STADEH: Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04274348
• Collaborator: (none)
• Enrollment: 80
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site: 40
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis; Staphylococcus Aureus; Bacterial Toxins; Immune Response; Cytokines; T Cells Subsets	Other: Skin biopsies and blood samples	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum
• Actual Study Start Date: Oct 15, 2020
• Anticipated Primary Completion Date: Oct 16, 2023
• Anticipated Study Completion Date: Oct 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Skin biopsies and blood samples	Other: Skin biopsies and blood samples; Two skin biopsies and 30 ml of blood will be collected.

Outcome Measures

Primary Outcome Measures

1. 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

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)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Bordeaux	Bordeaux		France
2	CHU de Poitiers	Poitiers		France

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT04274348
• Other Study ID Numbers: 2019-A01904-53
• First Posted: Feb 18, 2020
• Last Update Posted: Jan 29, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kaposi Varicelliform Eruption; Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Jan 29, 2021