Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis

Efficacy of Distal Topical Application of a Traditional Chinese Medicinal Ingredient for Atopic Dermatitis and Its Exosome-Mediated Regulatory Mechanisms: Basic and Clinical Studies

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.

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.