NCT04310189

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

The Role of IL-22/IL-22BP Axis in Atopic Dermatitis. A Cross Sectional Monocentric Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
PROCEDURE	Biopsy	All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2020-03-17
• Last updated: 2022-12-12

Locations

1 site across 1 country: France