Drug ReactionNCT03176342
Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
A study testing patch test in people with Drug Reaction, run by Chulalongkorn University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Reaction
- What is being tested?
- patch test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 4 Aug 2016to 3 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Receiving immunosuppressive drugs or more than 10 mg/day of prednisolone within 1 month.
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Pawinee Rerknimitr, MD, MSc, +6622564253, pawineererk@yahoo.co.th
Jettanong Klaewsongkram, MD
About this study
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)
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
- Being tested
- patch test
- Keywords
- Drug patch tests
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patch testOther
Also called Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT)
Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous.
| Study group | Role | What they receive |
|---|---|---|
| patch test arm | Experimental | Patch test by selected allergens and drawing blood for ELIspot and LTT Receives: Other: patch test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of positive drug patch test results.
Measured: 3 years
Secondary outcomes (1)
correlation of drug patch test results, ELIspot and lymphocyte transformation test.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start4 Aug 2016
- Primary completion3 Aug 2017 (estimated)
- Study completion3 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawinee Rerknimitr, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176342
- Sponsor's protocol ID
- 204/59
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03176342
- Acronym / sponsor ID
- 204/59
- Conditions
- Drug Reaction
- Keywords
- Drug patch tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 3 Aug 2017 (estimated)
- Study completion
- 3 Aug 2017 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patch test arm | Experimental | Other: patch testPatch test by selected allergens and drawing blood for ELIspot and LTT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Receiving immunosuppressive drugs or more than 10 mg/day of prednisolone within 1 month.
- Pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patch testAlso: Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test (LTT)Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous. | Other | patch test arm |
Primary outcome
Prevalence of positive drug patch test results.
Time frame: 3 years
1 secondary outcome
correlation of drug patch test results, ELIspot and lymphocyte transformation test.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patch test in people with Drug Reaction, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of positive drug patch test results. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.