Atopic DermatitisMYCAHNCT06455891
MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement
An observational study of Atopic Dermatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
It is an open study, explorative, proof of concept study concerning mycobiota dysbiosis implication in AD patients with head and neck involvement. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2024to 17 Dec 2025
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult, age between 18 and 65 years with generalized and head and neck AD treated with topical steroids and/or topical tacrolimus for AD.
Who may be able to join
- Age between 18 and 65 years;
- Male or female;
- The diagnosis of atopic dermatitis (AD) is defined according to the criteria of UK Working Party with at least 3 of the following 5 criteria are present; history of flexural involvement, history of a dry skin, onset under the age of 2, personal history of asthma or allergic rhinitis, history of a pruritic skin condition, and visible flexural dermatitis.
- Generalized AD defined by AD involved ≥50% of total body surface area with head and neck involvement. Or HNAD defined by AD involving at least 80% of the head and neck area with or without AD involvement outside the head and neck area but <20% of total body surface area.
- With or without topical anti-inflammatory treatments for AD (including; topical steroids and/or topical tacrolimus)
- Free, informed and written consent, signed by the patient and the investigator before any examination required by the trial;
- Affiliation to social security scheme (beneficiary or assignee)
- Healthy control are the same age and sex.
Who cannot join
- Systemic or local antifungal therapy within 2 months before entry and during the study
- Systemic treatments for AD; including: ciclosporine, dupilumab and others AD biologics, methotrexate, JAK-inhibitors
- Current participation in another interventional research
- Patient with a measure of legal protection
- Psychiatric illness or any other concomitant chronic illness or addiction that could be interfere with the ability to meet the requirements of the protocol or provide informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Tenon Hospital APHP dermatology and allergology department
Paris, 75020
About this study
It is an open study, explorative, proof of concept study concerning mycobiota dysbiosis implication in AD patients with head and neck involvement.
Read the detailed description
The aim of this study is to carry out an analysis of the mycobiome in the head and neck regions of 30 adults with Atopic dermatitis compared with 15 healthy controls.
patients and participants will be recruited from 2 centers Hôpital Tenon AP-HP (Pr A Soria) and CHU Lille (Pr D Staumont-Sallé) over a 12-month period.
Patient will be classified in 2 subgroups according to topography and body surface area involved by AD;
- Group 1: Generalized AD defined by AD skin lesion involved more or equal 50% of total body surface area with head and neck involvement. (15 patients)
- Group 2: Head and neck AD (HNAD) defined by AD involving at least 80% of the head and neck area with or without AD involvement outside the head and neck area but <20% of total body surface area. (15 patients) Group 3: Healthy control without chronic skin disease. Healthy control will be recruited from non-atopic patients explored in ours departments for drug allergy after resolution of acute events. (15 healthy controls) In the framework of consultation, medical examination with clinical assessment, non-invasive skin microbiota samples (3x2 skin ESwab) will be performed and a supplemental blood sample was collected (35 mL) for study of innate and adaptive immune response (see Diagram of the study summarising the chronology of the study). For each patient the end of participation in the study is achieved after the completion of swab and blood samples. No follow up is planned. Patients' participation is 1 day at maximum.
Skin samples will be used for study of Mycobiome by culture and MALDI-TOF and NGS analysis and Blood sample will be used for study of the immune innate and adaptative response.
- Conditions
- Atopic Dermatitis
- Keywords
- Head and neck atopic dermatitis (HNAD), skin mycobiome, Immunity modulation
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with generalized AD defined by AD skin lesion involved more or equal 50% of total body surface area with head and neck involvement. (15 patients) | |
| Group 2 | Patients with head and neck AD (HNAD) defined by AD involving at least 80% of the head and neck area with or without AD involvement outside the head and neck area but <20% of total body surface area. (15 patients) | |
| Group 3 | Healthy control without chronic skin disease. Healthy control will be recruited from non-atopic patients explored in ours departments for drug allergy after resolution of acute events. (15 healthy controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description and comparison of head and neck mycobiome in AD patients, with generalized AD and HNAD, compared to head and neck mycobiome in controls.
To conduct a mycobiome analysis in the Head and Neck areas in adults with AD compared to healthy control using matrix-assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF) after culture. An additional analysis of the mycobiome by next generation sequencing (NGS) will also be carried out.
Measured: 18 months
Secondary outcomes (2)
Lectins and gene polymorphism implicated in innate response to mycobiome in AD patients with head and neck involvement. 15 mL of blood will be collected.
Study the interaction between mycobiome dysbiosis and immune responses in AD patients with head and neck involvement 1.
Measured: 18 months
Antifungal systemic immune response.
20 mL of blood will be collected for specific Ig A, G, M and E detection and analysis of adaptive immune response against the predominant fungi identified in mycobiome of AD patients with head and neck involvement in order to study the interaction between mycobiome dysbiosis and immune responses in AD patients with head and neck involvement 2
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start14 May 2024
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angèle SORIA, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455891
- Sponsor's protocol ID
- SGZ-2020-13289
- Other IDs
- 2024-A00281-46
- Acronym
- MYCAH
- Status last verified
- Mar 2026
- First submitted
- 7 May 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morgan XC, Huttenhower C. Chapter 12: Human microbiome analysis. PLoS Comput Biol. 2012;8(12):e1002808. doi: 10.1371/journal.pcbi.1002808. Epub 2012 Dec 27.
PubMed 23300406
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement
- ClinicalTrials.gov ID
- NCT06455891
- Acronym / sponsor ID
- MYCAH / SGZ-2020-13289
- Conditions
- Atopic Dermatitis
- Keywords
- Head and neck atopic dermatitis (HNAD), skin mycobiome, Immunity modulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 12 Jun 2024 (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.
It is an open study, explorative, proof of concept study concerning mycobiota dysbiosis implication in AD patients with head and neck involvement.
Detailed description
The aim of this study is to carry out an analysis of the mycobiome in the head and neck regions of 30 adults with Atopic dermatitis compared with 15 healthy controls.
patients and participants will be recruited from 2 centers Hôpital Tenon AP-HP (Pr A Soria) and CHU Lille (Pr D Staumont-Sallé) over a 12-month period.
Patient will be classified in 2 subgroups according to topography and body surface area involved by AD;
- Group 1: Generalized AD defined by AD skin lesion involved more or equal 50% of total body surface area with head and neck involvement. (15 patients)
- Group 2: Head and neck AD (HNAD) defined by AD involving at least 80% of the head and neck area with or without AD involvement outside the head and neck area but <20% of total body surface area. (15 patients) Group 3: Healthy control without chronic skin disease. Healthy control will be recruited from non-atopic patients explored in ours departments for drug allergy after resolution of acute events. (15 healthy controls) In the framework of consultation, medical examination with clinical assessment, non-invasive skin microbiota samples (3x2 skin ESwab) will be performed and a supplemental blood sample was collected (35 mL) for study of innate and adaptive immune response (see Diagram of the study summarising the chronology of the study). For each patient the end of participation in the study is achieved after the completion of swab and blood samples. No follow up is planned. Patients' participation is 1 day at maximum.
Skin samples will be used for study of Mycobiome by culture and MALDI-TOF and NGS analysis and Blood sample will be used for study of the immune innate and adaptative response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with generalized AD defined by AD skin lesion involved more or equal 50% of total body surface area with head and neck involvement. (15 patients) |
| Group 2 | – | –Patients with head and neck AD (HNAD) defined by AD involving at least 80% of the head and neck area with or without AD involvement outside the head and neck area but <20% of total body surface area. (15 patients) |
| Group 3 | – | –Healthy control without chronic skin disease. Healthy control will be recruited from non-atopic patients explored in ours departments for drug allergy after resolution of acute events. (15 healthy controls) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, age between 18 and 65 years with generalized and head and neck AD treated with topical steroids and/or topical tacrolimus for AD.
Key inclusion criteria (8 listed)
- Age between 18 and 65 years;
- Male or female;
- The diagnosis of atopic dermatitis (AD) is defined according to the criteria of UK Working Party with at least 3 of the following 5 criteria are present; history of flexural involvement, history of a dry skin, onset under the age of 2, personal history of asthma or allergic rhinitis, history of a pruritic skin condition, and visible flexural dermatitis.
- Generalized AD defined by AD involved ≥50% of total body surface area with head and neck involvement. Or HNAD defined by AD involving at least 80% of the head and neck area with or without AD involvement outside the head and neck area but <20% of total body surface area.
- With or without topical anti-inflammatory treatments for AD (including; topical steroids and/or topical tacrolimus)
Key exclusion criteria (5 listed)
- Systemic or local antifungal therapy within 2 months before entry and during the study
- Systemic treatments for AD; including: ciclosporine, dupilumab and others AD biologics, methotrexate, JAK-inhibitors
- Current participation in another interventional research
- Patient with a measure of legal protection
- Psychiatric illness or any other concomitant chronic illness or addiction that could be interfere with the ability to meet the requirements of the protocol or provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description and comparison of head and neck mycobiome in AD patients, with generalized AD and HNAD, compared to head and neck mycobiome in controls.
Time frame: 18 months
To conduct a mycobiome analysis in the Head and Neck areas in adults with AD compared to healthy control using matrix-assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF) after culture. An additional analysis of the mycobiome by next generation sequencing (NGS) will also be carried out.
2 secondary outcomes
Lectins and gene polymorphism implicated in innate response to mycobiome in AD patients with head and neck involvement. 15 mL of blood will be collected.
Time frame: 18 months
Antifungal systemic immune response.
Time frame: 18 months
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 11 Mar 2026.
- Background: PubMed 23300406Morgan XC, Huttenhower C. Chapter 12: Human microbiome analysis. PLoS Comput Biol. 2012;8(12):e1002808. doi: 10.1371/journal.pcbi.1002808. Epub 2012 Dec 27.
- Bibliographic referenceLink provided by the sponsor.
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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.
Angèle SORIA, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 8 inclusion and 5 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Description and comparison of head and neck mycobiome in AD patients, with generalized AD and HNAD, compared to head and neck mycobiome in controls. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06455891, which also lists 1 linked publication.
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 11 Mar 2026.