Safety In-Use Study to Assess the Cutaneous Tolerance of Tear Free Baby body wash and Shampoo in Healthy Babies of 0 to 36 Months of Age.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1 The safety of the test product will be evaluated on the skin in terms of mildness, gentleness and non-irritability of babies’ skin using pediatrician assessment
研究概览
简要总结
This study isproposed to evaluate and establish the benefits of the test product onmildness, gentleness and non-irritability on baby’s skin and soothes the baby’sskin and hair, also determines the experience of no tears and keeps the baby’sskin moisturized and hydrated after bath, upon application relieving dryness,redness, oedema, urticarial and any other reactions. The proposed benefits areevaluated by the pediatrics, subjective assessment questionnaire andinstrumental evaluation bythe dermatologist/dermatologist trained evaluator and assessment questionnaireat Day 1 and Day 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Day(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •1 Babies in the age group of 0 (including new born full term babies Day 1) to 36 months (inclusive of both genders) at the time of consent 2 Babies general in good health as determined from a recent medical history 3 Babies mother or legal representative preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up 4 Babies mother or legal representative preferably mother willing to abide by and comply with the study protocol 5 Babies should not participate in any other clinical study during participation in the current study.
排除标准
- •1 Subject’s mother or legal caretaker not willing to stop the use of other baby body milk or lotion or cream or any other baby face or body moisturizing product during the study period 2 Chronic illness which may influence the cutaneous state 3 Subject on any systemic medication 4 Subject with birth defects and anomalies 5 Subject participating in a similar clinical study currently or during the previous 30 days 6 Any subject in the Investigators opinion not considered suitable for enrollment 7 A known history or present condition of allergic response to any other concern that may require medical attention 8 Babies with medical history (past present) of significant dermatological diseases or conditions such as atopy psoriasis vitiligo or other conditions known to alter skin appearance or physiologic response (eg.porphyria) chronic urticaria or sunburn rashes.
结局指标
主要结局
1 The safety of the test product will be evaluated on the skin in terms of mildness, gentleness and non-irritability of babies’ skin using pediatrician assessment
时间窗: 1. Day 01 Before application, Day 15 after application | 2. Day 15 after application.
2 To determine the baby experienced no tear, provide quick clean, smooth and gentle effect on baby skin and hair and smooth and shiny hair by subjective self-assessment questionnaire from babies’ mother/ legal caretaker
时间窗: 1. Day 01 Before application, Day 15 after application | 2. Day 15 after application.
次要结局
- 1 The effect of test product will be evaluated on improvement in the skin hydration using Corneometer® CM 825 or Moisture Meter SC(1 Day 01 Before application, Day 15 after application.)