Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum

NCT04274348 | Completed

• 1 other identifier: 2019-A01904-53
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Bacterial Toxins; Immune Response; T Cells Subsets; Atopic Dermatitis; Staphylococcus Aureus; Cytokines

Outcome Measures

Primary Outcomes (1)

• Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions.

  Biological data obtained from lesional skin will be compared with those of healthy skin.

  2 hours (with consultation and sample)

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.

  2 hours (with consultation and sample)

Study Arms (1)

Skin biopsies and blood samples

OTHER

Other: Skin biopsies and blood samples

Interventions

Skin biopsies and blood samples OTHER

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

Skin biopsies and blood samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (2)

CHU de Bordeaux

Bordeaux, France

Location

CHU de Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Staphylococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: October 15, 2020
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

FR (2)