CTRI/2022/04/041890已完成不适用
A clinical study to evaluate the safety and efficacy of the baby care products on a healthy pediatric population of the age group 01-36 months.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 1.To evaluate the safety and efficacy of test products on a pediatric population by one month home use test in comparison to the baseline.
研究概览
简要总结
Study will be conducted to assess the safety and efficacy of the test products. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. For the selected subjects, the test products will be dispensed for the usage of 28 days. The assessment will be performed for week 1, 2 and 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Month(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Subjects in the age group 1-12 months, 12-24 months and 24-36 months in nearly equal ratio (both genders inclusive)
- •Subjects in general good health as determined from a recent medical history
- •Subject’s mother/authorized legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
- •Subject’s mother/authorized legal representative, preferably mother willing to abide by and comply with the study protocol.
- •Subject’s mother/legal representative agreeing not to use any other product of the same nature and change any habit or other regular products during the study period.
排除标准
- •A known history or present condition or any other concern that may require medical attention
- •Subejcts deemed unfit to participate in the study based on the general health and hygiene.
- •Babies whose parents and/or authorized legal guardian are not willing to sign the informed consent.
结局指标
主要结局
1.To evaluate the safety and efficacy of test products on a pediatric population by one month home use test in comparison to the baseline.
时间窗: 4 weeeks
2. To evaluate the skin health and quality by dermatological assessment and instrumental evaluation in comparison to the baseline.
时间窗: 4 weeeks
次要结局
未报告次要终点
研究者
研究点 (1)
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