A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Complete Cure at End of Study
研究概览
简要总结
The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.
详细描述
UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female, 16 years of age or older.
- •Clinical diagnosis of moccasin type tinea pedis
- •Microscopic evidence (positive KOH) of the presence of fungi
- •Provided written informed consent/assent
- •In general good health
排除标准
- •Pregnant or lactating or planning to get pregnant while on the study
- •Has concurrent tinea infection (e.g., tinea versicolor, tinea cruris)
- •Other skin disease which might interfere with the evaluation of tinea pedis
- •History of diabetes mellitus or is immunocompromised
- •Currently enrolled in an investigational drug or device study
- •Used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Study Day 1)/Baseline
- •Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
研究组 & 干预措施
UHE-103A1 cream
Topical cream applied twice daily for 2 weeks.
干预措施: UHE-103A1 cream (Drug)
UHE-103A2 cream
Topical cream applied twice daily for 2 weeks.
干预措施: UHE-103A2 cream (Drug)
UHE-103B cream
Topical cream applied twice daily for 2 weeks.
干预措施: UHE-103B cream (Drug)
UHE-103A1B cream
Topical cream applied twice daily for 2 weeks.
干预措施: UHE-103A1B cream (Drug)
UHE-103A2B cream
Topical cream applied twice daily for 2 weeks.
干预措施: UHE-103A2B cream (Drug)
结局指标
主要结局
Complete Cure at End of Study
时间窗: Day 43
Proportion of subjects with Complete Cure (negative fungal test \& no clinical disease-induced signs and symptoms) at end of study (EOS).
次要结局
- Effective treatment(Day 43)
- Mycological Cure(Day 43)