To evaluate and compare the in-vivo safety and efficacy of three skin care formulations versus Untreated control in terms of the moisturization effect on healthy human subjects.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Improvement in skin Moisturization
概览
简要总结
OBJECTIVE
The objective of this study will be to evaluate and compare the in-vivo safety and efficacy of three Skin Care Formulations versus Untreated control in terms of the Moisturizing Effect on healthy human subjects
The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Corneometry
POPULATION: 33 (16/17 females & 17/16 males) subjects are selected for this study.
The subjects selected for this study are healthy females and males aged between 18 and 65 years, having dry skin on forearms.
STUDY DURATION: 72 Hours following the application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 2)Subject having dry skin on forearms.
排除标准
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.Having refused to give her assent by signing the consent form.
- •Taking part in another study liable to interfere with this study.
- •Being known diabetic case 4)Known asthma case 5)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 6)Being known thyroid case 7)Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following product: aspirin-based product, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol) 9)Known case of hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic product.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed their cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
- •Having applied a cosmetic product (included make-up) on the studied areas 48 hours prior study.
结局指标
主要结局
Improvement in skin Moisturization
时间窗: Baseline, 30 minutes, 48 hours and 72 hours
次要结局
未报告次要终点
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.