Evaluation of In-use Tolerance 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
- 35
- 试验地点
- 1
- 主要终点
- Clinical evaluation of skin for erythema and oedema using Draize scale.
研究概览
简要总结
Healthy, full-term babies have a competent skin barrier at birth, but as it develops, infant skin becomes prone to dryness and irritation from external factors like cold weather, wind, and certain skincare products. Infant skin is also exposed to saliva, nasal secretions, urine, feces, and dirt, which can disrupt the skin barrier. Proper cleansing is crucial for maintaining skin-barrier function. Despite the importance of this, there are few studies evaluating the tolerability of skincare products in healthy infants. This study will assess the tolerance of the product in babies for one month, based on clinical evaluation and parent feedback.
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
- •Apparently healthy babies in the age group: 3 months to 24 months.
- •Parents of babies agreeing to give feedback regarding product.
- •Parents of babies agreeing to use the Product as directed.
- •The parents are willing to provide written informed consent for babies to participate in the study.
- •Having valid proof of identity and age of babies.
排除标准
- •Any kind of other skin diseases/conditions
- •Babies with atopic dermatitis
- •Presence of systemic illness.
结局指标
主要结局
Clinical evaluation of skin for erythema and oedema using Draize scale.
时间窗: Day 30
次要结局
- Assessment questionnaire for parents for recording skin intolerances like redness, oedema, cutaneous dryness, roughness and itching or any other problems.(Day 30)
研究者
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.)