To evaluate the in vivo safety and efficacy of skin care formulations in terms of its efficacy to reduce tanning and to improve the skin brightness 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
- 66
- 试验地点
- 1
- 主要终点
- Tan reduction and improvement in skin brightness
研究概览
简要总结
OBJECTIVE:The objective of this study will be to evaluate the in-vivo safety and efficacy of skin care formulations in terms of its efficacy to reduce tanning and to improve the skin brightness on healthy female subjects.The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Chromametry
POPULATION: 66 female subjects will be selected for the study. The study will be conducted in 2 groups, 33 female subjects in each group.Group A: Product A
Group B: Product B
The subjects selected for this study will be healthy subjects, aged between 20 and 35 years old, having Dull and Tanned skin on forearms
STUDY DURATION: 4 days following the first application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 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 4.Having Dull and Tanned skin on forearm.
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.
- •Having undergone a surgery requiring a general anesthetic of more than one hour in the past 6.
结局指标
主要结局
Tan reduction and improvement in skin brightness
时间窗: Baseline, 30 minutes, 1day and 3days after application
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.