To evaluate the in vivo efficacy and safety of a skin care formulation in terms of skin brightening, skin radiance and glow, skin hydration, skin water barrier function and tan reduction 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
- 30
- 试验地点
- 1
- 主要终点
- Skin brightening, skin radiance, glow, skin hydration, skin water barrier function and tan reduction
研究概览
简要总结
PRIMARY OBJECTIVE: To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of skin brightening, skin radiance & glow, skin hydration, skin water barrier function and tan reduction on healthy human subjects.
SECONDARY OBJECTIVE: To evaluate the in-vivo efficacy and safety of skin care formulation in terms of skin firmness & skin elasticity on healthy human subjects.
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Corneometry, Tewametry, Cutometry, CLBT (Color, Luminosity, Brightness, Transparency), Illustrative Images of whole face & ¾ th face under Diffused Light
POPULATION: 36 (18 male & 18 female) subjects will be selected for the study.
The subjects selected for this study are healthy males & females, aged between 18 and 35 years old, wheatish to dark complexion with mixed inclusion of dry, oily and combination skin types & having dull tan skin.
Duration: 56 days following the first application of the test product
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian male and female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Saving wheatish to dark complexion 5)Having dry, oily and combination skin type.
- •Having dull tan skin.
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 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.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •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
Skin brightening, skin radiance, glow, skin hydration, skin water barrier function and tan reduction
时间窗: Baseline, Day 7, Day 14, Day 28, Day 56
次要结局
- Skin firmness & skin elasticity(Baseline, Day 7, Day 14, Day 28, Day 56)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.