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Recruiting Observational

Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

NCT03659227 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2018-09-26
Last updated
2022-05-03

Condition(s) studied

Stevens-Johnson SyndromeLyell SyndromeDrug ReactionsAGEPDRESSBullous Dermatosis Caused by Drug Treatment (Disorder)Maculopapular ExanthemErythema Multiforme

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Patients law protection

Primary outcome measure(s)

  • Implementation of a clinical data and biological samples collection for cutaneous adverse reactions — Day 0
    Implementation of a clinical data and biological samples collection for cutaneous adverse reactions

Trial sites (1)

FacilityCityRegionStatus
Henri Mondor Créteil France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03659227 on ClinicalTrials.gov ↗ ← All trials in France