To evaluate the safety and efficacy of a skin care formulation in terms of skin moisturization, skin water barrier function, skin elasticity, skin plumpness and redness on healthy human subjects
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Skin moisturization, skin water barrier function, skin elasticity, skin plumpness and redness
研究概览
简要总结
OBJECTIVE: The objective of this study will be to evaluate the safety and efficacy of a skin care formulation in terms of skin moisturization, skin water barrier function, skin elasticity, skin plumpness and redness on healthy human subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Corneometry, Tewametry, Mexametry, Cutometry, Digital Photographs
POPULATION: 36 human subjects 26 females and 10 males will be selected for the study.
The subjects selected for this study are healthy human subjects, aged between 18 and 40 years old, having dry skin type.
STUDY DURATION: 28 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 Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian female and male subjects.
- •Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having dry skin type.
排除标准
- •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 and Informed consent form
- •Taking part in another study liable to interfere with this study
- •Being known diabetic case
- •Known asthma case
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Being known thyroid case
- •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 or corticosteroid by any route (the only medication permitted is paracetamol)
- •Known case of hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •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
Skin moisturization, skin water barrier function, skin elasticity, skin plumpness and redness
时间窗: Baseline, 30 Minutes, Day 14, Day28
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.