To evaluate safety and efficacy of skin care formulation in terms of reduction in under eye wrinkles and fine lines and reduction in crows feet wrinkles and fine lines 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 under eye wrinkles & fine lines and reduction in crows feet wrinkles & fine lines
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate the safety & efficacy of a skin care formulation in terms of reduction in under eye wrinkles & fine lines and reduction in crows feet wrinkles & fine lines on healthy human subjects. The evaluation will be performed using:Subject Self Evaluation,Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy
POPULATION:36 (18 female & 18 male) subjects will be selected for the study. The subjects selected for this study will be healthy females, aged between 35 to 55 years, having under eye wrinkles & fine lines and crow’s feet wrinkles & fine lines.
STUDY DURATION 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
- 35.00 Year(s) 至 55.00 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 under eye wrinkles & fine lines and crows feet wrinkles & fine lines.
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.
- •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 under eye wrinkles & fine lines and reduction in crows feet wrinkles & fine lines
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.