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

June 3, 2017 updated by: Pawinee Rerknimitr, Chulalongkorn University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Division of Dermatology, Faculty of Medicine, Chulalongkorn University
        • Contact:
        • Sub-Investigator:
          • Jettanong Klaewsongkram, MD
        • Sub-Investigator:
          • Suwimon Pootongkam, MD, MSc
        • Sub-Investigator:
          • Prattana Sittiwattanawong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of positive drug patch test results.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
correlation of drug patch test results, ELIspot and lymphocyte transformation test.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2016

Primary Completion (Anticipated)

August 3, 2017

Study Completion (Anticipated)

August 3, 2017

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 3, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 204/59

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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