To evaluate the in-vivo efficacy and safety of a skin care regime in terms of reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, skin hydration, skin gloss & skin elasticity on healthy females subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, skin hydration, skin gloss & skin elasticity
研究概览
简要总结
OBJECTIVE: To evaluate the in-vivo efficacy and safety of a skin care regime in terms of reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, skin hydration, skin gloss & skin elasticity on healthy females subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Safety, Mexametry, Chromametry, Corneometry, Glossymeter, Cutometry
POPULATION:72 (36 for test regime and 36 for placebo) female subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 18 and 40 years old, having normal skin type with visible Acne PIH.
STUDY DURATION: 28 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 Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects.
- •Healthy subjects.
- •Skin is healthy on the studied anatomic unit 4)Having normal skin type with visible Acne PIH.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give her assent by not signing the consent form.
- •Taking part in another study liable to interfere with this study.
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having progressive asthma.
- •Being epileptic.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having cutaneous hypersensitivity
- •Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
- •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 (the only medication permitted is paracetamol)
- •Having consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
- •Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted).
结局指标
主要结局
Reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, skin hydration, skin gloss & skin elasticity
时间窗: Baseline, Day 7, Day 14, Day 28
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.