An observational study in Stevens-Johnson Syndrome, Lyell Syndrome and Drug Reactions, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
40 studies on the registry are indexed under Stevens-Johnson Syndrome; 8 are open to participants now.
Browse Stevens-Johnson Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Patients with severe cutaneous adverse reactions (DRESS, AGEP, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA linear dermatosis, maculo-papular exanthema, erythema multiforme.
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Exclusion Criteria:
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Time frame: Day 0
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
Time frame: Day 0
Started Sep 2018 (actual). Primary completion is estimated for Sep 2023, 59 months after the start.
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