A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TA103 and Placebo Control in the Treatment of Tinea Pedis.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46)
研究概览
简要总结
To evaluate and compare the safety and efficacy of TA103 in the treatment of tinea pedis.
详细描述
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing TA103 and the placebo control in the treatment of tinea pedis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or non pregnant female aged ≥ 18 years
- •Subjects must have provided IRB approved written informed consent
- •Subjects must have clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •Subjects with a history of hypersensitivity or allergy to any of the study medication ingredients and its excipients.
- •Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
研究组 & 干预措施
TA103
The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
干预措施: TA103 (Drug)
Placebo Control
The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
干预措施: Placebo Control (Drug)
结局指标
主要结局
The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46)
时间窗: Baseline to Week 6 Visit
To evaluate safety and efficacy of TA103
次要结局
未报告次要终点