Analysis of skin fungi in patients with atopic dermatitis affecting the head and neck

MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement

This study looks at the skin fungi in adults with atopic dermatitis on their head and neck to see how it differs from healthy people.

Quick facts

• Study type: Observational
• Enrollment: 45 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Drugs / interventions: dupilumab, methotrexate
• Locations: 1 site (Paris)
• Trial ID: NCT06455891 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the role of mycobiota dysbiosis in adults with atopic dermatitis (AD) that involves the head and neck. It will analyze skin samples from 30 AD patients and compare them to 15 healthy controls to understand the differences in skin fungi. Participants will be classified into two groups based on the extent of their skin involvement, and non-invasive skin microbiota samples will be collected alongside blood samples to assess immune responses. The study will take place over a 12-month period at two centers in France.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with atopic dermatitis affecting the head and neck region.

Not a fit: Patients with atopic dermatitis not involving the head and neck or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the skin microbiome's role in atopic dermatitis, potentially leading to improved treatments.

How similar studies have performed: While studies on skin microbiota in atopic dermatitis exist, this specific focus on head and neck involvement is relatively novel.

Eligibility criteria

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

Where this trial is running

Paris

• Tenon Hospital APHP dermatology and allergology department — Paris, France (Recruiting)

Study contacts

• Principal investigator: Angèle SORIA, PU-PH — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Angèle SORIA, PU-PH

Conditions Atopic Dermatitis; Head and neck atopic dermatitis; skin mycobiome; Immunity modulation