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Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)

NCT03176342 — Not applicable, Unknown, 30 participants, Chulalongkorn University
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Drug Patch Tests, Enzyme-linked Immunosorbent Spot Assay (Elispot) and Lymphocyte Transformation Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)

RegistryNCT03176342
StatusUnknown
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment30 (Estimated)
SponsorChulalongkorn University (Other)
ConditionsDrug Reaction
Interventionspatch test (Other)
Datesstart 2016-08-04, primary completion 2017-08-03 (estimated), completion 2017-08-03 (estimated), first posted 2017-06-05, last updated 2017-06-06
Locations1 site in Thailand

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-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
patch test armExperimentalOther: patch testPatch test by selected allergens and drawing blood for ELIspot and LTT
  • patch test (Other), also known as Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT): Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous.

+Outcome measures

Primary outcomes

  • Prevalence of positive drug patch test results. [3 years]

Secondary outcomes

  • correlation of drug patch test results, ELIspot and lymphocyte transformation test. [3 years]

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

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

+Locations (1)

FacilityCityCountryStatus
Division of Dermatology, Faculty of Medicine, Chulalongkorn UniversityBangkokThailandRecruiting

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