Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis (NCT07693400) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis
Taiwan44 participantsStarted 2026-04-29
Plain-language summary
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.
Who can participate
Age range
12 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Peak Pruritus Numerical Rating Scale (PP-NRS)
Timeframe: PP-NRS will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).
Trial details
NCT IDNCT07693400
SponsorTaiwan Municipal An-Nan Hospital-China Medical University