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Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum (STADEH)

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: NCT04274348
Recruitment Status : Not yet recruiting
First Posted : February 18, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:
Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Clinical studies have demonstrated a link between staphylococcal skin colonization and the pathogenesis of AD, but the implication of bacterial virulence factors remains largely uncharacterized. Finally, AD is often associated with herpes simplex skin infections. The aim of this project is to investigate the role of staphylococcal toxins in the exacerbation and maintenance of atopic skin inflammation and in the occurrence of infectious complications such as eczema herpeticum.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Staphylococcus Aureus Bacterial Toxins Immune Response Cytokines T Cells Subsets Other: Skin biopsies and blood samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Eczema

Arm Intervention/treatment
Skin biopsies and blood samples Other: Skin biopsies and blood samples
Two skin biopsies and 30 ml of blood will be collected.




Primary Outcome Measures :
  1. Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions. [ Time Frame: 2 hours (with consultation and sample) ]
    Biological data obtained from lesional skin will be compared with those of healthy skin.


Secondary Outcome Measures :
  1. Determination of the inflammatory profile of skin and blood during AD. Definition of the seric cytokine signature characteristic of AD. Characterization of the phenotype and function of the lymphocytic infiltrate T during AD. [ Time Frame: 2 hours (with consultation and sample) ]
    Biological data obtained from lesional skin will be compared with those of healthy skin.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with moderate AD (SCORAD between 25 and 50) or severe AD (SCORAD> 50)
  • Skin lesions in the forearms
  • Free subject, without neither guardianship, wardship nor subordination
  • Patient with Social Security
  • Informed and signed consent by the patient after clear and loyal information on the study

Exclusion Criteria:

  • Age < 18 year-old
  • Patients with mild AD (SCORAD < 25)
  • Patients without skin lesions in the forearms
  • Patients treated with dermocorticoid or calcineurin inhibitor for less than two weeks
  • Patients under systemic treatment : Methotrexate, Ciclosporin, Mycophenolate Mofetil, Azathioprine, general corticosteroids for less than 4 weeks
  • Patients under biological treatment : Dupilumab for less than 5 half-lives
  • Patient without Social Security
  • Pregnant and nursing women

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): NCT04274348


Contacts
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Contact: Ewa HAINAUT, Dr 05 49 44 45 31 ewa.hainaut@chu-poitiers.fr

Sponsors and Collaborators
Poitiers University Hospital
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT04274348    
Other Study ID Numbers: 2019-A01904-53
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kaposi Varicelliform Eruption
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious