To evaluate the safety and efficacy of a Skin care formulation in terms of antiaging reduction in fine lines and wrinkles, reduction in pigmentary patches, skin firmness, skin homogeneity and skin moisturisation 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
研究概览
简要总结
OBJECTIVE:The objective of this study will be to evaluate the safety & efficacy of a Skin care formulation in terms of antiaging reduction in fine lines and wrinkles, reduction in pigmentary patches, skin firmness, skin homogeneity and skin moisturisation on healthy human subjects. The evaluation will be performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Cutometry, Spectrophotometry, Corneometry, Mexametry
POPULATION:36 (18 male & 18 female) human subjects will be selected for the study. The subjects selected for this study will be healthy male & females, aged between 25 to 55 years, having crow’s feet, under eye, forehead and nasolabial wrinkles and fine lines, having dull skin, having dark spots and patchy skin.
STUDY DURATION: 84 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
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian male and Female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having crows feet, under eye, forehead and nasolabial wrinkles and fine lines, having dull skin, having dark spots and patchy skin.
排除标准
- •For Females: 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 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 acne prone skin.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 7)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
- •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).
- •Having cutaneous hypersensitivity.
- •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.
- •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).
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.