To evaluate and compare the in vivo safety and efficacy of skin care formulations versus Untreated control in terms of the skin moisturization on healthy female subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Skin moisturisation
研究概览
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 on healthy female subjects.The evaluation will be performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Corneometry
POPULATION: 66 (males and females) subjects will be selected for the study. The study will be conducted in 2 groups 33 males and females subjects in each group (16 males and 17 females or 16 females and 17 males)
Group A: - Product A, Product B & Product C
Group B: - Product D, Product E
The subjects selected for this study will be healthy females & males, aged between 18 and 40 years old, having dry skin type.
STUDY DURATION: 48 hours following the first application of the product.
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
- All
入选标准
- •1.Indian Males and female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Subject having dry skin type.
排除标准
- •For females: 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.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
结局指标
主要结局
Skin moisturisation
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.