The objective of this study will be to evaluate the in vivo safety and efficacy of a skin care formulation in terms of reduction in appearance of cellulite on healthy female
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- VLCC Personal care Ltd.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in appearance of cellulite
概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate the in vivo safety and efficacy of a skin care formulation in terms of reduction in appearance of cellulite on healthy female subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation (Cosmetic Acceptability), Visual Grading of Cellulite
POPULATION: 36 Female subjects are selected for the study.
The subjects selected for this study will be healthy females, aged between 25 and 50 years, having cellulite on the upper arms, belly & thighs visible with the naked eye with a grade higher or equal to 3.
STUDY DURATION: 45 days following the first application of the product.
STUDY DESIGN: Single blind study, Non-comparative study, Subjects do not serve as their own references
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
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian / Asian female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4) Having cellulite on the upper arms, belly and thighs visible with the naked eye.
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)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Being epileptic 8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Having cutaneous hypersensitivity 10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products 11)Following a chronic or intermittent medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 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 appearance of cellulite
时间窗: Baseline, Day 14, Day 28, Day 45
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.