To evaluate the in vivo safety and efficacy of a skin care formulation in terms reduction in hyperpigmentation that is age spots and skin even tone on healthy female subjects
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AU Naturel Beauty Pvt. Ltd (NEUDE).
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction hyperpigmentation (age spots) and skin even tone
概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate the in vivo safety and efficacy of a skin care formulation in terms reduction hyperpigmentation (age spots) and skin even tone on healthy female subjects coded:
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy , Chromametry, Mexametry
The study lasts for 56 days following the first application of the product.
POPULATION: 36 females subjects are selected for the study.
The subjects selected for this study are healthy females aged between 30 and 55 years***,*** having**age spots, at least one spot of 3mm or more.
S****TUDY DURATION: 56 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
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy subjects 2)Skin is healthy on the studied anatomic unit 3)Having age spots, at least one spot of 3mm or more.
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.
结局指标
主要结局
Reduction hyperpigmentation (age spots) and skin even tone
时间窗: Baseline, Day28. Day 56
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.