To evaluate the invivo efficacy and safety of a skin care formulation in terms of reduction in wrinkles and fine lines, density of dark spots, improvement in skin smoothness, plumpness, skin even tone, skin moisturization, trans epidermal water loss, skin brightening, skin firmness and skin elasticity 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, density of dark spots, improvement in skin smoothness, plumpness, skin even tone, skin moisturization, trans epidermal water loss, skin brightening, skin firmness & skin elasticity on healthy female subjects.
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Corneometry, Tewametry, Mexametry, Cutometry, Illustrative Images of the whole face & 3/4th face under diffuse light
The study lasts for 28 days following the first application of the product.
POPULATION: 33 female subjects will be selected for the study.
The subjects selected for this study will be healthy females aged between 30 to 60 years, having crow’s feet wrinkles & fine lines, dark spots (age spot) & 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
- •Healthy subjects
- •Skin is healthy on the studied anatomic
- •Having Crows feet wrinkle
- •Having at least 1 dark spot (age spot).
- •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, density of dark spots, improvement in skin smoothness, plumpness, skin even tone, skin
时间窗: Baseline, Day 14, Day 28
moisturization, trans epidermal water loss, skin brightening, skin firmness & skin elasticity
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.