To evaluate and compare the in-vivo safety and efficacy of Skin care formulation in terms of 48 hours odour suppression, skin brightness and skin hydration on healthyhuman 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
- 48 hours odour suppression, skin brightness and skin hydration
研究概览
简要总结
OBJECTIVE: The objectiveof this study is to evaluate and compare the in-vivo safety & efficacy ofSkin care formulation in terms of 48 hours odour suppression, skin brightnessand skin hydration on healthy human subjects.
The evaluation isperformed using: Subject Self Evaluation (SSE), Dermatological Evaluation:Safety, Expert Evalution for Efficacy by Axillary Odour Test, Corneometry, Chromametry
POPULATION: 36 (18 maleand 18 female) healthy subjects are selected for the study.
The subjects selectedfor this study are healthy human subjects, aged between 18 and 50 years, havingmild to moderate body odour & having a habit of using deodorant.
All 36 subjects will useProduct A on randomized underarm & another underarm will be considered asuntreated control.
STUDY DURATION: 48 hoursfollowing the first application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having mild to moderate body odour.
- •Having a habit of using deodorant.
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
48 hours odour suppression, skin brightness and skin hydration
时间窗: Baseline, 30 minutes, 24 hours and 48 hours after product application
次要结局
未报告次要终点