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

NCT03176342 | Unknown

• 1 other identifier: 204/59
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Reaction

Keywords

Drug patch tests

Outcome Measures

Primary Outcomes (1)

• Prevalence of positive drug patch test results.

  3 years

Secondary Outcomes (1)

• correlation of drug patch test results, ELIspot and lymphocyte transformation test.

  3 years

Study Arms (1)

patch test arm

EXPERIMENTAL

Patch test by selected allergens and drawing blood for ELIspot and LTT

Other: patch test

Interventions

patch test OTHER

Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous.

Also known as: Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT)

patch test arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Division of Dermatology, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Patch Tests; Enzyme-Linked Immunospot Assay

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Cytological Techniques; Enzyme-Linked Immunosorbent Assay; Immunoenzyme Techniques; Immunoassay; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 5, 2017
• Study Start: August 4, 2016
• Primary Completion: August 3, 2017
• Study Completion: August 3, 2017
• Last Updated: June 6, 2017

Record last verified: 2017-06

Locations

TH (1)