NCT05245383Unknown不适用
Skin Irritation Test of Ten Products
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety/Adverse Event Outcome Measure
研究概览
简要总结
Evaluation of cutaneous tolerance of ten products by primary irritant patch test
详细描述
The purpose of this clinical study was the evaluation of skin irritation potential of ten products after a single application under occlusive patch on human skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 to 70 years old, healthy male and female (sex ratio 1:1)
- •No acute or chronic diseases including skin diseases.
- •No current medications.
排除标准
- •Pregnancy or breast feeding.
- •Abnormal blood test result/results (evaluation criteria: WBC, AST, ALT, and Creatinine)
- •Back skin with moles, acne, tattoo, scars, red spots, burns, etc.
- •Current dermatology medication which might affect skin condition evaluation.
- •Current irritated reaction on test site.
- •Participating in other clinical trial(s) within 7 days.
结局指标
主要结局
Safety/Adverse Event Outcome Measure
时间窗: Up to 48 hours
Number of participants with Serous and Non-Serous Adverse Event
Total Number of Positive Responses Across All Participants
时间窗: Reading results at 30 minutes, 24 hours and 48 hours after the removal of the test products.
Change from baseline of test products by using ICDRG (International Contact Dermatitis Research Group) grading
次要结局
未报告次要终点
研究者
研究点 (1)
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