To evaluate the in vivo safety and efficacy of a skin care formulation in terms of non comedogenic and mattifying effect and sebum reduction 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
研究概览
简要总结
OBJECTIVE :The objective of this study will be to evaluate the safety and efficacy of the skin care formulation in terms of non-comedogenic & mattifying effect & sebum reduction on healthy female subjectscoded:The evaluation will be performed using:Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability , Dermatological Evaluation: Efficacy, Sebumetery, Glossymetry, Digital Photographs
POPULATION : 36 Female subjects will be selected for the study. The subjects selected for this study will be healthy females, aged between 18 and 35 years, presenting oily & mixed oily skin on the face
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 35.00 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 oily & mixed oily skin on the face.
排除标准
- •1 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.
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.
