NCT02343627已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Safety and Efficacy of NVXT Solution in Patients With Mild-to-Moderate Fungal Infection of the Toe Nail
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
- 47
- 主要终点
- Number of Participants With Negative Fungal Culture
研究概览
简要总结
This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.
详细描述
This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed onychomycosis
- •Presence of dermatophyte fungal infection with no current topical or systemic antifungal therapy
- •Clinical diagnosis of mild-to-moderate fungal infection of at least one toe involving 10-50% of the nail area, without involvement of one of the lunular proximal regions
- •Positive potassium hydroxide mount preparation
- •Positive fungal culture for a dermatophyte
排除标准
- •Nail or anatomical abnormalities of the toe that may interfere with evaluations or dosing compliance
研究组 & 干预措施
NVXT Solution
Experimental
NVXT Solution once daily for 60 days
干预措施: NVXT Solution (Drug)
Vehicle of test product
Placebo Comparator
Vehicle of test product, once daily for 60 days
干预措施: Vehicle of test product (Drug)
结局指标
主要结局
Number of Participants With Negative Fungal Culture
时间窗: 28 days
To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days
次要结局
未报告次要终点
研究者
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