Actively Recruiting
Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2022-05-03
500
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting clinical data and biological samples from patients with severe skin reactions caused by drugs. These conditions include Stevens-Johnson syndrome, Lyell syndrome (toxic epidermal necrolysis), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), drug-induced immunoglobulin A (IgA) bullous dermatosis, generalized bullous fixed drug reactions, maculopapular exanthema, and erythema multiforme. The goal is to better understand the biological and genetic causes of these drug reactions through research. Participants will provide various samples beyond routine care, including a small skin biopsy (6 mm punch), blood samples (43 mL), blister fluid, oral and nasal mucous membrane swabs, skin swabs, and stool samples. These samples will be stored in a specialized biological resource platform to allow detailed immunological, biological, and genetic studies. This is an observational study without specific treatment interventions. During the study, patients will undergo collection of clinical information and the biological samples described. Researchers will monitor the implementation of this collection and use the data and samples to perform various laboratory studies to explore the mechanisms of adverse drug reactions affecting the skin. Participation involves consenting and providing samples as outlined, with no therapeutic procedures. The study began in September 2018 and is expected to continue until 2028.
CONDITIONS
Brief Title
Drug Reactions Sampling (COLLECTIONTOXIDERMIES)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or older
- Diagnosis of severe cutaneous drug reaction such as AGEP, DRESS, SJS/TEN, generalized bullous fixed drug eruption, drug-induced IgA bullous dermatosis, maculopapular exanthema, or erythema multiforme
- Signed informed consent
- Affiliated with social security
You will not qualify if you...
- Patients under legal protection or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 0
Participants undergo clinical and biological assessments for cutaneous adverse drug reactions.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Henri Mondor
Créteil, France, 94010
Actively Recruiting
Research Team
S
Saskia Oro, MD
L
Laetitia Gregoire
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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