NCT05368857已完成1 期
A Mechanistic Study to Evaluate Impact of Subcutaneous Implants of Afamelanotide on Ultraviolet Radiation-induced DNA Damage and DNA Repair Capacity in Healthy Volunteers With Skin Types I-III
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
- 10
- 试验地点
- 1
- 主要终点
- Change in UV photoproduct levels in UVR-exposed skin.
研究概览
简要总结
This mechanistic study's aim is to assess the DNA damage repair capabilities of afamelanotide in healthy volunteers with skin type I-III following exposure to ultraviolet radiation (UVR)-induced DNA damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers (aged 18-45) with Fitzpatrick skin types I, II or III.
- •Written informed consent obtained from volunteers prior to study-start.
排除标准
- •Female who is pregnant or lactating.
- •Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.
- •Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
- •Any significant illness during the four weeks before the study screening period.
- •Taking known photosensitisers.
研究组 & 干预措施
Afamelanotide
Experimental
干预措施: Afamelanotide (Drug)
结局指标
主要结局
Change in UV photoproduct levels in UVR-exposed skin.
时间窗: From Baseline to Day 28
Analysis of UV photoproducts from skin samples.
Change in rate of UV photoproduct repair in UVR-exposed skin.
时间窗: From Baseline to Day 28.
Analysis of UV photoproduct repair mechanisms from skin samples.
次要结局
- Change in UV-induced DNA damage and repair markers.(From Baseline to Day 28)
- Change in Minimal Erythema Dose (MED).(From Baseline to Day 28)
- Change in UVR-erythema dose-response.(From Baseline to Day 28)
研究者
研究点 (1)
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