To evaluate the in vivo efficacy and safety of a breast line firming formulation in terms of improvement in breast firmness, breast shape & breast upliftment 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
- 30
- 试验地点
- 1
- 主要终点
- Improvement in breast firmness, breast shape & breast upliftment
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluatethe in- vivo efficacy and safety of a breast line firming formulation in termsof improvement in breast firmness, breast shape & breast upliftment onhealthy female subjects.
The evaluation is performed using: Subject Self Evaluation, DermatologicalEvaluation: Cosmetic Acceptability, Expert assessment, Anthropometricmeasurements, Cutometry
POPULATION: 36 Female subjects will be selected for thestudy.
The subjects selected for this study will be healthyfemales, aged between 18-40 years, complaining flaccid breast, withBMI-25-35kg/m2.
STUDY DURATION: 56days following the application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 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) Volunteers complaining flaccid breast.
- •Body Mass Index- 25-35 kg/m2.
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 breast firmness, breast shape & breast upliftment
时间窗: Baseline, Day 28, Day 56
次要结局
未报告次要终点