Safety In-Use Study to Assess the Cutaneous Tolerance of Baby Diaper Rash Cream 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. To evaluate rash skin overall severity scoring scale and Scoring for erythema redness dryness itching & rashes
研究概览
简要总结
The objective of this study is To evaluate the safety of Test product i.e. Baby diaper rash cream inbabies with daily repeated use for 14 consecutive days. 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, also determines the experience of rich creamy feel andkeeps the baby’s skin moisturized and hydrated, upon application relievingdryness, redness, oedema, urticarial and any other reactions. The proposedbenefits are evaluated by the pediatrics, subjective assessment questionnaireand instrumental evaluation by thedermatologist/dermatologist trained evaluator and assessment questionnaire atDay 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
- 1.00 Day(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •1 Babies in the age group of 0 to 36 months inclusive of both genders at the time of consent 2 Babies mother or legal representative preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
- •3 APGAR score greater than 7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0 to 7 days.
- •4 Babies general in good health as determined from a recent medical history.
- •5 Parent or guardian willing to use only the test product in the diaper area during the trial.
- •6 Parent or guardian willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments lotions creams or powders during the trial 7 Parent or guardian is willing to refrain from changing any other products whose use may have an effect on their child skin condition during the trial ie laundry detergents fabric softeners and products used to bathe the child.
- •8 Wear diapers 24 hours per day.
- •9 Present to the test facility for enrollment at baseline with diaper rash receiving an Overall Severity Score greater than or equal to 1.5 as determined by the trained evaluator.
- •10 Babies with mild to moderate rashes on buttocks and or thigh area assessed by Dermatologist or Dermatologist Validated Scorer using scoring scale will be included in the study.
- •12 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 / diaper rash cream or any other baby body moisturizing product during the study period.
- •2.Chronic illness which may influence the cutaneous state.
- •3.Babies on any systemic medication.
- •4.Babies currently being toilet trained.
- •5.Babies participating in a similar clinical study, currently or during the previous 30 days.
- •6.Any baby, 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, 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. To evaluate rash skin overall severity scoring scale and Scoring for erythema redness dryness itching & rashes
时间窗: Day 01 Baseline and Day 15
2. Safety on skin mildness, gentleness and non-irritability of babies’ skin by using Pediatrician Assessment Scoring
时间窗: Day 01 Baseline and Day 15
3. Skin hydration using Corneometer® CM 825 or MoistureMeterSC
时间窗: Day 01 Baseline and Day 15
4. To evaluated on skin barrier function by transepidermal water loss (TEWL) using TEWAmeter® TM 300 or VapoMeter
时间窗: Day 01 Baseline and Day 15
次要结局
- Subjective Assessment Questionnaire from babies’ mother or legal caretaker(Day 15)