Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

Stevens-Johnson Syndrome Clinical Trial

Official title:

Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03659227
• Other study ID #: K180201J
• Status: Recruiting
• Start date: September 26, 2018
• Est. completion date: September 25, 2028

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Saskia Oro, MD
• Phone: 0149812536
• Email: saskia.oro[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 25, 2028
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AGEP
• Bullous Dermatosis Caused by Drug Treatment (Disorder)
• DRESS
• Drug Reactions
• Drug-Related Side Effects and Adverse Reactions
• Erythema
• Erythema Multiforme
• Lyell Syndrome
• Maculopapular Exanthem
• Skin Diseases
• Stevens-Johnson Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Henri Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0
Secondary	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.	Day 0