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Drug Reactions Sampling (COLLECTIONTOXIDERMIES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03659227
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.


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

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : September 25, 2023
Estimated Study Completion Date : September 25, 2028





Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
  • one skin punch biopsy
  • blood (serum, cells, DNA and RNA studies);
  • blister fluid aspiration;
  • oral and nose mucous membrane and skin eSWABs ;
  • stool samples.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe cutaneous adverse reactions (DRESS, AGEP, SJS/TEN, generalized bullous fixed drug eruption), drug-induced IgA linear dermatosis, maculo-papular exanthema, erythema multiforme.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659227


Contacts
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Contact: Saskia Oro, MD 0149812536 ext +33 saskia.oro@aphp.fr
Contact: Laetitia Gregoire 0149814164 ext +33 laetitia.gregoire@aphp.fr

Locations
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France
Henri Mondor Recruiting
Créteil, France, 94010
Contact: Saskia Oro, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Saskia Oro, MD APHP

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03659227    
Other Study ID Numbers: K180201J
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Drug reactions
severe cutaneous adverse reactions (SCARs
Stevens-Johnson syndrome
Lyell Syndrome
(generalized bullous) fixed drug reaction
AGEP
DRESS
drug induced IgA bullous dermatosis
maculopapular exanthema
erythema multiforme
sampling
collection
Additional relevant MeSH terms:
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Stevens-Johnson Syndrome
Erythema
Skin Diseases
Skin Diseases, Vesiculobullous
Erythema Multiforme
Drug Eruptions
Syndrome
Drug-Related Side Effects and Adverse Reactions
Disease
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Chemically-Induced Disorders
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Dermatitis
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases