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Clinical Trials in China / NCT07693400
Active, not recruiting Phase 2

Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis

NCT07693400 · tracked via the Priya Life Science China tracker
Sponsor
Taiwan Municipal An-Nan Hospital-China Medical University
Phase
Phase 2
Started
2026-04-29
Last updated
2026-07-09

Condition(s) studied

Atopic Dermatitis (AD)

Investigational drug(s) / intervention(s)

menthol-based hand and foot glovesSham menthol-based hand and foot gloves

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-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.

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The Peak Pruritus Numerical Rating Scale (PP-NRS) — 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.

Trial sites (1)

FacilityCityRegionStatus
An Nan Hospital, China Medical University Tainan Taiwan

More Taiwan Municipal An-Nan Hospital-China Medical University trials in China

Topical Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy Active, not recruiting

Other trials for the same condition

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profiles of TLL-018 in Patients With Moderate-to-Severe Atopic Dermatitis Starting soon
A Study for HSK44459 in Participants With Atopic Dermatitis Active, not recruiting
A Phase III Study of GS101 Injection to Dupixent® Recruiting
The Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching Starting soon
A Long-term Safety and Efficacy Study Evaluating CM512 in Atopic Dermatitis. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07693400 on ClinicalTrials.gov ↗ ← All trials in China