To evaluate the in vivo efficacy of a skin care formulation in terms of Tan Reduction, skin brightening, even tone, hydration, skin barrier, softness and smoothness on healthy 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
研究概览
简要总结
OBJECTIVE :The objective of this study will be to evaluate the in vivo efficacy of a skin care formulation in terms of Tan Reduction, skin brightening, even tone, hydration, skin barrier, softness and smoothness on healthy subjects coded:
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy , Spectrophotometry, Corneometry, Tewametry, Mexametry, Digital Photographs
POPULATION :36 (25male & 11female) subjects will be selected for the study.
The subjects selected for this study will be healthy females, aged between 18 and 45 years, having wheatish, tanned skin.
STUDY DURATION : 21 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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian male and female subjects.
- •2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Having wheatish, tanned skin.
排除标准
- •1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5 Having a progressive asthma (either under treatment or last fit in the last 2 years) 6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Being epileptic.
- •9 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) 10 Having cutaneous hypersensitivity.
- •11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.