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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03176342
• Date of registration: 02/06/2017
• Prospective Registration: No
• Primary sponsor: Chulalongkorn University
• Public title: Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
• Scientific title: Drug Patch Tests, Enzyme-linked Immunosorbent Spot Assay (Elispot) and Lymphocyte Transformation Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
• Date of first enrolment: August 4, 2016
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03176342
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Pawinee Rerknimitr, MD, MSc

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Drug Reaction

Intervention(s)

Other: patch test

Primary Outcome(s)

Prevalence of positive drug patch test results. [Time Frame: 3 years]

Secondary Outcome(s)

correlation of drug patch test results, ELIspot and lymphocyte transformation test. [Time Frame: 3 years]

Secondary ID(s)

204/59

Source(s) of Monetary Support

Please refer to primary and secondary sponsors