CTRI/2025/04/084280尚未招募不适用
Evaluation of moisturizing effect of Moisturex Baby Moisturizing Lotion in babies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1. Skin Hydration using MoistureMeter SC after product application.
研究概览
简要总结
The test product is a moisturizing lotion. Moisturizers, or emollients, are chemical mixtures designed to soften and make the skin more pliable. They function as occlusives (e.g., petrolatum, waxes), humectants (e.g., glycerin, urea), or emollients (smoothen skin by filling spaces between flakes with oil). This study aims to evaluate the lotion’s moisturizing effect on babies’ skin and check for any irritation post-application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Month(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •Healthy babies with dry skin and/or normal skin determined clinically.
- •Between 3 months and 24 months of age.
- •Parents accepting not to use products with the same end benefit on babies during the entire study duration.
- •Parents cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •Parents having signed a Consent Form after being informed orally and in writing of all information concerning the study procedures and study objectives.
排除标准
- •Skin allergy antecedents or atopic subject.
- •Hypersensitivity to any cosmetic product, raw material.
- •Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
- •Babies on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month).
结局指标
主要结局
1. Skin Hydration using MoistureMeter SC after product application.
时间窗: 12 hour
次要结局
- 1.Skin Hydration using MoistureMeter SC at 24 hours after product application(2.TEWL measurements using VapoMeter at 12 hours and 24 hours after product application.)
研究者
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.
研究点 (1)
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