strength (Drug)
Matching Vehicle Solution
Placebo Comparator
干预措施: Matching Vehicle Solution (Drug)
结局指标
主要结局
Complete cure rate at Week 52
时间窗: Week 52
complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.
次要结局
- Complete or almost complete cure rate at Week 52(Week 52)
- Local Tolerability Assessments(Up to Week 48, Week 52, EOS)
- Number of Adverse events(Up to Week 48, Week 52, EOS)
研究者
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