Three-Arm Trial of Novel Treatment for Tinea Pedis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Effective Treatment (Mycological Cure and Minimal Symptoms)
研究概览
简要总结
This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the treatment relative to an existing gold-standard treatment. Patients will be treated for four weeks, with their condition being assessed at the end of treatment and two weeks after the end of treatment. The primary endpoint for this study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and minimal clinical signs & symptoms. Secondary endpoints include safety and patient evaluation of treatment.
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
- 否
入选标准
- •male or female, aged 18 or above
- •clinical diagnosis of tinea pedis
- •diagnosis confirmed with potassium hydroxide microscopy
- •availability for the duration of the study (6 weeks)
- •willingness to comply with study protocol
- •informed consent
排除标准
- •moccasin-type tinea pedis
- •severe maceration of interdigital spaces
- •severe fissuring
- •history of dry feet, cracking, fissuring
- •concurrent onychomycosis
- •serous exudate or pus
- •topical antifungal treatment in the past 2 weeks
- •systemic antifungal treatment in the past 4 weeks
- •concurrent immunosuppressive or antimicrobial therapy
- •liver disease
- •pregnancy or breastfeeding
- •known hypersensitivity to any ingredients of trial agents
研究组 & 干预措施
Experimental Treatment
Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks.
干预措施: Experimental Drug SESC 01 (Drug)
Vehicle Control
Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks.
干预措施: Placebo (Drug)
Active Comparator
Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks.
干预措施: Terbinafine Hydrochloride (Drug)
结局指标
主要结局
Effective Treatment (Mycological Cure and Minimal Symptoms)
时间窗: 6 weeks
Binary outcome measure defined as mycological cure AND a total clinical assessment score less than or equal to 2 (out of a possible 18). Mycological cure is defined as negative potassium hydroxide microscopy, while the clinical assessment is based on a sum of 6 symptoms (desquamation, vesiculation, erythema, fissuring, maceration, and pruritus) scored 0-3 by a physician.
次要结局
- Rate of Adverse Events(6 weeks)
- Effective Treatment (Mycological Cure and Minimal Symptoms)(4 weeks)
- Patient Satisfaction Score(4 weeks)
- Self-Reported Patient Compliance(4 weeks)