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Completed

NCT Number: NCT06455891

MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement

It is an open study, explorative, proof of concept study concerning mycobiota dysbiosis implication in AD patients with head and neck involvement.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tenon Hospital APHP dermatology and allergology department

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Study the interaction between mycobiome dysbiosis and immune responses in AD patients with head and neck involvement 1.

  2. Antifungal systemic immune response.

    Time frame: 18 months

    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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: MYCAH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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