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Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

NCT03659227 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-05-03

No results posted yet for this 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.

Conditions

  • Stevens-Johnson Syndrome
  • Lyell Syndrome
  • Drug Reactions
  • AGEP
  • DRESS
  • Bullous Dermatosis Caused by Drug Treatment (Disorder)
  • Maculopapular Exanthem
  • Erythema Multiforme

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Saskia Oro, MD · APHP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2023-09-25
Completion
2028-09-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659227 on ClinicalTrials.gov