Evaluation of of Irritation Potential of Skin Care Formulations.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To evaluate the dermatological safety of
研究概览
简要总结
Single Application Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.
Objective : To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers .
Duration of study: 8 days study
**Kinetics: T0 (Patch application),**T1(Patch removal), T2(Evaluation of test sitesby Dermat post 24 hrs of patch removal), T8 (Evaluation of test sitesby Dermat post 1 week of patch removal and tracking the positive cases)
Population 26 healthy subjects(13 males + 13 females)
Products : Lubes- Warming (MNWL-026) , Lubes -Strawberry (MNFL-016) , Lubes - Cherry (MNFL-019) , Lubes - Cool – Banana( MNCL-021) , Lubes - Cool - Mint (MNCL-024) Positive control: 3% SLS
Negative control: Distilled water
The test area is checked for erythema and oedema caused due to the products and
compared with positive control
products were non irritant to skin
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
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/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic, Being asthmatic, Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis.
结局指标
主要结局
To evaluate the dermatological safety of
时间窗: T0- baseline | T1-patch removal | T2- dermat grading | T8- follow up
investigational products by primary irritation
时间窗: T0- baseline | T1-patch removal | T2- dermat grading | T8- follow up
patch test on healthy human volunteers
时间窗: T0- baseline | T1-patch removal | T2- dermat grading | T8- follow up
次要结局
- Not Applicable(Not Applicable)