To evaluate & compare the in-vivo safety and efficacy of a skin care formulation versus placebo in terms of reduction in fine lines and wrinkles, reduction in dark spots, skin firmness, skin brightness, skin water barrier function and skin moisturization 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
- Reduction in fine lines and wrinkles, reduction in dark spots (age spots), skin firmness, skin brightness, skin water barrier function and skin moisturization
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate & compare the in-vivo safety and efficacy of a skin care formulation versus placebo in terms of reduction in fine lines and wrinkles, reduction in dark spots (age spots), skin firmness, skin brightness, skin water barrier function and skin moisturization on healthy female subjects
The evaluation is performed using:Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Corneometry, Tewametry, Cutometry, Mexametry
The study will last 84 days be following the first application of the product.
POPULATION: 36 subjects will be selected for the study. These subjects will be divided into 2 groups of 18 female subjects each.
Group A: This group will include 18 female subjects using test Product A
Group B: This group will include 18 female subjects using test Product B
The subjects selected for this study are healthy females aged between 35-55 years of age having crow’s feet wrinkles & fine lines and dark spots (age spot), at least 1 dark spot of 3mm or more on face.
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
- •1.Indian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4.Subject having Crows feet wrinkle 5.Subject having dark spots.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his 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)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Being epileptic.
- •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 cutaneous hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
结局指标
主要结局
Reduction in fine lines and wrinkles, reduction in dark spots (age spots), skin firmness, skin brightness, skin water barrier function and skin moisturization
时间窗: Baseline, Day14, Day28, Day56, day84
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.