Evaluation of irritation potential of Skin Care formulation on healthy human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Safety / irritation potential of product
研究概览
简要总结
Closed Patch test is conducted to measure the irritation potential of cosmetic product on the skin
Objective: To evaluate the irritation potential on healthy human subjects of Skin Care Formulation.
Duration of study: 8 days study
Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application)
T1(Patch removal, Evaluation of test sites by Dermatologist
T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal),
T8 (Evaluation of test sites by Dermat and Subject post 1 week of patch removal and tracking the positive cases)
Population: 26 healthy subjects (13 males + 13 females)
The test area is checked for erythema and oedema caused due to the products and compared with positive control.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Human Subjects 2) is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
- •Subjects willing to come for regular follow up and ready to follow instructions during the study period.
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, Poriasis, 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
Safety / irritation potential of product
时间窗: T0 (before patch application), T1 day (0 hour after the patch removal), T2 days (24 hours after the patch removal), T8 days (1 week after 0 hour of patch removal)
次要结局
未报告次要终点