Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis

July 3, 2026 updated by: Chien-Chen Huang, Taiwan Municipal An-Nan Hospital-China Medical University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Tainan, Taiwan, Taiwan, 709
        • An Nan Hospital, China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 8% menthol group
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: 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 Comparator: sham menthol group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Peak Pruritus Numerical Rating Scale (PP-NRS)
Time Frame: 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.
PP-NRS will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)
Time Frame: vIGA-AD will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).
It utilizes a 5-point ordinal scale: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). Each score is anchored to specific morphologic descriptors of skin findings, such as erythema, induration/papulation, oozing/crusting, and lichenification.
vIGA-AD will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).
Eczema Area Severity Index (EASI)
Time Frame: EASI will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).
EASI is a standardized tool used to assess the severity of AD. The score integrates the involved body surface area and the severity of skin lesions. Four body regions, including the head and neck, arms, trunk, and legs, are evaluated separately. Each region is assigned a score from 1 to 6 based on the percentage of involvement. Four clinical signs, erythema, papulation or edema, excoriation and lichenification, are rated from 0 to 3. The final EASI score is calculated by the summing of the 4 regional scores, from 0 to 72.
EASI will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).
The Dermatology Life Quality Index (DLQI)
Time Frame: DLQI will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).
The index consists of ten questions with four possible responses: 'not at all', 'a little', 'a lot' or 'very much' with corresponding scores of 0, 1, 2, and 3 [48]. The total score ranges from 0 to 30.
DLQI will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiwan Municipal An-Nan Hospital-China Medical University

Collaborators

China Medical University, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2026

Primary Completion (Estimated)

February 16, 2028

Study Completion (Estimated)

February 16, 2028

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 3, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMANH114-REC058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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