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临床试验/NCT03176342
NCT03176342Unknown不适用

Drug Patch Tests, Enzyme-linked Immunosorbent Spot Assay (Elispot) and Lymphocyte Transformation Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年8月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Prevalence of positive drug patch test results.

研究概览

简要总结

The study is about drug patch tests in patients who have history of severe cutaneous drug reaction including Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), Drug-induced eosinophilia and systemic symptoms (DRESS), AGEP (Acute generalized exanthematous pustulosis) and generalized bullous fixed drug eruptions. This study also investigate in Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test. We also trying to prove the correlation among result of drug patch tests, ELIspot and LTT.

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

入选标准

  • Patients with history of Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug-induced eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), generalized bullous fixed drug eruption in the past 24 months.
  • Age more than 18 years old

排除标准

  • Receiving immunosuppressive drugs or more than 10 mg/day of prednisolone within 1 month.
  • Pregnancy and lactation

结局指标

主要结局

Prevalence of positive drug patch test results.

时间窗: 3 years

次要结局

  • correlation of drug patch test results, ELIspot and lymphocyte transformation test.(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pawinee Rerknimitr

Assistant professor

Chulalongkorn University

研究点 (2)

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