An Open-Label, Single-Centre, Prospective, Interventional, Clinical Study to Evaluate the Safety, Efficacy and In-Use Tolerability Study of TediBar Ceramax Bathing Bar in Infants and Toddlers aged 0-36 months.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. To evaluate the efficacy of the test product by assessing change in skin hydration from baseline before usage and post usage of test product.
研究概览
简要总结
This is an open-label, single-centre, prospective, single-arm clinical study designed to evaluate the safety, efficacy, and in-use tolerability of the Tedibar Ceramax bathing bar in infants and toddlers aged 0 to 36 months.
A total of 30 participants—including infants and toddlers with dry and sensitive skin—will be enrolled. The age group includes participants from birth (0 months) up to 36 months, with at least 1–2 infants aged 0 months. Infants aged 0 months will be excluded from instrumental assessments such as Corneometer® CM 825 and TEWAMeter® TM Hex evaluations.
Screening of potential participants will be performed based on the study’s inclusion and exclusion criteria, only after obtaining written informed consent from the parent(s) or legal guardian(s). Prior to the enrolment visit, parent(s)/legal guardian(s) will be contacted telephonically by the recruiting department.
The study includes two scheduled visits over a period of 15 days (±2 days) from the date of enrolment:
· Visit 01 (Day 01): Screening, enrolment, and informed consent documentation
· Visit 02 (Day 15 ± 2 Days): Post-product application assessments and end-of-study procedures
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
- 0.00 Month(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Overall Good health of the baby is determined by medical examination and history evaluated by Investigator.
- •The subject may be of either sex, aged 0–36 months at the time of parental consent, and must have been of normal birth weight as determined by the physician.
- •Overall healthy baby as per the Paediatrician.
- •Babies with dry and sensitive skin as determined by the paediatrician will be enrolled in the study.
- •Baby is in a healthy condition having exclusively breast-fed up to the age of 6 months.
- •Babies’ parent/legal guardian, preferably willing to give a voluntary written informed consent i.e. parental informed consent and agree to complete study activities and come for regular follow-up with a subject.
- •Medically stable babies without any requirement of drugs interventions, procedures, nutraceutical or other health supplement
- •The babies’ parent/legal guardian for their child is preferably willing to abide by and comply with the study protocol.
- •The babies should not participate in any other clinical study during participation in the current study.
排除标准
- •Babies with known history of allergies to any of the components (Ceramides and Hyaluronic acid) of Tedibar Bathing Bar.
- •Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterial or antifungals within one week prior to baseline visit.
- •Babies who would not be considered suitable for topical therapy.
- •History of sensitivity to the study product, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator
- •Babies who have a known history or present allergic condition that may require medical attention.
- •Babies’ who have Chronic illness which may influence the cutaneous assessment
- •Babies not willing to stop the use of other soaps during study period.
- •Babies has participated in a similar clinical investigation in the past four weeks.
结局指标
主要结局
1. To evaluate the efficacy of the test product by assessing change in skin hydration from baseline before usage and post usage of test product.
时间窗: To evaluate the effectiveness of test product by assessing change in skin hydration evaluated through Corneometer® CM 825 from baseline on Day 01 and Day 15. | To evaluate the effectiveness of test product by assessing change in skin barrier function evaluated through TEWAMeter® TM Hex from baseline on Day 01 and Day 15 | To evaluate the effectiveness of test product by assessing change in skin pH evaluated through pH meter from baseline on Day 01 and 15.
2. To evaluate the efficacy of the test product by assessing change in skin barrier function from baseline before usage and post usage of test product.
时间窗: To evaluate the effectiveness of test product by assessing change in skin hydration evaluated through Corneometer® CM 825 from baseline on Day 01 and Day 15. | To evaluate the effectiveness of test product by assessing change in skin barrier function evaluated through TEWAMeter® TM Hex from baseline on Day 01 and Day 15 | To evaluate the effectiveness of test product by assessing change in skin pH evaluated through pH meter from baseline on Day 01 and 15.
3. To evaluate the efficacy of the test product by assessing change in pH balance from baseline before usage and post usage of test product.
时间窗: To evaluate the effectiveness of test product by assessing change in skin hydration evaluated through Corneometer® CM 825 from baseline on Day 01 and Day 15. | To evaluate the effectiveness of test product by assessing change in skin barrier function evaluated through TEWAMeter® TM Hex from baseline on Day 01 and Day 15 | To evaluate the effectiveness of test product by assessing change in skin pH evaluated through pH meter from baseline on Day 01 and 15.
次要结局
- 1. To evaluate the efficacy of the test product by assessing change in skin dryness from baseline before usage and post usage of test product.(1. To evaluate the effectiveness of test product by assessing change in skin dryness through Overall Dry Score (ODS) evaluated by paediatrician trained evaluator and paediatrician from baseline on Day 01 (prior to product usage) and post usage assessments on Day 15 (±2 Days).)
- 2. To evaluate the efficacy of the test product by assessing change in skin mildness, irritation and dryness from baseline before usage and post usage of test product.(2. To evaluate the effectiveness of test product by assessing change in skin mildness, irritation and dryness evaluated through Investigator assessment scale from baseline on Day 01 (prior to product usage) and post usage assessments on Day 15 (±2 Days).)
- 3. To evaluate the efficacy of the test product by assessing change in Mother’s Feedback questionnaire from baseline before usage and post usage of test product.(3. To evaluate the effectiveness of test product by assessing change in Mother’s Feedback questionnaire evaluated 5-point Likert scale in terms of no more tears, mild and soothing fragrance, mild and gentle on baby’s skin from baseline on Day 01 (prior to product usage) and post usage assessments on Day 15 (±2 Days).)
研究者
Dr Vipul Shah MD Paediatrician
NovoBliss Research Private Limited