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

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ClinicalTrials.gov Identifier: NCT03176342
Recruitment Status : Unknown
Verified June 2017 by Pawinee Rerknimitr, Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : June 5, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pawinee Rerknimitr, Chulalongkorn University

Brief 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.

Condition or disease Intervention/treatment Phase
Drug Reaction Other: patch test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Drug Patch Tests, Enzyme-linked Immunosorbent Spot Assay (Elispot) and Lymphocyte Transformation Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
Actual Study Start Date : August 4, 2016
Estimated Primary Completion Date : August 3, 2017
Estimated Study Completion Date : August 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: patch test arm
Patch test by selected allergens and drawing blood for ELIspot and LTT
Other: patch test
Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous.
Other Name: Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT)




Primary Outcome Measures :
  1. Prevalence of positive drug patch test results. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. correlation of drug patch test results, ELIspot and lymphocyte transformation test. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176342


Locations
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Thailand
Division of Dermatology, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Pawinee Rerknimitr, MD, MSc    +6622564253    pawineererk@yahoo.co.th   
Sub-Investigator: Jettanong Klaewsongkram, MD         
Sub-Investigator: Suwimon Pootongkam, MD, MSc         
Sub-Investigator: Prattana Sittiwattanawong, MD         
Sponsors and Collaborators
Chulalongkorn University

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Responsible Party: Pawinee Rerknimitr, Assistant professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03176342     History of Changes
Other Study ID Numbers: 204/59
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Pawinee Rerknimitr, Chulalongkorn University:
Drug patch tests

Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders