A Clinical Study in Infants to Assess the Tolerability of Three Wash Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Tolerability Assessment of Test Products
研究概览
简要总结
This will be a single centre, evaluator blind, randomized, parallel group, stratified, two week study in healthy participants. The clinical study is designed to provide reassurance that the formulations developed for children and babies with mild to moderately dry skin and for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the target population, babies and young children with dry skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants up to 18 months of age at the screening/baseline visit with good general health and no major physical disabilities
- •Parent/legal guardian reported dry skin
- •Voluntary written informed consent form by parent/legal guardian as an evidence to understanding of the study and willingness to participate
排除标准
- •Allergy/intolerance or hypersensitivity to the study material or any of their stated ingredients
- •Participant with skin condition that warrants medical intervention, current episode of eczema/atopic dermatitis or has had an episode in the 3 months prior to screening, not regular use of moisturizers (variable application frequency)
- •Use of oral corticosteroids/immunosuppressive medication within 4 weeks or topical corticosteroids/topical anti-itch products within 2 weeks of baseline
- •Child in Care; participants' previous participation in this study/another clinical study/receipt of investigational drug within 30 days of the screening visit
- •Parent/legal guardian aged 18 years or under, employee of the sponsor or the study site or members of their immediate family
- •Participant living in the same household of an already enrolled participant
研究组 & 干预措施
Test shampoo
Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
干预措施: Test shampoo (Other)
Test bath foam
Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
干预措施: Test bath foam (Other)
Test head to toe Wash
Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks.
干预措施: Test head to toe wash (Other)
结局指标
主要结局
Tolerability Assessment of Test Products
时间窗: At Day 14
The tolerability of the test products under normal conditions of use was assessed by the paediatrician using a 5 point scale: where score 1= very good; 2= good; 3= acceptable; 4= poor and 5= very poor.
次要结局
- Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)(At baseline and day 14)