Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum

Not Applicable

• Conditions: Cytokines; T Cells Subsets; Staphylococcus Aureus; Bacterial Toxins; Atopic Dermatitis; Immune Response
• Interventions: Other: Skin biopsies and blood samples

• Registration Number: NCT04274348
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Study Start: 2020-10-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin biopsies and blood samples	Skin biopsies and blood samples	-

Primary Outcome Measures

Name	Time	Method
Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions.	2 hours (with consultation and sample)	Biological data obtained from lesional skin will be compared with those of healthy skin.

Secondary Outcome Measures

Name	Time	Method
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)	Biological data obtained from lesional skin will be compared with those of healthy skin.

Trial Locations

Locations (2)

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Poitiers; 🇫🇷 Poitiers, France