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Status unknownNCT03176342Updated Jun 6, 2017

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

An interventional study of patch test in Drug Reaction, sponsored by Chulalongkorn University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-06.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Aug 2016, registered Jun 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Drug Reaction

Keywords

  • Drug patch tests
03

In context

Drug-Related Side Effects and Adverse Reactions

437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.

This study's planned enrollment of 30 is below the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Receiving immunosuppressive drugs or more than 10 mg/day of prednisolone within 1 month.
  • Pregnancy and lactation
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    patch test arm

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

    Other: patch test

Interventions

  • Otherpatch test

    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)

06

What researchers measure

Primary outcomes

  1. Prevalence of positive drug patch test results.

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Division of Dermatology, Faculty of Medicine, Chulalongkorn University
    Bangkok, 10330, Thailand
    • Pawinee Rerknimitr, MD, MSc · Contact · pawineererk@yahoo.co.th · +6622564253
    • Jettanong Klaewsongkram, MD · Sub investigator
    • Suwimon Pootongkam, MD, MSc · Sub investigator
    • Prattana Sittiwattanawong, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03176342
Lead sponsor
Chulalongkorn University
Responsible party
Pawinee Rerknimitr (Assistant professor, Chulalongkorn University) — Principal investigator
First posted
Jun 5, 2017
Start date
Aug 4, 2016
Primary completion
Aug 3, 2017 (estimated)
Completion
Aug 3, 2017 (estimated)
Last update
Jun 6, 2017

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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