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Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum (STADEH)

Primary Purpose

Atopic Dermatitis, Staphylococcus Aureus, Bacterial Toxins

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Skin biopsies and blood samples
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de BordeauxRecruiting
  • CHU de PoitiersRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Skin biopsies and blood samples

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 14, 2020
Last Updated
January 28, 2021
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04274348
Brief Title
Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum
Acronym
STADEH
Official Title
Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
October 16, 2023 (Anticipated)
Study Completion Date
October 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Staphylococcus Aureus, Bacterial Toxins, Immune Response, Cytokines, T Cells Subsets

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skin biopsies and blood samples
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Skin biopsies and blood samples
Intervention Description
Two skin biopsies and 30 ml of blood will be collected.
Primary Outcome Measure Information:
Title
Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions.
Description
Biological data obtained from lesional skin will be compared with those of healthy skin.
Time Frame
2 hours (with consultation and sample)
Secondary Outcome Measure Information:
Title
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.
Description
Biological data obtained from lesional skin will be compared with those of healthy skin.
Time Frame
2 hours (with consultation and sample)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewa HAINAUT, Dr
Phone
05 49 44 45 31
Email
ewa.hainaut@chu-poitiers.fr
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien SENESCHAL
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa HAINAUT

12. IPD Sharing Statement

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Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum

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