To evaluate the in-vivo efficacy and safety of a skin care regime in terms of improvement in Skin Firmness, skin elasticity, Skin Moisturization, and skin water barrier function 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
- 36
- 试验地点
- 1
- 主要终点
- Improvement in Skin Firmness, skin elasticity, Skin Moisturization, and skin water barrier function
研究概览
简要总结
To evaluate the in-vivo efficacy and safety of a skin care regime in terms of improvement in Skin Firmness, skin elasticity, Skin Moisturization, and skin water barrier function on healthy female subjects
The evaluation will be performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Corneometry, Cutometry, Tewametry, Illustrative Images of the whole face under diffuse light
The study lasts for 15 days following the first application of the product.
POPULATION: 36 Female Subjects will be selected for the study.
The subjects selected for this study will be healthy females, aged between 30 to 55 years, having loose skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects.
- •Healthy subjects
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
- •Subjects having loose skin.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give his/her 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)
- •Being epileptic
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having cutaneous hypersensitivity
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
- •Following a chronic or intermittent medicinal treatment comprising any of the following products:aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 12.
结局指标
主要结局
Improvement in Skin Firmness, skin elasticity, Skin Moisturization, and skin water barrier function
时间窗: Baseline, 30 minutes after product application, Day 7, Day 15
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.