NCT02108483已完成1 期
Phototoxicity Test of Dapsone Gel in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Phototoxicity Irritation Potential Using a Visual Scale
研究概览
简要总结
This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic reaction following irradiation of the skin under controlled conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults.
排除标准
- •Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
- •Sensitivity to adhesive bandages or tape.
研究组 & 干预措施
All participants
Experimental
Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches on Day 1.
干预措施: dapsone gel (Drug)
All participants
Experimental
Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches on Day 1.
干预措施: dapsone gel vehicle (Drug)
结局指标
主要结局
Phototoxicity Irritation Potential Using a Visual Scale
时间窗: 4 Days
次要结局
未报告次要终点
研究者
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