A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability Patients With Mild to Moderate Onychomycosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
研究概览
简要总结
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis
详细描述
Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).
排除标准
- •Females who are pregnant, lactating or likely to become pregnant during the study.
研究组 & 干预措施
NVXT topical
daily dosing for one 8-week treatment period (Treatment Group A) and two 8-week treatment periods separated by a 32-week rest period (Treatment Group B),
干预措施: NVXT topical (Drug)
Placebo (Vehicle) Topical
two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),
干预措施: Placebo (Vehicle) Topical (Drug)
结局指标
主要结局
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure
时间窗: Day 141
Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail
次要结局
- Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure(Day 141)
- Number of Patients in Each Treatment Group With a Complete Clinical Cure(Day 141)
- Number of Patients in Each Treatment Group With a Mycological Cure(Day 141)
- Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure(Day 141)