Actively Recruiting

Age: 18Years +
All Genders
ID03659227

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Patients under legal protection or guardianship

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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

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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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