Photoallergy Potential of Dapsone Gel in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Photoallergic (Sensitizing) 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 photoallergic reaction after repeated application and irradiation to the skin of healthy volunteers 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
Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches twice a week for 21 days followed by a 10 to 17 day rest period then another application of dapsone gel and dapsone gel vehicle by patch.
干预措施: dapsone gel (Drug)
All Participants
Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches twice a week for 21 days followed by a 10 to 17 day rest period then another application of dapsone gel and dapsone gel vehicle by patch.
干预措施: dapsone gel vehicle (Drug)
结局指标
主要结局
Photoallergic (Sensitizing) Potential Using a Visual Scale
时间窗: Week 6
次要结局
未报告次要终点