Evaluation of the consumer safety and in vivo efficacy of baby care formulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety of product in term of Tear free claim
研究概览
简要总结
PRIMARY OBJECTIVE:The primary objective of the Consumer study is to assess the saftey (tear-free) of Head-to-Toe wash with the involvement of Pediatrician.
SECONDARY OBJECTIVE:The secondary objective of this study will be to assess the efficacy of the test product.
The evaluation is performed using:Consumer Test - Self Assessment Questionnaire
POPULATION: 100 boys & girls will be selected for this study.
The subjects selected for this study will be healthy boys & girls between the age of 1 to 3 years old
STUDY DURATION & KINETICS: The study lasts for 1 day following the first application of the product.
Observations will be done on T0, T+1 day (after application)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 3.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian subjects 2)Healthy subjects 3) Skin is healthy on the studied anatomic unit.
排除标准
- •Taking part in another study liable to interfere with this study.
结局指标
主要结局
Safety of product in term of Tear free claim
时间窗: Baseline and 1 day after product application
次要结局
- skin softness, smoothness & moisturized skin, effective cleanser, mild & gentle to skin,(Baseline & 1 day after product application)
研究者
Dr Abhishek Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.