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NCT Number: NCT07693400

Topical Chinese Medicine and Exosome Mechanisms for Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

An Nan Hospital, China Medical University

Tainan, Taiwan, 709

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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-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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Taiwan Municipal An-Nan Hospital-China Medical University

Other

Collaborators

  • China Medical University, Taiwan

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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