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

NCT04989296 | Completed

• 1 other identifier: 05912657
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis Vulgaris

Keywords

NF-κB translocation; Lymphocytes; Flow cytometry with imaging (Amnis); Biological drugs; Сhildren and adolescents

Outcome Measures

Primary Outcomes (4)

• The level of NF-kB translocation in lymphocyte populations

  Changes in NF-kB translocation in lymphocyte populations

  Screening on the 1 day of blood sampling

• Patient age

  Age assessment

  from 1 to 18 years old

• PASI (Psoriasis Area Severity Index)

  Change of the PASI

  1 day Screening at the time of examination

• BSA (Body Surface Area)

  Assessment of the affected area of the patient's body

  1 day Screening at the time of examination

Study Arms (3)

Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group

EXPERIMENTAL

The analysis of the relative count of cells with NF-κB translocation in the lymphocyte populations the group of patients with psoriasis and in the comparison group.

Diagnostic Test: Peripheral blood samples were obtained following the standard procedures.

Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy

EXPERIMENTAL

Determination of the level of NF-kB translocation in lymphocyte populations in patient groups depending on the type of therapy: Group 1 - patients receiving basic and external therapy; Group 2 - patients receiving methotrexate; and Group 3 - patients receiving therapy with biological drugs.

Diagnostic Test: Peripheral blood samples were obtained following the standard procedures.

Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics

EXPERIMENTAL

Assessment of the level of NF-kB translocation in lymphocyte populations, assessment of PASI and BSA, assessment of the effectiveness of biological drugs in patients with psoriasis. Identification of patients in the stage of regression of the disease and in the progressive stage.

Diagnostic Test: Peripheral blood samples were obtained following the standard procedures.

Interventions

Peripheral blood samples were obtained following the standard procedures. DIAGNOSTIC_TEST

Taking 4 ml of peripheral blood from patients on an empty stomach.

Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group; Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy; Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age from 1 to 18 years old
• Mild, moderate, and severe psoriasis
• Healthy children, as a comparison group
• Patients receiving basic and external therapy, receiving systemic therapy with methotrexate and patients receiving therapy with biological drugs (Adalimumab, Etanercept, Ustekinumab)
• A signed and dated informed consent received from the patient's parents (guardians), as well as from a patient over 14 years of age, to participate in the study
• Ability to attend control visits within the specified time frame

You may not qualify if:

• The presence of other concomitant skin diseases in the present or in the past, which could affect the assessment of the effect of the study drugs on the course of psoriasis
• Use of other genetically engineered biological preparations in therapy
• Participation in other clinical trials
• Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out
• Immunodeficiency disease
• The presence in the past or present of any serious and / or unstable concomitant disease
• The course of a viral, bacterial, fungal or parasitic infection

Sponsors & Collaborators

• National Medical Research Center for Children's Health, Russian Federation: lead

Study Sites (1)

National Medical Research Center for Children's Health

Moscow, 119296, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: September 1, 2018
• Primary Completion: November 20, 2019
• Study Completion: January 15, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

RU (1)