NCT03659227

Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2018-09-26
• Primary completion: 2023-09-25
• Completion: 2028-09-25
• First posted: 2018-09-06
• Last updated: 2022-05-03

Locations

1 site across 1 country: France