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NCT Number: NCT03659227

Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

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.

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Key information

Conditions

Stevens-Johnson Syndrome AGEP Bullous Dermatosis Caused by Drug Treatment (Disorder) Chemically-Induced Disorders Cicatrix DRESS Dermatitis Drug Eruptions Drug Hypersensitivity Drug Reactions Drug-Related Side Effects and Adverse Reactions Erythema Erythema Multiforme Fibrosis Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lyell Syndrome Maculopapular Exanthem Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henri Mondor

Créteil, 94010, France

Location status: Recruiting

Location contact

Saskia Oro, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Implementation of a clinical data and biological samples collection for cutaneous adverse reactions

    Time frame: Day 0

    Implementation of a clinical data and biological samples collection for cutaneous adverse reactions

Secondary outcomes

  1. To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.

    Time frame: Day 0

    To conduct clinical and biological (immunological, histological, microbiological and genetic) studies in cutaneous adverse reactions.

Study contacts

Contact information is provided by the study sponsor or research team.

Laetitia Gregoire

CONTACT

[email protected]

0149814164 ext. +33

Saskia Oro, MD

CONTACT

[email protected]

0149812536 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
Sep 6, 2018
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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