An Open Label, Single Arm Clinical Study to Evaluate Safety, In-Use Tolerability and Efficacy of a Diaper Rash Cream in Healthy Babies of 6 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
- Assessment of severity of rashes by a Pediatrician using overall severity scoring scale
研究概览
简要总结
This is an open label, non-randomized, single-arm, clinical study to evaluate safety, in-use tolerability and efficacy of Diaper Rash Cream in healthy babies with diaper rash.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written parental informed consent from Baby’s mother/legal caretaker.
All eligible subjects will undergo clinical evaluation by a Dermatologist, instrument evaluation and feedback from baby’s mother/legal caretaker. Safety will be assessed throughout the study by monitoring adverse events and local intolerances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Babies who are generally in good health as determined from a recent medical history and the pediatrician.
- •Babies having an "Overall Severity Score" greater than or equal to 1.5 as determined by the trained evaluator.
- •Babies who wear diapers for at least 12 hours per day.
- •Babies delivered after complete gestation (more than 38 weeks).
排除标准
- •Babies mother/legal caretaker not willing to stop the use of other baby products other than the provided test product on the affected area during the study period.
- •Babies with chronic illness / systemic illness which may influence the cutaneous state.
- •Babies on any systemic medication / undergoing treatment for skin disorders.
- •Babies with diarrhea/ bowel incontinence.
- •Babies who are currently being toilet trained.
结局指标
主要结局
Assessment of severity of rashes by a Pediatrician using overall severity scoring scale
时间窗: Day 01 (before application), Day 02 (i.e., 24 hours (+ 2 hours) post application), Day 07 and Day 14
次要结局
- Assessment of product’s mildness and gentleness on baby’s skin by a Pediatrician using 5-point grading scale(Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application, Day 07, Day 14)
- Assessment of skin barrier function using TEWAmeter® TM300/Vapometer(Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14)
- Assessment of erythema of the affected area using Mexameter® MX 18(Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14)
- Product Perception by taking feedback(Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14)
研究者
Dr Devang Gokalani
Shreeji Hospital