The Role of IL-22/IL-22BP Axis in Atopic Dermatitis. A Cross Sectional Monocentric Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nantes University Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Expression levels of IL-22 at the transcriptomic level
Study Overview
Brief 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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Expression levels of IL-22 at the transcriptomic level
Time Frame: 1 day
To compare the expression levels of IL-22 at the transcriptomic level in non lesional and lesional skin between the different groups of AD patients included in the study. Three groups of patients will be defined based on the SCORAD score . The score is out of 103 and is higher the greater the severity of the disease: * Group 1: SCORAD score between \]25-50\] * Group 2: SCORAD between \]50; 65\] * Group 3: SCORAD greater than 65.
Secondary Outcomes
- IL-22 expression levels in lesional skin at the protein level(1 day)
- level of IL22BP gene expression in in lesional and non lesional(1 day)
- The level of IL-22-induced gene expression in lesional and non-lesional skin(1 day)
- Locating IL-22 Binding protein (BP)(1 day)
- Characterizing IL-22 Binding protein (BP)(1 day)
- expression levels of IL-22BP at the transcriptome level in in lesional skin(1 day)
- expression levels of IL-22BP at the protein level in lesional(1 day)
- level of IL22R gene expression in lesional skin(1 day)
- Level of IL-22BP and IL-22 proteins in serum(1 day)
- level of IL22 gene expression in lesional and non lesional skin(1 day)
- the level of IL22 receptor (IL22R ) gene expression in in lesional and non lesional skin(1 day)
- The level of expression of the following IL-22-induced genes(1 day)