To evaluate the in vivo dermatological safety and efficacy of a skin care formulation in terms of improvement in skin moisturisation, skin even tone and skin brightness, and reduction in dark spots i.e. Acne PIH on healthy female 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
- Improvement in skin moisturisation, skin even tone & skin brightness and reduction in dark spots (Acne PIH)
研究概览
简要总结
PRIMARY OBJECTIVE :The objective of this study will be to evaluate the in-vivo dermatological safety and efficacy of a skin care formulation in terms of improvement in skin moisturisation, skin even tone & skin brightness and reduction in dark spots (Acne PIH) on healthy female subjects.
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Chromametry , Corneometry, Mexametry, Digital Photographs
POPULATION : 36 female subjects will be selected for the study.
The subjects selected for this study are healthy males aged between 18 and 40 years, having normal skin type with visible Acne PIH spots, at least one acne spot of 3mm or more.
STUDY 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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Indian female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.Having normal skin type with visible Acne PIH.spots, at least one acne 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 her/his 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 a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •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 (the only medication permitted is paracetamol)
- •Having cutaneous hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
结局指标
主要结局
Improvement in skin moisturisation, skin even tone & skin brightness and reduction in dark spots (Acne PIH)
时间窗: Baseline, 30 minutes, 14 days, 28 days
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.