Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Recruiting now

Conditions studied: Stevens-Johnson Syndrome, Lyell Syndrome, Drug Reactions, AGEP, DRESS, Bullous Dermatosis Caused by Drug Treatment (Disorder), Maculopapular Exanthem, Erythema Multiforme

In brief

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.

Key facts

Study ID
NCT03659227
Run by
Assistance Publique - Hôpitaux de Paris
People needed
500
Starts
2018-09-26
Expected to finish
2028-09-25
Last updated by the study team
2022-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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