Clinical Evaluation of the Skin Microbiome and the Efficacy of an Over-The-Counter (OTC) Drug for Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Skin Microbiome Composition and Diversity using qPCR analysis
研究概览
简要总结
This is a research study. The over-the-counter (OTC) drug for atopic dermatitis being tested is not approved as a treatment for the participants' atopic dermatitis condition. In participating in this study, the investigators will analyze the participants' skin microbiome, measure skin hydration and barrier function, and assess clinical improvements to help us understand the potential impact of the investigational OTC drug on atopic dermatitis and skin microbiome balance.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously diagnosed Atopic Dermatitis with active, visible flare-ups at time of screening
- •Present dry/itchy skin patches on forearm, back of the hand, or posterior lower leg suitable for treatment assessment
- •Evidence of inflammatory disease (documented diagnosis and current active symptoms)
- •Stable skincare routine for 4 weeks prior to screening
- •Subject willing to avoid conflicting topical treatments during study period
- •Subject being used to applying topical treatments for atopic dermatitis
- •Healthy subject apart from atopic dermatitis
- •Subject having given free informed, written consent
- •Subject willing to adhere to protocol and study procedures
排除标准
- •Pregnant or nursing woman or woman planning to get pregnant during the study
- •Recent (within 4 weeks) or current history of using atopic dermatitis biological drugs, such as dupilumab, lebrikizumab, nemolizumab, and tralokinumab
- •Recent use of systemic antibiotics, steroids, or immunomodulators (within 4 weeks)
- •Active skin infections unrelated to atopic dermatitis
- •Severe dermatologic conditions requiring immediate medical intervention
- •Use of topical or systemic treatment during previous weeks liable to interfere with assessment
- •Subject having undergone surgery under general anaesthesia within the previous month
- •Excessive exposure to sunlight or UV-rays within the previous month
- •Subject having scars, tattoos on the forearms that would interfere with assessments
- •Subject enrolled in another clinical trial during the study period and/or during the past 30 days
研究组 & 干预措施
Atopic Dermatitis OTC Product
干预措施: OTC Drug for Atopic Dermatitis in Cream form (Drug)
结局指标
主要结局
Skin Microbiome Composition and Diversity using qPCR analysis
时间窗: 4 weeks
Trans-Epidermal Water Loss Measurement via Vapometer
时间窗: 4 weeks
Moisturizing effect by measurement of cutaneous hydration via MoistureMeterSC
时间窗: 4 weeks
Skin barrier lipid composition and integrity via lipidomic profiling analysis
时间窗: 4 weeks
次要结局
- Before and After Treated Arm Itching Assessment(4 weeks)
- Before and After Treated Arm Redness Assessment(4 weeks)
- Before and After Treated Arm Skin Dryness Assessment(4 weeks)
- Monitoring of Atopic Dermatitis/Eczema Severity(4 weeks)