Drug Patch Tests in Patients With Severe Cutaneous Advers... | NCT03176342

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

NCT03176342

Sponsor

Chulalongkorn University

Status

Unknown status

Last Update Posted

Jun 6, 2017Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Drug Reaction

Interventions

patch test

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 4, 2016Actual

Primary Completion Date

Aug 3, 2017Estimated

Completion Date

Aug 3, 2017Estimated

First Submitted Date

Jun 2, 2017

First Submission Date that Met QC Criteria

Jun 2, 2017

First Posted Date

Jun 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2017

Last Update Posted Date

Jun 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pawinee Rerknimitr, Assistant professor, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patch test arm	Experimental	Patch test by selected allergens and drawing blood for ELIspot and LTT	Other: patch test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
patch test	Other	Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous.	patch test arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Dermatology, Faculty of Medicine, Chulalongkorn University	Recruiting	Bangkok		10330	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010328	Patch Tests
D058501	Enzyme-Linked Immunospot Assay

Ancestor Terms

ID	Term
D012882	Skin Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided