NCT05780840招募中不适用
Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Visible light exposure dose to onset of first skin symptom
研究概览
简要总结
What is the visible light protective effect of dihydroxyacetone in individuals with erythropoietic protoporphyria? This will be tested in this randomized blinded placebo controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with erythropoietic protoporphyria
- •At least 18 years of age
- •Obtainment of written informed consent
排除标准
- •Pregnant or breastfeeding
- •Use of dihydroxyacetone at the treatment or placebo fields within the last two week
- •Sun exposure of the treatment or placebo fields within the last two week
- •Use of suncreen or other local treatment on the treatment or placebo fields during the study period (two days)
- •Allergy to adhesive bandages, dihydroxyacetone or lotion
结局指标
主要结局
Visible light exposure dose to onset of first skin symptom
时间窗: Meassurement one day after dihydroxyacetone application
Assessed by phototesting
次要结局
- Change in skin color from before treatment to one day after treatment(Meassurement of skin color just before dihydroxyacetone application and one day after application.)
研究者
Ida M. Heerfordt
Principal Investigator
Bispebjerg Hospital
研究点 (2)
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