MYCAH

MYCobiome analysis in atopic dermatitis with head and neck involvement

Topic / Pathology

  • observational

Objectives

Perform mycobiome analysis in the head and neck regions of 30 adults with atopic dermatitis compared with 15 healthy controls.

Patients will be classified into 2 subgroups according to the topography and body surface area affected by AD;

Group 1: generalized AD defined by an AD skin lesion affecting more or less 50% of the total body surface, with head and neck involvement (15 patients)
Group 2: DA of the head and neck defined by DA affecting at least 80% of the head and neck with or without DA outside the head and neck but <20% of the total body surface area. (15 patients)
Group 3: Healthy controls without chronic skin disease. Healthy controls will be recruited from non-atopic patients investigated in our departments for drug allergy after resolution of acute events (15 healthy controls).

https://clinicaltrials.gov/study/NCT06455891?term=NCT06455891&ran

Sponsor

APHP

Investigator

Pr Angèle Soria

Critères d'inclusion

  • 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..

Critères de non-inclusion

  • 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 consen

Status

Ongoing

Participating centers

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Updated on 05 February 2025