The Role of IL-22/IL-22BP Axis in Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Jun 2, 2022
  • participants needed
    45
  • sponsor
    Nantes University Hospital
Updated on 27 January 2021

Summary

Interleukin 22 (IL-22) is known to be regulated by IL-22 binding protein (IL-22BP), a soluble, inhibitory receptor. The potential role of IL-22BP in atopic dermatitis (AD) is mostly unknown and deserves further investigation. The main objective of this study is to better understand the potential protective role of IL-22BP through the assessment of its expression at the Messenger Ribonucleic Acid (mRNA) and protein levels in skin and serum which will be correlated to the severity of the diseases and through the identification of its cellular sources in lesions. The results of this study will help to correctly interpret the levels of IL-22 in AD and will potentially allow identifying biomarkers for patient stratification and predicting clinical outcomes to targeted therapeutic agents.

Description

This is a single-visit study. All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area

. It is planned to include 45 patients (15 patients per severity group: SCORAD ]25-50] , ]50-65]; 50-65; >65).The first 20 patients included will be group 2 and 3 patients (SCORAD > 50).

The patients will be adults with AD recruited from the cohort of patients followed up in the Dermatology department of Nantes University Hospital. A refusal rate of 4/5 is expected. Recruitment can therefore be envisaged in 18 months (2.5 patients/month). Patients will be recruited during follow-up consultations or at the first consultation in the department. Recruitment will be coordinated by the clinical research team (CRT). Blood samples will be taken by the CRT Nurse. The skin and blood samples will be sent to the CIMNA/ Immunology Laboratory Nantes University hospital

Details
Condition Eczema, Eczema (Atopic Dermatitis - Pediatric), ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), ATOPIC DERMATITIS, Dermatitis, Atopic, Dermatite Atopique, Eczéma (Dermatite Atopique), Dermatitis, Hand Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Eczéma (Dermatite Atopique), Dermatite Atopique
Treatment biopsy
Clinical Study IdentifierNCT04310189
SponsorNantes University Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with AD according to UK Working Party criteria
Patients affiliated to French social security system
Patients who gave written consent after reading the protocol
Moderate to severe AD (SCORAD score>25)
Presence of at least one lesional and one non-lesional skin area in the area covered by the clothing
No immunosuppressive systemic treatment in progress for at least 3 months or biologics for at least 4 months

Exclusion Criteria

Minor patients
Pregnant and/or breastfeeding women
Patients under guardianship or tutorship
Inability to understand information and instructions
Patients undergoing systemic immunosuppressive treatment for at least 3 months or biologics for at least 4 months
Patient included in a clinical trial
Documented allergy to the anesthetic (xylocain)
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