MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement

NCT06455891 | Completed

• 2 other identifiers: SGZ-2020-132892024-A00281-46
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Head and neck atopic dermatitis (HNAD); skin mycobiome; Immunity modulation

Outcome Measures

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.

  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.

  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.

  18 months

• Antifungal systemic immune response.

  18 months

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Tenon Hospital APHP dermatology and allergology department

Paris, 75020, France

Location

Related Publications (1)

• 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.

  PMID: 23300406 BACKGROUND

Related Links

• Bibliographic reference

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Angèle SORIA, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: June 12, 2024
• Study Start: May 14, 2024
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

FR (1)