To evaluate the safety and efficacy of skin care formulation in terms of reduction in pore appearance acne and reduction in sebum on healthy male and 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
- Reduction in pore appearance acne and reduction in sebum
研究概览
简要总结
OBJECTIVE· Primary Objective
The objective of this study is to evaluate the safety and efficacy of skin care formulation in terms of reduction in pore appearance acne and reduction in sebum on healthy male and female subjects.
· Secondary Objective
Secondary objective is to evaluate the in-vivo efficacy of a skin care formulation in terms of Reduction in acne lesion count, Acne Severity Index, acne size & redness on healthy male and female subjects.
The evaluation will be performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Sebumetry, Antera 3D, Digital Photographs
POPULATION36 (18 males & 18 females) will be selected for the study.
The subjects selected for this study will be healthy male & females, aged between 18 and 30 years, having mild to moderate acne, visible pores and oily to mixed oily skin type.
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 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian male & female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit 4.having mild to moderate acne, visible pores and oily to mixed oily skin type.
排除标准
- •1 For female:- Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 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 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Being epileptic.
- •9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10 Having cutaneous hypersensitivity.
- •11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12 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 pore appearance acne and reduction in sebum
时间窗: Baseline, 30 minutes after application, Day 7, Day 14, Day 28
次要结局
- Reduction in acne lesion count, Acne Severity Index, acne size & redness(Baseline, 30 minutes after application, Day 7, Day 14, Day 28)
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.