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RECRUITING
NCT03659227

Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2018-09-26

Completion Date

2028-09-25

Last Updated

2022-05-03

Healthy Volunteers

No

Locations (1)

Henri Mondor

Créteil, France