To evaluate the safety and efficacy of a skin care formulation in terms of anti- aging effect that is improvement in skin firmness, skin moisturisation, reduction in wrinkles and fine lines and reduction in dark spot that is age spot 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 anti-aging effect i.e. improvement in skin firmness, skin moisturisation, reduction in wrinkles and fine lines & reduction in dark spot (age spot) on healthy human subjects.The evaluation will be performed using:Subject Self Evaluation,Dermatological Evaluation: Cosmetic Acceptability,Dermatological Evaluation: Efficacy, Cutometry, Corneometry, Mexametry, Digital Photographs
POPULATION:36 (18 males & 18 females) subjects will be selected for the study.
The subjects selected for this study will be healthy females & males, aged between 35 to 55 years, having crow’s feet wrinkles and dark spot (age spot).
STUDY DURATION : 56 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
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian Male and Female subjects 2)Skin is healthy on the studied anatomic unit 3)Having crows feet wrinkles and dark spot (age spot).
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.