To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in wrinkles & fine lines, improvement in smoothness, skin even tone, skin moisturisation, skin firmness, elasticity, Trans Epidermal Water loss & skin Luminosity 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 wrinkles
研究概览
简要总结
OBJECTIVE: To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in wrinkles & fine lines, improvement in smoothness, skin even tone, skin moisturisation, skin firmness, elasticity, Trans Epidermal Water loss & skin Luminosity on healthy female subjects.
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Corneometry, Tewametry, Cutometry, Chromametry, Expert Evaluation, Illustrative Images of whole face & ¾ th face under diffused light
The study lasts 28 days following the first application of the test product on the whole face.
POPULATION: 33 female subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 30 and 60 years old, having crow’s feet wrinkles & having varied skin type & sensitive skin type with 1:1 ratio
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 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects
- •Healthy subjects
- •Skin is healthy on the studied anatomic unit
- •Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas.
- •Having varied skin type & sensitive skin type.
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 non stabilized thyroid problems (requirement of a stabilized treatment for at least 6
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic
- •products or food products.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes(the only medication permitted is paracetamol).
- •Having cutaneous hypersensitivity.
- •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 wrinkles
时间窗: Baseline, Day 14, Day 28
& fine lines, improvement in smoothness, skin even tone, skin moisturisation, skin firmness, elasticity, Trans Epidermal Water loss & skin Luminosity
时间窗: Baseline, Day 14, Day 28
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.