To evaluate the safety and efficacy of a skin care formulation in terms of skin firmness, elasticity, hydration,brightness, skin shine glow and reduction in pore size on healthy human 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
- Skin firmness, elasticity, hydration, brightness, skin shine/glow and reduction in
研究概览
简要总结
OBJECTIVE-The objective of this study will be to evaluate the safety (acceptability) and efficacy of a skin care formulation in terms of skin firmness, elasticity, hydration, brightness, skin shine/glow and reduction in pore size on healthy human subjects for product
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Corneometry, Glossymeter, Chromametry, Skin pH metry, Cutometry, VisioFace (Images Analysis for Pore size through cross polarized light)
The study duration is for 28 days (+ 1 day) following the first application of the product on the whole
face.
POPULATION- 36 (18 male and 18 female) healthy subjects will be included for the study.
They will be aged between 18 and 45 years (both inclusive) of varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination (dry or normal in some areas and oily in others) and having visible pores on face as evaluated by the dermatologist.
STUDY DESIGN- This is a single arm study, Non-Comparative study, Subjects will serve as their own references.
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian / Asian male and female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 4)Having varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination) 5)Having visible pores on face as determined by the dermatologist.
排除标准
- •For females: 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 3)Taking part in another study liable to interfere with this study 4)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Being epileptic.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
- •Under 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 undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •Having applied a cosmetic product (included make-up) on the studied areas during study evaluations.
结局指标
主要结局
Skin firmness, elasticity, hydration, brightness, skin shine/glow and reduction in
时间窗: Baseline, Immediate after product application, 2 hours, 14 days, 28 days
pore size
时间窗: Baseline, Immediate after product application, 2 hours, 14 days, 28 days
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.