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Atopic Dermatitis (AD)Phase 2NCT07693400

Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis

A Phase 2 study testing menthol-based hand and foot gloves in people with Atopic Dermatitis (AD), run by Taiwan Municipal An-Nan Hospital-China Medical University at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 100 years
Conditions the study is for
Atopic Dermatitis (AD)
What is being tested?
menthol-based hand and foot gloves
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteTaiwan
Study dates
29 Apr 2026to 16 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • An Nan Hospital, China Medical University

    Tainan, Taiwan, 709

Other trials in Taiwan

About this study

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

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.

Being tested
menthol-based hand and foot gloves, Sham menthol-based hand and foot gloves
Keywords
Menthol, Pruritus, Atopic dermatitis, Exosomes
Medical subject headings
Dermatitis, Atopic, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • menthol-based hand and foot glovesDrug

    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 glovesDrug

    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 groups in NCT07693400
Study groupRoleWhat they receive
8% menthol groupExperimentalParticipants 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.
Receives: Drug: menthol-based hand and foot gloves
sham menthol groupSham comparatorParticipants 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.
Receives: Drug: Sham menthol-based hand and foot gloves

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

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

    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.

    Measured: vIGA-AD will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study).

  2. Eczema Area Severity Index (EASI)

    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.

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

  3. The Dermatology Life Quality Index (DLQI)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start29 Apr 2026
  3. Primary completion16 Feb 2028 (estimated)
  4. Study completion16 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07693400
Sponsor's protocol ID
TMANH114-REC058
Status last verified
Jul 2026
First submitted
3 Jul 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33421555

  • 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.

    PubMed 24117677

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

    PubMed 32738956

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing menthol-based hand and foot gloves in people with Atopic Dermatitis (AD), run by Taiwan Municipal An-Nan Hospital-China Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07693400, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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