To evaluate the in vivo dermatological safety and anti ageing efficacy of a skin care formulation in terms of reduction in fine lines and wrinkles, improvement in skin brightness, skin firmness 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, improvement in skin brightness, skin firmness & skin moisturization
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate the in-vivo dermatological safety and anti-ageing efficacy of a skin care formulation in terms of reduction in fine lines and wrinkles, improvement in skin brightness, skin firmness & skin moisturization on healthy human subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Cutometry, Corneometry, Digital Photographs
POPULATION: 36 (26 Female+ 10 male) subjects will be selected for the study.
The subjects selected for this study are healthy females aged between 35 and 55 years, having crows feet wrinkles.
STUDY DURATION`:42 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
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian female and male subjects.
- •Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having crows feet wrinkles.
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
Reduction in fine lines and wrinkles, improvement in skin brightness, skin firmness & skin moisturization
时间窗: Baseline, Day 14, Day28, Day 42
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.