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)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
patch test arm
Experimental
Patch test by selected allergens and drawing blood for ELIspot and LTT
干预措施: patch test (Other)
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
Pawinee Rerknimitr
Assistant professor
Chulalongkorn University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Cutaneous Adverse Drug Eruption: Identifiable with Drug Patch Testing?Cutaneous drug eruptionDrug patch testTCTR20200107003one122
已完成
1 期
A Safety Study to Investigate the Skin Sensitization Potential of MFC51123PainNCT02192203GlaxoSmithKline227
已完成
不适用
Multi-Centre European Photopatch Test StudyDermatitis, PhotocontactNCT00530387NHS Tayside1,000
已完成
3 期
Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)HypersensitivityNCT04531813Bayer32
已完成
1 期
A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol GelPainNCT02169154GlaxoSmithKline36