To evaluate the invivo safety & efficacy of lip care formulation in terms of improvement in lip hydration, lip plumping and reduction in lip pigmentation 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
- 主要终点
- Improvement in lip hydration, lip plumping and reduction in lip pigmentation
研究概览
简要总结
| OBJECTIVE- The objective of this study is to evaluate the in-vivo safety & efficacy of lip care formulation in terms of improvement in lip hydration, lip plumping and reduction in lip pigmentation on healthy female subjects |
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Corneometry, Mexametry
The study lasts 28 days following the first application of the product on lips.
POPULATION- 36 (30 completed cases) female subjects will be selected for the study.
The subjects selected for this study are healthy females, aged between 18 and 45 years, having dry lips and pigmentation on the lips..
STUDY DURATION-Duration: 28 days following the first application of the product.
STUDY DESIGN- Single blind study, Non-Comparative study, Subjects 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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 4)Having Dry Lips 5)Having pigmentation on the lips.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give her/his assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
- •Having cutaneous hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
结局指标
主要结局
Improvement in lip hydration, lip plumping and reduction in lip pigmentation
时间窗: Baseline, 3 hours, 6 Hours, 24 Hours, 14 Days, 28 Days
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.