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ACTIVE NOT RECRUITING
NCT07693400
PHASE2

Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis

Sponsor: Taiwan Municipal An-Nan Hospital-China Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2026-04-29

Completion Date

2028-02-16

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

An Nan Hospital, China Medical University

Tainan, Taiwan, Taiwan