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…
- 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
You may not qualify if…
- Patients law protection
Where it is running
- Henri Mondor — Créteil, France (enrolling)
Full record on ClinicalTrials.gov
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