To evaluate the in-vivo safety and efficacy of skin care formulation in terms of reduction in Dark circles, wrinkles, under eye puffiness and improvement in hydration 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
- Reduction in Dark circles, wrinkles, under eye puffiness and improvement in hydration
研究概览
简要总结
The objective of this study will be to evaluate the in-vivo safety and efficacy of skin care formulation in terms of reduction in Dark circles, wrinkles, under eye puffiness and improvement in hydration on healthy female subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Mexametry, Corneometry, Illustrative Images of the whole face & 3/4th face under diffuse light
The study last 56 days following the first application of the product.
POPULATION: 36 female subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 35 and 55 years, Having mild to moderate dark circles.Having Crows feet wrinkle of grade 2-4 on basis of Skin ageing Atlas. Having visible under eye puffiness.
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
- 35.00 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….)
- •Having mild to moderate dark circles.
- •Having Crows feet wrinkle of grade 2-4 on basis Skin ageing Atlas.
- •Having visible under eye puffiness.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give 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 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 undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
结局指标
主要结局
Reduction in Dark circles, wrinkles, under eye puffiness and improvement in hydration
时间窗: Baseline, Day14, Day28, Day56
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.