MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-16

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Microbiome in Atopic Dermatitis Under Systemic Therapy

NCT05099315

Atopic Dermatitis

RECRUITING

A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.

NCT05689151

Atopic Dermatitis Eczema

RECRUITING

Assessment of Clinical, Biological and Biometrological Parameters in Adults Subjects With Atopic Dermatitis

NCT07017348

Atopic Dermatitis Healthy

COMPLETED NA

Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

NCT05990725

Atopic Dermatitis Eczema

ACTIVE_NOT_RECRUITING PHASE3

Staphylococcus Aureus in Atopic Dermatitis Immunopathology

NCT04715087

Atopic Dermatitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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
* Generalized AD without head and neck involvement
* AD involved less than 50% of total body surface
* Head and neck AD with less than 80% of the head and neck area involved
* Head and neck AD with more than 20% of AD involvement outside the head and neck area
* Current participation in another biomedical 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes