To evaluate the in vivo safety and efficacy of skin care formulation in terms of improvement in skin brightness on healthy human subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Improvement in skin brightness
研究概览
简要总结
OBJECTIVE:The objective of this study is to evaluate the in-vivo safety and efficacy ofskin care formulation in terms of improvement in skin brightness on healthyhuman subjects
Theevaluation is performed using: Subject Self Evaluation (SSE), DermatologicalEvaluation: Cosmetic Acceptability, Chromametry
POPULATION:36 (18 male and 18 female) subjects will be selected for the study.
Thesubjects selected for this study will be healthy females & male, agedbetween 18 and 45 years, having wheatish to dark complexion.
STUDYDURATION: Duration: 28 days following the first application of the product.
STUDYDESIGN : Single blind study, Non-Comparative study, Subjects will serve astheir own references.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian male and female subjects.
- •Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having wheatish to dark complexion.
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
Improvement in skin brightness
时间窗: Baseline, Day 7, Day 14 and Day28
次要结局
未报告次要终点