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| Name | Class |
|---|---|
| China Medical University, Taiwan | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | vIGA-AD will be assessed at Baseline (Day 1), Day 14, Day 28 (end of intervention), and Day 42 (end of study). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| An Nan Hospital, China Medical University | Tainan | Taiwan | 709 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33421555 | Background | 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. | |
| 24117677 |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| 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. |
|
| 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. | 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) | 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). |
| 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. |
| 32738956 | 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |