NCT01208129终止3 期
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 458
- 试验地点
- 23
- 主要终点
- Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.
研究概览
简要总结
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 fungal infection of the toenail as assessed by study doctor
- •koh positive & dermatophyte culture positive at Visit 1
- •general good health as assessed by study doctor
排除标准
- •severe fungal toenail infection
- •prior use of antifungal drugs (wash-out allowed, duration varies on class)
- •significant confounding conditions as assessed by study doctor
- •pregnancy/lactation
- •must forego nail salon procedures during study for at least ~60 weeks
研究组 & 干预措施
Vehicle alone
Placebo Comparator
干预措施: Placebo control (Drug)
Active drug
Experimental
干预措施: NAB001 (Drug)
结局指标
主要结局
Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure.
时间窗: Week 56 after 52 weeks of treatment
次要结局
- Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (clear or almost clear).(Week 56)
研究者
研究点 (23)
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