Efficacy of Distal Topical Application of a Traditional Chinese Medicinal Ingredient for Atopic Dermatitis and Its Exosome-Mediated Regulatory Mechanisms: Basic and Clinical Studies
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The Peak Pruritus Numerical Rating Scale (PP-NRS)
研究概览
简要总结
The goal of this clinical trial is to learn if menthol works to relieve pruritus in atopic dermatitis. The primary objectives are to evaluate the safety and clinical efficacy of menthol-containing gloves and foot-covers, specifically whether they can improve patient-reported Peak Pruritus Numerical Rating Scale (PP-NRS). Secondary objectives include assessing the Eczema Area Severity Index (EASI), the Dermatology Life Quality Index (DLQI), biochemical examinations (including white blood cell count, hemoglobin, GOT, GPT, creatinine, platelet count, and HbA1c), and exosome analysis. Participants will be asked to: Wear menthol-containing gloves and foot-covers (or shams) for 5 minutes per session, following a schedule of 5 consecutive days of use and 2 days of rest each week, over a total period of 28 days. Attend clinic visits on Days 1, 14, 28, and 42 for evaluations and tests.
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
- 12 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age 12 years or above.
- •2. Clinical diagnosis of atopic dermatitis based on Hanifin and Rajka criteria.
- •3. Pruritus severity defined as PP-NRS ≥
- •4. Signed the informed consent form that has been approved by the Institutional Review Board.
- •5. No changes in AD medications within four weeks before enrollment and no change in dosage during the study period.
排除标准
- •1. Allergy to menthol.
- •2. Marked fluctuation of AD symptoms.
- •3. Secondary infection of skin lesions.
- •4. Severe peripheral vascular disease, skin lesions, or severe edema at hands/feet.
- •5. Pregnancy or breastfeeding.
- •6. Severe psychiatric conditions.
- •7. With conditions such as uremia, cirrhosis, congestive heart failure with pulmonary edema, coagulation disorders, epilepsy, alcoholism, drug abuse.
- •8. Unable to comply with the study protocol or unwilling to provide written consent.
- •9. Participation in another clinical study within the previous month. The research team may also exclude any participant who is considered unsuitable for the study.
结局指标
主要结局
The Peak Pruritus Numerical Rating Scale (PP-NRS)
时间窗: PP-NRS will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).
This scale uses an 11-point score, from 0 (no itch) to 10 (worst imaginable itch). The scale evaluates the peak pruritus during the past 24 hours.
次要结局
- The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)(vIGA-AD will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).)
- Eczema Area Severity Index (EASI)(EASI will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).)
- The Dermatology Life Quality Index (DLQI)(DLQI will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).)
研究者
Chien-Chen Huang
M.D., PhD
Taiwan Municipal An-Nan Hospital-China Medical University