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Completed

NCT Number: NCT04274348

Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Skin biopsies and blood samples

Other

Two skin biopsies and 30 ml of blood will be collected.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: STADEH

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2020
Registry last updated
Dec 29, 2025

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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