NCT00645164已完成1 期
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Frequency Distribution of Skin Irritation Scores
研究概览
简要总结
The product is being tested to see if exposure to light causes photoallergic reactions on the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
排除标准
- •Less than 18 years
研究组 & 干预措施
Xenaderm
Experimental
Subject serves as own control
干预措施: Ointment Vehicle (Other)
Xenaderm
Experimental
Subject serves as own control
干预措施: Xenaderm (Drug)
结局指标
主要结局
Frequency Distribution of Skin Irritation Scores
时间窗: 48-hours post irradiation
Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher.
次要结局
未报告次要终点
研究者
研究点 (1)
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