Back to resultsDrug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
Primary Purpose
Drug Reaction
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
patch test
Sponsored by
About this trial
This is an interventional other trial for Drug Reaction focused on measuring Drug patch tests
Eligibility 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
Sites / Locations
- Division of Dermatology, Faculty of Medicine, Chulalongkorn UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patch test arm
Arm Description
Patch test by selected allergens and drawing blood for ELIspot and LTT
Outcomes
Primary Outcome Measures
Prevalence of positive drug patch test results.
Secondary Outcome Measures
correlation of drug patch test results, ELIspot and lymphocyte transformation test.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03176342
Brief Title
Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2016 (Actual)
Primary Completion Date
August 3, 2017 (Anticipated)
Study Completion Date
August 3, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Reaction
Keywords
Drug patch tests
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patch test arm
Arm Type
Experimental
Arm Description
Patch test by selected allergens and drawing blood for ELIspot and LTT
Intervention Type
Other
Intervention Name(s)
patch test
Other Intervention Name(s)
Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT)
Intervention Description
Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous.
Primary Outcome Measure Information:
Title
Prevalence of positive drug patch test results.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
correlation of drug patch test results, ELIspot and lymphocyte transformation test.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Division of Dermatology, Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pawinee Rerknimitr, MD, MSc
Phone
+6622564253
Email
pawineererk@yahoo.co.th
First Name & Middle Initial & Last Name & Degree
Jettanong Klaewsongkram, MD
First Name & Middle Initial & Last Name & Degree
Suwimon Pootongkam, MD, MSc
First Name & Middle Initial & Last Name & Degree
Prattana Sittiwattanawong, MD
12. IPD Sharing Statement
Learn more about this trial
Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
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