To evaluate and compare the safety and efficacy of skin care formulation in terms of moisturization and Skin Barrier Function (trans epidermal water loss) versus untreated control on healthy human subjects
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- SATIYA NUTRACEUTICALS PRIVATE LIMITED
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Moisturization and Skin Barrier Function (trans epidermal water loss)
概览
简要总结
OBJECTIVE
The objective of this study will be to evaluate and compare the safety and efficacy of skin care formulation in terms of moisturization and Skin Barrier Function (trans epidermal water loss) versus untreted control on healthy human subjects for product coded:
The evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Corneometry, Tewametry
POPULATION: 33 (17/16 females & 16/17 males) subjects will be selected for this study.
The subjects selected for this study are healthy females and males aged between 18 and 65 years, having dry skin with corneometer reading <30 on forearms.
STUDY DURATION: 100 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 with corneometer reading less than 30 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
Moisturization and Skin Barrier Function (trans epidermal water loss)
时间窗: Baseline, 2 hours, 24 hours, 48 hours, 100 hours
次要结局
未报告次要终点
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.