MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
Tenon Hospital APHP dermatology and allergology department
RECRUITING
Paris
Contact Information
Primary
Angèle SORIA, PU-PH
angele.soria@aphp.fr
00 33 156017220
Backup
Delphine Staumont-Salle, PU-PH
Delphine.SALLE@CHRU-LILLE.FR
00 33 320444192
Time Frame
Start Date: 2024-06-16
Estimated Completion Date: 2025-06
Participants
Target number of participants: 45
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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