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Duration: 01.2003 – ongoing

Primary investigator: PD Dr. Maja Mockenhaupt (Dept. of dermatology, Medical Center - University of Freiburg)

Project leader biometry: Prof. Dr. Martin Schumacher (IMBI)

Study statistician: Dipl.-Math. (FH) Peggy Sekula (IMBI)


Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), acute generalised exanthematous pustulosis (AGEP), hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (HSS/DRESS) and generalized bullous fixed drug eruption are rare but very severe cutaneous adverse reactions (SCAR) to drugs with high morbidity and mortality.

The practical objectives of this study are:

  1. to build an International Registry of SCAR for continuous surveillance of new drugs with adequate pharmaco-epidemiologic methodology and for providing reference information on SCAR,
  2. to organise a standardized collection of biological samples (plasma, lymphocytes, DNA and skin) to allow high quality studies on pharmaco-genetics and investigations of the mechanisms of these reactions, and
  3. to constitute a cohort of patients in order to study the outcome, prognosis factors, sequelae and impact on quality of life of these severe side effects of medicine.


Current RegiSCAR-projects with IMBI contribution:

  • systematic review on immunomodulating therapies for patients with Stevens-Johnson syndrome or toxic epidermal necrolysis
  • causality assessment of drugs in patients with Stevens-Johnson syndrome or toxic epidermal necrolysis
  • analysis of data on sequelae and quality of life after 1 year/after 5 years of Stevens-Johnson syndrome or toxic epidermal necrolysis