To evaluate and compare the invivo safty and efficacy of skin care formulation verses untreated control in terms of skin moisturization and skin barrier function on healthy female subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Skin moisturization and skin barrier function
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 Formulation verses Untreated Control in terms of skin moisturization and skin barrier function on healthy female subjects.
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Corneometry, Tewametry.
The study lasts 4 days following the first application of the product on the forearm.
POPULATION- 33 Female subjects will be selected for the study .
The subjects selected for this study are healthy female, aged between 18 and 40 years old, having dry skin type.
STUDY DURATION-Duration: 72 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 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
- •Indian / Asian female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 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.
- •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 moisturization and skin barrier function
时间窗: Baseline, 15 Minutes, 30 Minutes, 24 Hours, 48 Hours, 72 Hours
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.