Atopic DermatitisSTADEHNCT04274348
Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum
A study testing Skin biopsies and blood samples in people with Atopic Dermatitis and Staphylococcus Aureus, run by Poitiers University Hospital at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Staphylococcus Aureus, Bacterial Toxins
- What is being tested?
- Skin biopsies and blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Oct 2020to 4 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum
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
- Atopic Dermatitis, Staphylococcus Aureus, Bacterial Toxins, Immune Response, Cytokines, T Cells Subsets
- Being tested
- Skin biopsies and blood samples
- Medical subject headings
- Dermatitis, Atopic, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsies and blood samplesOther
Two skin biopsies and 30 ml of blood will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Skin biopsies and blood samples | Other | Not described Receives: Other: Skin biopsies and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Biological data obtained from lesional skin will be compared with those of healthy skin.
Measured: 2 hours (with consultation and sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start15 Oct 2020
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274348
- Sponsor's protocol ID
- 2019-A01904-53
- Acronym
- STADEH
- Status last verified
- Dec 2025
- First submitted
- 14 Feb 2020
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Staphylococci on Cytokine and T Cell Profiles in the Pathogenesis of Atopic Dermatitis and Eczema Herpeticum
- ClinicalTrials.gov ID
- NCT04274348
- Acronym / sponsor ID
- STADEH / 2019-A01904-53
- Conditions
- Atopic Dermatitis, Staphylococcus Aureus, Bacterial Toxins, Immune Response, Cytokines, T Cells Subsets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin biopsies and blood samples | Other | Other: Skin biopsies and blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsies and blood samplesTwo skin biopsies and 30 ml of blood will be collected. | Other | Skin biopsies and blood samples |
Primary outcome
Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions.
Time frame: 2 hours (with consultation and sample)
Biological data obtained from lesional skin will be compared with those of healthy skin.
1 secondary outcome
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.
Time frame: 2 hours (with consultation and sample)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsies and blood samples in people with Atopic Dermatitis and Staphylococcus Aureus, run by Poitiers University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of S. aureus colonization level and characterization of bacterial virulence profile in AD lesions. (time frame: 2 hours (with consultation and sample)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.