To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of reduction in acne reduction in pore size, reduction in skin sebum content & improvement in 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 acne reduction in pore size, reduction in skin sebum content & improvement in skin brightness
研究概览
简要总结
OBJECTIVE - The objective of this study is to evaluate the in-vivo safety and efficacy of the skin care formulation in terms of reduction in acne reduction in pore size, reduction in skin sebum content & improvement in skin brightness on healthy human subjects
POPULATION - 36 (18 males + 18 females) subjects are selected for the study.
The subjects selected for this study are healthy males & females, aged between 18 and 30 years, having mild to moderate acne and oily to mixed oily skin type and visible pores.
DURATION - 14 days following the first application of the product
STUDY DESIGN - Single blind study.
The evaluation is performed using- 1) Subject’s Self Evaluation, 2)Dermatological Evaluation: Safety 3)Dermatological Evaluation: Efficacy 4) Sebumetry 5)Illustrative photographs of whole face & ¾ th face under diffused light
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 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Skin is healthy on the studied anatomic unit 2)Having mild to moderate acne 3)Having mixed oily or oily skin on the face.
- •Having visible pores.
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.
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 4)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
Reduction in acne reduction in pore size, reduction in skin sebum content & improvement in skin brightness
时间窗: Baseline, Day 3, Day 7, Day 14
次要结局
未报告次要终点
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.