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临床试验/NCT04142489
NCT04142489已完成不适用

Clinical Study of In Vivo Damage Induced bu UV in the Epidermis of the Scalp

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
number oh epidermal cells positives

研究概览

简要总结

Squamous cell carcinomas (SCC) are the second most common skin cancer in humans. The incidence of SCCs in the USA in 2012 was estimated at 700,000 casesSCCs have a metastatic course in 3% to 5% of cases that is of poor prognosis. In men, the SCCs of the scalp represent the most frequent location of the head and neck, the 3rd location of the whole body. The SCCs of the scalp are more undifferentiated than in other locations. In addition, actinic keratoses of scalp, precursors of SCC, are more resistant to treatment than in other areas. These particularities of the SCCs of the scalp suggest the existence of specific factors at the epidermis level of the scalp.

UV-induced damage to DNA is the defining event in skin photocarcinogenesis. It has already been shown that DNA damage induced by UV and the kinetics of repair of this damage may vary with age or phototype of patients, but the topographic variation of DNA damage has never been studied, although it is known that gene expression in skin cells may differ from one region of the body to another.

the hypothesis is therefore that the particular characteristics of KAs and SCCs at the scal level could be explained by an increased sensitivity to UV-induced damage. It is planned to study UV-induced damage and its repair at the scalp level in humans compared to the forearm.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male subject
  • Subject aged 40 to 60 years
  • Subject of phototype III or IV
  • Subject with no skin lesions on the scalp and forearms
  • Subject who has not been exposed to the sun for at least 1 month
  • Subject affiliated to social security
  • Subject who signed the informed consent form

排除标准

  • Subjects with photosensitivity,
  • Subject taking photosensitizing drugs
  • Subjects with a history of skin cancer
  • Subjects with abnormal healing
  • Subjects with immunosuppression

结局指标

主要结局

number oh epidermal cells positives

时间窗: 6 months

epidermal cells with positive immunolabeling for DNA damage markers (CPD, 6.4PP, p53) count.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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