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To investigate the safety and efficacy of the moisturizing lotion in improving eczema symptoms among individuals with atopic eczema in Malaysia. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4.
The main questions this study aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moisturizing lotion | Other | The moisturizing lotion contain Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter to be applied adequately by the participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moisturizing lotion | Other | Moisturizing lotion containing Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) score | The Eczema Area and Severity Index (EASI) will be assessed by a dermatologist by evaluating four body regions (head/neck, upper limbs, trunk, and lower limbs), scoring the severity of erythema, edema/papulation, excoriation, and lichenification on a 0-3 scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), estimating the percentage of skin affected in each region using a 0-6 score corresponding to 0-100% involvement, and calculating a weighted total score ranging from 0 (no eczema) to 72 (most severe eczema). | baseline, week 4 |
| Investigator's Global Assessment (IGA) score | IGA will be scored by a dermatologist to assess atopic eczema severity using a 6-point scale: 0 = Clear: No inflammatory signs of atopic eczema
| baseline, week 4 |
| Overall Dry Skin (ODS) score | Visual dryness will be scored by a dermatologist using the Overall Dry Skin (ODS) scale, where 0 indicates no dryness and 4 indicates marked dryness characterized by large scales, pronounced roughness, redness, eczematous changes, or cracks. | baseline, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The safety of the moisturizing lotion will be evaluated throughout the study by monitoring adverse events (AEs) reported by participants. The product tolerability will be evaluated using a self-administered questionnaire at week 4. Participants will be asked to rate their level of redness, stinging sensation, tightening, itching, dryness, scaling, and burning on a 6-point scale, with 0 indicating 'none' and 5 indicating 'very severe |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USMARI Research & Innovation Centre | Recruiting | Petaling Jaya | Selangor | 47810 | Malaysia |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| 4 weeks |
| Participant satisfaction | Participation satisfaction towards product efficacy will be evaluated using a survey. Participants rated their level of agreement with each statement using a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = not sure, 4 = agree, 5 = strongly agree). | week 4 |