To evaluate the in vivo safety and efficacy of a skin care formulation in terms of Skin Brightening, Skin Smoothness, Skin Softness, Skin Glow and Skin Hydration on healthy human subjects
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ClayCo. Cosmetics Pvt. Ltd.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Skin Brightening, Skin Smoothness, Skin Softness, Skin Glow and Skin Hydration
概览
简要总结
OBJECTIVEThe objective of this study will be to evaluate the in-vivo safety and efficacy of a skin care formulation in terms of Skin Brightening, Skin Smoothness, Skin Softness, Skin Glow and Skin Hydration on healthy human subjects.
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Corneometry
POPULATION :36 (18 females and 18 male) subjects will be selected for the study. The subjects selected for this study will be healthy males and females, aged between 18 and 45 years old, having wheatish to dark complexion and dry skin.
STUDY DURATION
28 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
- •Indian male & female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having wheatish to dark complexion.
- •Having dry skin.
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 and Informed consent form
- •Taking part in another study liable to interfere with this study
- •Being known diabetic case
- •Known asthma case
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Being known thyroid case
- •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 or corticosteroid by any route (the only medication permitted is paracetamol)
- •Known case of hypersensitivity.
结局指标
主要结局
Skin Brightening, Skin Smoothness, Skin Softness, Skin Glow and Skin Hydration
时间窗: Baseline, Day 7, Day 14 and Day28
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.