Evaluation of the sensitization potential of Skin, Hair, Lip and Dental Care Formulations 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
- 220
- 试验地点
- 1
- 主要终点
- Sensitization potential
研究概览
简要总结
The objective of this study will be to evaluate the sensitization potential of Skin, Hair, Lip and Dental care formulations on healthy human subjects
The evaluation is performed using: Dermatological Evaluation: Human Repeat Insult Patch Test Method
Total duration of the study: 40 days following the first application of product.
Kinetics: Induction phase with 21 visits( T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19 and T20) then resting phase of 14 days and 5 days of Challenge phase( T21, T22, T23, T24 & T25)
**The study is conducted in 3 phases: 1.****Induction Phase, 2.****Resting Phase,3.**Challenge Phase
Induction phase is of 21 days and in which 9 repeated applications of patches are carried out which are removed after 24 hours of application and evaluated after 24 hours of patch removal. Resting phase is of 14 days in which no application of any patch is done in order to develop sensitization to the test product. In Challenge phase only one patch is applied which is removed after 24 hours and evaluated after 24 hours 48 hours and 72 hours
Number of volunteers: 220 (110 male+110 female) subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor 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
- •Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit.
排除标准
- •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •Having refused to give his or her assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being diabetic.
- •Being asthmatic.
- •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 (except in the case of studies with evaluation of sensitive skin).
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Having changed his or her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
结局指标
主要结局
Sensitization potential
时间窗: Day 2, Day 3, Day 4, Day 5, Day 6, Day 7,Day9, Day 10, Day 11, Day 12, Day 13, Day 14, Day 16, Day 17, Day 18, Day 19, Day 20, Day 21, Day 38, Day 39, Day 40
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.