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Recruiting NCT03659227

Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Trial Parameters

Condition Stevens-Johnson Syndrome
Sponsor Assistance Publique - Hôpitaux de Paris
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2018-09-26
Completion 2023-09-25

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.

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 multiforme * Signed consent * Social security affiliation Exclusion Criteria: * Patients law protection

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