Safety In-Use Study to Assess the Cutaneous Tolerance of Baby Massage Oil 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 on skin in terms of mildness, gentleness and non-irritability of babies’ skin by pediatrician assessment.
研究概览
简要总结
This study is proposed to evaluate and establish the benefits of the test product on mildness, gentleness and non-irritability on baby’s skin and soothes the baby’s skin also determines the baby’s experience of no oily feel, provides quick spreadability, fragrance, gentle effect and keeps the baby’s skin moisturized and hydrated, upon application relieving dryness, redness, oedema, urticaria and any other reactions. The proposed benefits are evaluated by the pediatrics, subjective assessment questionnaire and instrumental evaluation by the dermatologist/dermatologist trained evaluator and assessment questionnaire on Day 01 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
- 0.00 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 of Day 1) to 36 months (inclusive of both genders) at the time of consent.
- •2 APGAR score >7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0-7 days [Refer Appendix III for APGAR scoring].
- •3 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.
- •5 Babies mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
- •6 Babies should not participate in any other clinical study during participation in the current study.
排除标准
- •1 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.
- •2 Chronic illness which may influence the cutaneous state.
- •3 Babies on any systemic medication.
- •4 Babies participating in a similar clinical study, currently or during the previous 30 days.
- •5 Any baby, in the Investigators opinion not considered suitable for enrollment.
- •6 A known history or present condition of allergic response to any other concern that may require medical attention.
- •7 Babies with medical history (past | present) of significant dermatological diseases or conditions, such as atopy, eczema, 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 on skin in terms of mildness, gentleness and non-irritability of babies’ skin by pediatrician assessment.
时间窗: 1.Day 01 before application to Day 15 after application. | 2.Day 01 before application to Day 15 after application.
2.The effect of test product will be evaluated on improvement in the skin hydration using Corneometer® CM 825 and MoistureMeterSC
时间窗: 1.Day 01 before application to Day 15 after application. | 2.Day 01 before application to Day 15 after application.
次要结局
- Baby experienced no oily feel, provide quick spreadability, fragrance and smooth and gentle effect on baby skin by subjective assessment questionnaire(Day 15 after test product application.)