NCT00453271已完成2 期
A Randomized, Double-Blind, Parallel-Group,Multicenter, Dose-Response, Vehicle-Controlled Study of the Safety and Efficacy of NB-002 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
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
- 443
- 试验地点
- 24
- 主要终点
- Planimetry assessment of the target great toenail
研究概览
简要总结
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
详细描述
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are healthy males or females between the ages of 18 and 75 years of age;
- •have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
- •positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
- •refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
- •are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
排除标准
- •females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- •are hypersensitive to topical creams, ointments, medications, or surfactants;
- •have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
- •have taken any investigational drug within 4 weeks prior to the start of the study.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
NB-002 0.25% BID
Experimental
干预措施: NB-002 (Drug)
NB-002 0.5% QD
Experimental
干预措施: NB-002 (Drug)
NB-002 0.5% BID
Experimental
干预措施: NB-002 (Drug)
Vehicle control
Sham Comparator
干预措施: Vehicle control (Drug)
结局指标
主要结局
Planimetry assessment of the target great toenail
时间窗: Week 24
Rate of complete cure
时间窗: Week 46
Rate of therapeutic success
时间窗: Week 46
次要结局
- Investigator's visual assessment of length of new unaffected nail
- The presence/absence of DSO on all toenails
研究者
研究点 (24)
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