Atopic Dermatitis (AD)
Conditions
Keywords
Menthol, Pruritus, Atopic dermatitis, Exosomes
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.
Interventions
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.
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.
Sponsors
Taiwan Municipal An-Nan Hospital-China Medical University
China Medical University, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
| 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). | 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. |
| 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). | 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. |
Countries
Taiwan
Outcome results
None listed