To evaluate the in vivo safety and efficacy of a skin care formulations in terms of Skin Brightening, Skin Tone Evenness, and reduction in Acne PIH 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
- 72
- 试验地点
- 1
- 主要终点
- Skin Brightening, Skin Tone Evenness, and reduction in Acne PIH
研究概览
简要总结
OBJECTIVE
The objective of this study will be to evaluate the in vivo safety and efficacy of a skin care formulations in terms of Skin Brightening, Skin Tone Evenness, and reduction in Acne PIH on healthy human subjects.
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Mexametry, Chromametry, Illustrative Images of the whole face & 3/4th face under diffuse light
POPULATION: 72 (36 Male & 36 Female) subjects will be selected for the study.
The subjects selected for this study are healthy male & females, aged between 18 and 35 years old having normal skin type with Dark Spots (Acne PIH) at least 1 spot, dull & uneven skin.
The study will be conducted in 2 groups.
Group A: This group will include 36 (18 male & 18 female) subjects using Product A
Group B: This group will include 36 (18 male & 18 female) subjects using Product B
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
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 2.Having normal skin type with Dark Spots (Acne PIH) at least 1 spot.
- •3.Having uneven skin tone.
- •4.Having dull skin.
排除标准
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give her assent by 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) 5)Having a progressive asthma (either under treatment or last fit in the last 2 years) 6)Being epileptic 7)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8)Having cutaneous hypersensitivity 9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 10) 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) 11)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 13)Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted).
结局指标
主要结局
Skin Brightening, Skin Tone Evenness, and reduction in Acne PIH
时间窗: Baseline, Day 7, Day14, Day28
次要结局
未报告次要终点
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.