Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum

Atopic Dermatitis Clinical Trial

— STADEH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04274348
• Other study ID #: 2019-A01904-53
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: October 16, 2023

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: Ewa HAINAUT, Dr
• Phone: 05 49 44 45 31
• Email: ewa.hainaut[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Bacterial Toxins
• Cytokines
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Immune Response
• Staphylococcus Aureus
• T Cells Subsets

Intervention

Other:
• Skin biopsies and blood samples
Two skin biopsies and 30 ml of blood will be collected.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Biological data obtained from lesional skin will be compared with those of healthy skin.	2 hours (with consultation and sample)