Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10
研究概览
简要总结
Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema.
Study design: A single-center, prospective, randomized, crossover, open study.
Number of patients: 20-40
Patient population: Healthy volunteers
Control: Different sites on patients body
Procedure duration: Total 3-5 hours (4 visits)
Duration of follow up: 4 days
Duration of study: Up to 6 months
Primary objectives: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick Skin types I-III.
- •Absence of obvious sun damage on the volar side of the forearm or other exposure sites.
- •Absence of exposure of the arms or other exposure sites to sunlight for two weeks prior to the experiment.
排除标准
- •History of skin cancer.
- •Multiple nevi or atypical nevi on the forearm.
- •Signs of sun damage on the volar side of the forearm or other exposure sites.
- •Mentally incompetent.
结局指标
主要结局
To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10
时间窗: end of study
次要结局
未报告次要终点