Evaluation of In-use Tolerance of Moisturex Baby Bathing Bar 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
Immediately after birth, the skin barrier of healthy, full-term neonates is competent, yet skin-
barrier function continues to develop through at least the first year of life. This developing
state of infant skin results in infant skin being susceptible to dryness and irritation from
external factors, such as cold weather and wind, as well as harsh topical skin-care products.
Therefore, it is critical that infant cleansers and moisturizers be well tolerated and not disrupt
the stratum corneum.
Given the importance of the skin barrier in neonates and infants, it is
important to use topical skin-care products that have undergone adequate skin-tolerance
studies, yet there are very few published studies,evaluating the tolerability or efficacy of skin
cleansers, lotions/emollients, and shampoos under real-world, normal conditions of use on
healthy, full-term neonates or infants. In this study the in use tolerance of Product will be
evaluated by use of Product on babies for a duration of 1 month, by 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, itching.(Day 30)
研究者
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.
