Safety In-Use Study to Assess the Cutaneous Tolerance of Baby Soap in Healthy Babies of 0 to 36 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1.The safety of the test product will be evaluated the on skin in terms of mildness, gentleness and non-irritability of babies’ skin by pediatrician assessment change from baseline.
研究概览
简要总结
This study is proposed to evaluate and establish the benefits of thetest product on mildness, gentleness and non-irritability on baby’s skin andsoothes the baby’s skin and hair, also determines the experience of no tearsand keeps the baby’s skin moisturized and hydrated after bath, upon applicationrelieving dryness, redness, oedema, urticarThis study is proposed to evaluate and establish the benefits of thetest product on mildness, gentleness and non-irritability on baby’s skin andsoothes the baby’s skin and hair, also determines the experience of no tearsand keeps the baby’s skin moisturized and hydrated after bath, upon applicationrelieving dryness, redness, oedema, urticarial and any other reactions. Theproposed benefits are evaluated by the paediatrics, subjective assessmentquestionnaire and instrumental evaluation by the dermatologist/dermatologisttrained evaluator and assessment questionnaire at Day 1 and Day15.ial and any other reactions. Theproposed benefits are evaluated by the paediatrics, subjective assessmentquestionnaire and instrumental evaluation by the dermatologist/dermatologisttrained evaluator and assessment questionnaire at Day 1 and Day15.
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 Day(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Babies in the age group of 0 (including new born full term babies of Day 1) to 36 months (inclusive of both genders) at the time of consent.
- •APGAR score >7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0-7 days.
- •Babies general in good health as determined from a recent medical history 4)Babies mother/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
- •Babies mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
- •Babies should not participate in any other clinical study during participation in the current study.
排除标准
- •Babies’ mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / massage oil or any other baby face/body moisturizing product during the study period.
- •Chronic illness which may influence the cutaneous state as per Investigator.
- •Babies on any systemic medication.
- •Babies participating in a similar clinical study, currently or during the previous 30 days.
- •Any baby, in the Investigators opinion not considered suitable for enrollment.
- •A known history or present condition of allergic response to any other concern that may require medical attention.
- •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 (e.g. porphyria) chronic urticaria, or sunburn, rashes.
结局指标
主要结局
1.The safety of the test product will be evaluated the on skin in terms of mildness, gentleness and non-irritability of babies’ skin by pediatrician assessment change from baseline.
时间窗: 1.Day 01 before application to Day 15 after application. | 2.Day 15 after test product application.
2.To determine the baby experienced no tear, provide quick clean, smooth and gentle effect on baby skin and hair by subjective assessment questionnaire from babies’ mother/ legal caretaker after test product application on Day 15.
时间窗: 1.Day 01 before application to Day 15 after application. | 2.Day 15 after test product 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 MoistureMeter SC change from baseline.(1.Day 01 before application to Day 15 after application.)