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

NCT ID: NCT03176342

Last Updated: 2017-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-04

Study Completion Date

2017-08-03

Brief Summary

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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.

Detailed Description

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Conditions

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Drug Reaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patch test arm

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

Group Type EXPERIMENTAL

patch test

Intervention Type OTHER

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

Interventions

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patch test

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

Intervention Type OTHER

Other Intervention Names

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Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pawinee Rerknimitr

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Dermatology, Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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Pawinee Rerknimitr, MD, MSc

Role: primary

+6622564253

Other Identifiers

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204/59

Identifier Type: -

Identifier Source: org_study_id

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