Clinical Evaluation of a Soothing Moisturizing Lotion in Individuals With Atopic Eczema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Eczema Area and Severity Index (EASI) score
研究概览
简要总结
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:
- To investigate the safety of the moisturizing lotion for individuals with atopic eczema in Malaysia.
- To determine the efficacy of the moisturizing lotion in improving eczema lesions among individuals with atopic eczema in Malaysia.
- To assess the participants' satisfaction after using the moisturizing lotion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Malaysian women and men
- •Age above 18 years old
- •Clinically diagnosed with eczema with mild to moderate severity on any parts of the body as evaluated by Eczema Area and Severity Index (EASI) (score 10-20).
排除标准
- •History of allergies or adverse reactions to moisturizers or components of the specific products being tested
- •History of chronic allergies
- •Pregnant, breastfeeding women, or those planning pregnancy during the study period
- •Participants with documented autoimmune diseases.
- •Currently undergoing or requiring active drug treatment for atopic dermatitis or eczema
- •Use of any medication (topical or systemic) that could interfere with the study aim (e.g. corticosteroids, calcineurin inhibitors, methotrexate) 3 months prior to the start of the study treatment and throughout the study
- •Current participation in another interventional clinical study
- •Presence of dermatological or systemic disorder other than eczema that could interfere with study outcomes
研究组 & 干预措施
Moisturizing lotion
The moisturizing lotion contain Leontopodium alpinum (Edelweiss) extract, Macadamia ternifolia seed oil, and Butyrospermum parkii (shea) butter to be applied adequately by the participants
干预措施: Moisturizing lotion (Other)
结局指标
主要结局
Eczema Area and Severity Index (EASI) score
时间窗: baseline, week 4
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).
Investigator's Global Assessment (IGA) score
时间窗: baseline, week 4
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
Overall Dry Skin (ODS) score
时间窗: baseline, week 4
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.
次要结局
- Participant satisfaction(week 4)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](4 weeks)