T o evaluate and compare the in vivo efficacy (12 hr. moisturization time claim) and safety of Skin Care Formulation verses Untreated Control in terms of skin moisturization on healthy female subjects
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Panacea Biotec Pharma Ltd.
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- skin
概览
简要总结
OBJECTIVE
The objective of this study will be to evaluate and compare the in vivo efficacy and safety of Skin Care Formulation verses Untreated Control in terms of skin moisturization on healthy female subjects for product.
Test Product: Baby Massage Oil: Product A
Baby Lotion: Product B
Techniques: The evaluation is performed using: 1) Subject Self Evaluation, 2) Dermatological Evaluation: Safety and 3) Corneometry
Total duration of the study: 12 hours following the first application of the product.
Kinetics: T0, T+30 Minutes after product application, T+6 Hours after product application, T+8 Hours after product application & T+12 Hours after product application
POPULATION: 33 female subjects will be selected for the study.
The subjects selected for this study are healthy female subject, aged between 18 and 40 years old, having dry skin on forearms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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 female subjects 2)Healthy subjects 3) Skin is healthy on the studied anatomic unit 4) Subject having dry skin on forearms.
排除标准
- •Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give 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.
结局指标
主要结局
skin
时间窗: T0, 30 Minutes | after product application, 6 Hours after product application, 8 Hours after product application | & 12 Hours after product application
moisturization
时间窗: T0, 30 Minutes | after product application, 6 Hours after product application, 8 Hours after product application | & 12 Hours after product application
次要结局
未报告次要终点
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.