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

Drug Reaction Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03176342
• Other study ID #: 204/59
• Status: Recruiting
• Phase: N/A
• First received: June 2, 2017
• Last updated: June 3, 2017
• Start date: August 4, 2016
• Est. completion date: August 3, 2017

Study information

• Verified date: June 2017
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 3, 2017
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Reaction
• Drug-Related Side Effects and Adverse Reactions

Intervention

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

Locations

Country	Name	City	State
Thailand	Division of Dermatology, Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of positive drug patch test results.		3 years
Secondary	correlation of drug patch test results, ELIspot and lymphocyte transformation test.		3 years