About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients law protection
Trial population
Patients with severe cutaneous adverse reactions (DRESS, AGEP, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA linear dermatosis, maculo-papular exanthema, erythema multiforme.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Implementation of a clinical data and biological samples collection for cutaneous adverse reactions
Secondary outcomes
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.