NCT04989296

Informative Value of Determining the Level of NF-κB Translocation in Lymphocyte Populations in Children With Psoriasis

Informative Value of Determining the Level of NF-κB Translocation by Flow Cytometry With Visualization in Lymphocyte Populations in Children With Psoriasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: National Medical Research Center for Children's Health, Russian Federation · Other Government
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Accepted

Summary

This study is the first to quantify the level of NF-kB translocation in lymphocyte populations in children and adolescents with psoriasis of varying severity.

Detailed description

This is a diagnostic study aimed at finding immunological predictors of the effectiveness of therapy in children and adolescents with psoriasis. The study included 90 patients from 1 to 18 years old with psoriasis vulgaris, mild / moderate and severe. The comparison group consisted of 30 healthy children. The study took into account the PASI (Psoriasis Area Severity Index); the BSA (Body Surface Area); including patient age; duration of the disease; type of therapy; duration of therapy. Depending on the type of therapy, all psoriatic children were divided into 3 groups: Group 1 (n = 24) - patients receiving basic and external therapy; Group 2 (n = 20) - patients receiving systemic therapy with methotrexate; and Group 3 (n = 46) - patients receiving therapy with genetically engineered biological drugs (Adalimumab, Etanercept, Ustekinumab). The analysis of the NF-κB translocation level in lymphocytes was performed by flow cytometry with imaging (Image Stream Mark II - AMNIS) using the Amnis NF-κB Translocation Kit.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Peripheral blood samples were obtained following the standard procedures.	Taking 4 ml of peripheral blood from patients on an empty stomach.

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-11-20
• Completion: 2020-01-15
• First posted: 2021-08-04
• Last updated: 2021-08-04

Locations

1 site across 1 country: Russia