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Brief Title


Official Title

Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

Brief Summary

      Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference
      center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson
      syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed
      drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and
      erythema multiforme). In order to conduct clinical and biological research studies in drug
      reactions, it is necessary for the investigator's department to implement a collection of
      clinical data and biological samples.

      Hypothesis/Objective: To collect clinical data and cutaneous and biological samples for
      immunological, biological and genetic studies to improve knowledge about pathophysiology of
      drug reactions.

      Method: The following samples will be performed in addition to the routine practice samples:
      one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous
      membrane and skin eSWABs, stool samples.

      These samples will be stored in a dedicated biological sampling department ("Platform of
      biological resources").

      Conclusion: The implementation of this collection should allow us to conduct
      pathophysiological studies about drug reactions.

Study Type


Primary Outcome

Implementation of a clinical data and biological samples collection for cutaneous adverse reactions

Secondary Outcome

 To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.


Stevens-Johnson Syndrome


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

September 26, 2018

Completion Date

September 25, 2028

Primary Completion Date

September 25, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Patient ≥ 18 y-old

          -  Severe cutaneous drug reaction (AGEP, DRESS, SJS/TEN, generalized bullous fixed drug
             eruption), drug-induced IgA bullous dermatosis, maculopapular exanthema, erythema

          -  Signed consent

          -  Social security affiliation

        Exclusion Criteria:

          -  Patients law protection




18 Years - N/A

Accepts Healthy Volunteers



Saskia Oro, MD, 0149812536, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

Saskia Oro, MD, Principal Investigator, APHP

Verification Date

April 2022