To evaluate the in vivo safety and efficacy of a skin care formulation in terms of reduction in hyper pigmentation i.e. Acne PIH, improvement in skin even tone and skin brightness 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 hyperpigmentation
研究概览
简要总结
OBJECTIVE:To evaluate the in-vivo safety and efficacy of a skin care formulation in terms of reduction in hyperpigmentation (Acne PIH), improvement in skin even tone and skin brightness on healthy human subjects
The evaluation will be performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Mexametry, Digital Photographs
POPULATION: 36 (26 Females and 10 male) (30 Completed cases) subjects will be selected for the study.
The subjects selected for this study will be healthy males and females, aged between 18 to 40 years, having normal skin type with visible Acne PIH, at least one 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 Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 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)Subject having Normal skin type.
- •Subject having visible acne PIH with 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.
- •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 hyperpigmentation
时间窗: Baseline, Day 14, Day28
(Acne PIH), improvement in skin even tone and skin brightness
时间窗: Baseline, Day 14, Day28
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.