Evaluation of irritation potential of Skin Care formulation 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
- 24
- 试验地点
- 1
- 主要终点
- Safety assessment of product
研究概览
简要总结
Single Application Semiocclusive, Closed Patch test is conducted to measure the irritation potentialof cosmetic products on the skin
Objective: To evaluatethe irritation potential on healthy human subjects of Skin CareFormulations.
Duration of study: 8 days study
Kinetics: T0 (Evaluation oftest sites by Dermatologist, Patch application)
T1(Patchremoval, Evaluation of test sites by Dermatologist
T2(Evaluationof test sites by Dermatologist and Subject post 24 hrs of patchremoval),
T8 (Evaluation of testsites by Dermat and Subject post 1 week of patch removal and tracking thepositive cases)
Population: 24 healthy subjects(12 males + 12 females)
The test area is checked forerythema and oedema caused due to the products and compared with positivecontrol.
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, oriasis, 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 assessment of product
时间窗: Baseline,0 hrs,24 hrs and 7 days
次要结局
- Not Applicable(Not Applicable)