A Single-Center, Four Week Usage Clinical Study to Evaluate the Tolerance and Efficacy of a Whole-Body Balm on Newborn Babies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change From Baseline After 4 Weeks of Product Use in Clinical and Parental Evaluations of Skin tolerance Measures
研究概览
简要总结
The purpose of this study is to evaluate the skin tolerance, instrumental efficacy, and perceived product efficacy of a whole-body balm on newborns (0-28 days old).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn participants only:
- •Male or Female
- •0 to 3 months old, targeting at least 15 subjects in the 0 - 28 days age range at time of enrollment.
- •Has Parent Participant-reported Natural Skin tone/skin Color As Follows, including: (a) Skin tones "Pale/fair to light white" and/or "White to light beige" approximately 10 participants; (b) Skin tones "Beige to light tan/light olive" and/or "Medium tan/medium olive to light brown" approximately 10 participants; (c) Skin tones "Medium brown to dark brown" and/or "Darkest brown to darkest black" approximately 10 participants
- •Full term (37 plus weeks of gestation, both vaginal and Caesarean mode of delivery can be included) newborn
- •Newborn participant and parent participant:
- •Generally, in good health based on medical history reported by the parent participant
- •Parent participant only:
- •Able to read, write, speak, and understand English
- •At least 18 years old and is the parent (adoptive or biological), legal guardian, and primary caregiver of the newborn participant
- •Has signed the informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
- •Intends to complete the study and is willing and able to follow all study instructions
排除标准
- •Newborn participant only:
- •Presents with a skin condition that may influence the outcome of the study or increase risk to the newborn participant (example , psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer)
- •Has a family history of (defined as having a biological parent or full sibling with) eczema/atopic dermatitis
- •Has been bathed within 3 hours prior to Visit 1
- •Has a clinical grade greater than 0 for rash/irritation, or greater than or equal to 1 for any of the other clinically assessed tolerance parameters at Visit 1
- •Newborn participant and parent participant:
- •Has known allergies or adverse reactions to common topical skincare products
- •Has self-reported (for the parent participant) or parent participant reported (for the newborn participant) Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
- •Is taking a medication that would mask an AE or confound the study results, including (a) Immunosuppressive or steroidal drugs within 3 months before Visit 1; (b) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; (C) Antihistamines within 2 weeks (14 days) before Visit 1
研究组 & 干预措施
Whole-body Balm + Wash and Shampoo
Parent participant will be instructed to apply the whole-body balm on the newborn baby's whole body (excluding the mouth, eyes, diaper area, and scalp) two times per day (morning and evening), and to cleanse the newborn baby with the wash and shampoo at least once per week and no more than three times per week up to Day 28.
干预措施: Whole-body Balm (Other)
Whole-body Balm + Wash and Shampoo
Parent participant will be instructed to apply the whole-body balm on the newborn baby's whole body (excluding the mouth, eyes, diaper area, and scalp) two times per day (morning and evening), and to cleanse the newborn baby with the wash and shampoo at least once per week and no more than three times per week up to Day 28.
干预措施: Wash and Shampoo (Other)
结局指标
主要结局
Change From Baseline After 4 Weeks of Product Use in Clinical and Parental Evaluations of Skin tolerance Measures
时间窗: Change from baseline after 4 weeks
Change from baseline after 4 weeks of product use in clinical and parental evaluations of skin tolerance measures will be reported. The clinical and parental evaluations of tolerance will be recorded on paper source documentation.
次要结局
- Change From Baseline After 7 Days of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements(Change from baseline after 7 days)
- Change From Baseline After 7 Days of Product Use in Clinical and Parental Evaluations of Skin Tolerance Measures(Change from baseline after 7 days)
- Percentage of All Response Options for Each Question in the Parental Questionnaire(Day 28)
- Change From Baseline After 4 Weeks of Product Use in Corneometer and Transepidermal Water Loss (TEWL) Measurements(Change from baseline after 4 weeks)
- Number of Response Options for Each Question in the Parental Questionnaire(Day 28)