跳至主要内容
临床试验/NCT01516788
NCT01516788已完成不适用

Photoprovocation Testing in Subjects With Cutaneous Lupus

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.

研究概览

简要总结

Photosensitivity is well documented among lupus patients and is one of the diagnostic criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly defined in lupus and its pathogenesis is not well understood. The purpose of this study is to characterize the early clinical and histopathological changes in lupus skin that occur as a response to ultraviolet light.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who have a diagnosis of CLE based on either the Gilliam classification of DLE and SCLE, or SLE based on the American College of Rheumatology criteria.

排除标准

  • Participants who do not meet criteria for either CLE or SLE.
  • Participants with a diagnosis of Erythropoietic Protoporphyria and Solar Urticaria, or another photodermatoses other than Polymorphous light eruption.
  • Participants who are not yet 18 years old or who are not capable of giving written informed consent prior to enrolling in the study.
  • Participants who have undergone any recent phototesting, or phototherapy exposure, or those who are suspected of having a drug-induced photosensitivity.
  • Female participants who are pregnant or breastfeeding will be excluded from the study. This will be determined by patient self-reporting.

结局指标

主要结局

The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.

时间窗: 24 hours and 48 hours

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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