Efficacy of Distal Topical Application of a Traditional Chinese Medicinal Ingredient for Atopic Dermatitis and Its Exosome-Mediated Regulatory Mechanisms: Basic and Clinical Studies
| Registry | NCT07693400 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 44 (Estimated) |
| Sponsor | Taiwan Municipal An-Nan Hospital-China Medical University (Other); collaborators: China Medical University, Taiwan |
| Conditions | Atopic Dermatitis (AD) |
| Interventions | menthol-based hand and foot gloves, Sham menthol-based hand and foot gloves (Drug) |
| Dates | start 2026-04-29, primary completion 2028-02-16 (estimated), completion 2028-02-16 (estimated), first posted 2026-07-09, last updated 2026-07-09 |
| Locations | 1 site in Taiwan |
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All trials for Atopic Dermatitis (AD) All trials of menthol-based hand and foot gloves All trials of Sham menthol-based hand and foot gloves
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 8% menthol group | Experimental | Drug: menthol-based hand and foot gloves | Participants will undergo a four-week intervention, wearing the menthol gloves for five minutes once daily, following a five-days-on, two-days-off weekly schedule. Follow up the two-week tracking period of not wearing gloves. |
| sham menthol group | Sham comparator | Drug: Sham menthol-based hand and foot gloves | Participants will undergo a four-week intervention, wearing the menthol gloves for five minutes once daily, following a five-days-on, two-days-off weekly schedule. Follow up the two-week tracking period of not wearing gloves. |
Sex: All, ages: 12 Years to 100 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| An Nan Hospital, China Medical University | Tainan, Taiwan | Taiwan |