Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis

NCT07693400 | Active Not Recruiting Phase 2

• 1 other identifier: TMANH114-REC058
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis (AD)

Keywords

Menthol; Pruritus; Atopic dermatitis; Exosomes

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)

  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)

  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)

  DLQI will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).

Study Arms (2)

8% menthol group

EXPERIMENTAL

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

sham menthol group

SHAM COMPARATOR

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

Interventions

menthol-based hand and foot gloves DRUG

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.

8% menthol group

Sham menthol-based hand and foot gloves DRUG

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

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 12 years or above.
• \. Clinical diagnosis of atopic dermatitis based on Hanifin and Rajka criteria.
• \. Pruritus severity defined as PP-NRS ≥ 4.
• \. Signed the informed consent form that has been approved by the Institutional Review Board.
• \. No changes in AD medications within four weeks before enrollment and no change in dosage during the study period.

You may not qualify if:

• \. Allergy to menthol.
• \. Marked fluctuation of AD symptoms.
• \. Secondary infection of skin lesions.
• \. Severe peripheral vascular disease, skin lesions, or severe edema at hands/feet.
• \. Pregnancy or breastfeeding.
• \. Severe psychiatric conditions.
• \. With conditions such as uremia, cirrhosis, congestive heart failure with pulmonary edema, coagulation disorders, epilepsy, alcoholism, drug abuse.
• \. Unable to comply with the study protocol or unwilling to provide written consent.
• \. Participation in another clinical study within the previous month. The research team may also exclude any participant who is considered unsuitable for the study.

Sponsors & Collaborators

• China Medical University, Taiwan: collaborator
• Taiwan Municipal An-Nan Hospital-China Medical University: lead

Study Sites (1)

An Nan Hospital, China Medical University

Tainan, Taiwan, 709, Taiwan

Location

Related Publications (3)

• Silverberg JI, Barbarot S, Gadkari A, Simpson EL, Weidinger S, Mina-Osorio P, Rossi AB, Brignoli L, Saba G, Guillemin I, Fenton MC, Auziere S, Eckert L. Atopic dermatitis in the pediatric population: A cross-sectional, international epidemiologic study. Ann Allergy Asthma Immunol. 2021 Apr;126(4):417-428.e2. doi: 10.1016/j.anai.2020.12.020. Epub 2021 Jan 6.

  PMID: 33421555 BACKGROUND

• Dharmage SC, Lowe AJ, Matheson MC, Burgess JA, Allen KJ, Abramson MJ. Atopic dermatitis and the atopic march revisited. Allergy. 2014 Jan;69(1):17-27. doi: 10.1111/all.12268. Epub 2013 Oct 14.

  PMID: 24117677 BACKGROUND

• Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1.

  PMID: 32738956 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): February 16, 2028
• Study Completion (Estimated): February 16, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

TW (1)