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Clinical Trials/NCT04274348
NCT04274348CompletedNot Applicable

Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum

Poitiers University Hospital2 sites in 1 country41 target enrollmentStarted: October 15, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
2
Primary Endpoint
Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Skin biopsies and blood samples

Other

Intervention: Skin biopsies and blood samples (Other)

Outcomes

Primary Outcomes

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 Outcomes

  • 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.(2 hours (with consultation and sample))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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