To evaluate and compare the in vivo safety and efficacy of skin care formulations versus Untreated control in terms of the moisturisation and skin water barrier function on healthy female subjects
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- skin moisturisation and skin water barrier function
概览
简要总结
OBJECTIVE:The objective of this study will be to evaluate and compare the in-vivo safety and efficacy of skin care formulations in terms of skin moisturisation and skin water barrier function on healthy female subjects. The evaluation will be performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Corneometry, Tewametry POPULATION: 66 females subjects will be selected for the study. The study will be conducted in 2 groups 33 females subjects in each group Group A: - Product A, Product B & Product C Group B: - Product D, Product E The subjects selected for this study will be healthy females, aged between 18 and 40 years old, having dry skin type. STUDY DURATION: 48 hours following the first application of the products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Indian or Asian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Subject having dry skin type.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
- •Having cutaneous hypersensitivity.
结局指标
主要结局
skin moisturisation and skin water barrier function
时间窗: Baseline, 30 minutes, 24 hours, 48 hours after product application
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.