An Open Label, Parallel Group Comparison Study To Evaluate the Safety Tolerability, and Pharmacokinetics of UHE-103 Cream Versus Naftin Cream in Subjects With Tinea Cruris and/or Tinea Pedis Under Maximal Use Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
This Phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (PK) of UHE 103 Cream compared to Naftin Cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or non-pregnant female 18 years of age or older.
- •Subject has provided written informed consent.
- •Subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at Visit 1/Screening;
- •Subject has a clinical diagnosis of interdigital tinea pedis with at least moderate scaling on at least 1 foot (without moccasin-type tinea pedis) and tinea cruris at Visit 1/Screening.
- •Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has any skin pathology or condition that could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
- •Subject has any clinically significant medical abnormality or history of chronic disease (cardiovascular, gastrointestinal, neurological, hematopoietic, immunosuppression [HIV], hepatic [Hepatitis B or C], psychological, renal systems, or respiratory), including conditions (e.g., gastrointestinal surgery) that may interfere with the absorption, metabolism, or excretion of investigational product.
- •Subject has used any of the following topical products on the feet or groin within 4 weeks of Visit 2/Enrollment: antifungals, antibacterials, or corticosteroid therapy.
- •Subject has applied any topical naftifine products to any part of their body within 4 weeks of Visit 2/Enrollment.
- •Subject has used topical keratolytics (e.g., urea, ammonium lactate, salicylic acid) on the feet or groin within 1 week of Visit 2/Enrollment.
- •Subject has used any other topical products on the feet or groin within 24 hours of Visit 2/Enrollment including, but not limited to non-medicated moisturizers, antipruritics, analgesics, anesthetics, etc.
- •Subject has received systemic antifungal therapy within 8 weeks or 5 half lives of the antifungal (whichever is longer) of Visit 2/Enrollment.
- •Subject is currently enrolled in an investigational drug, biologic, or device study.
- •Subject has previously been enrolled in a study for UHE-
- •Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Enrollment.
- •Subject has a history of sensitivity to any of the ingredients in the test articles.
研究组 & 干预措施
UHE-103 Cream
Subjects will apply at least a total of 4 grams* of the test article, covering both feet twice daily for 2 weeks
干预措施: UHE-103 Cream (Drug)
Naftin (naftifine hydrochloride) Cream, 2%
Subjects will apply at least a total of 5 grams* of the test article, covering the interdigital areas of both feet and to the groin once daily for 2 weeks
干预措施: Naftin (naftifine hydrochloride) Cream (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: Baseline up to Day 16
Percentage of subjects with any local and systemic AEs defined as "possibly" or "probably" or "definitely" related by the investigator.
AUC (0-12 hours)
时间窗: Day 15
Defined as the area concentration-time curve (AUC) of the active antifungal drug from time 0 to 12 hours.
Local Skin Reactions (LSRs)
时间窗: Day 16
Percentage of subjects with presence of any of the following LSRs at the end of the study: burning/stinging, edema, and oozing/vesiculation/crusting.
次要结局
未报告次要终点