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: 1. To investigate the safety of the moisturizing lotion for individuals with atopic eczema in Malaysia. 2. To determine the efficacy of the moisturizing lotion in improving eczema lesions among individuals with atopic eczema in Malaysia. 3. To assess the participants' satisfaction after using the moisturizing lotion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Moisturizing lotion containing Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter
USMARI Research & Innovation Centre
Petaling Jaya, Selangor, Malaysia
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).
Time frame: 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 1. = Almost clear: Just perceptible erythema and just perceptible papulation/infiltration 2. = Mild disease: Mild erythema and mild papulation/infiltration 3. = Moderate disease: Moderate erythema and moderate papulation/infiltration 4. = Severe disease: Severe erythema and severe papulation/infiltration 5. = Very severe disease: Severe erythema and severe papulation/infiltration with oozing/crusting
Time frame: 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.
Time frame: baseline, week 4
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
Time frame: 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).
Time frame: week 4
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