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

National Medical Research Center for Children's Health, Russian Federation120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

120

Conditions

Psoriasis Vulgaris

Interventions

Peripheral blood samples were obtained following the standard procedures.DIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age from 1 to 18 years old 2. Mild, moderate, and severe psoriasis 3. Healthy children, as a comparison group 4. Patients receiving basic and external therapy, receiving systemic therapy with methotrexate and patients receiving therapy with biological drugs (Adalimumab, Etanercept, Ustekinumab) 5. 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 6. Ability to attend control visits within the specified time frame Exclusion Criteria: 1. 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 2. Use of other genetically engineered biological preparations in therapy 3. Participation in other clinical trials 4. Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out 5. Immunodeficiency disease 6. The presence in the past or present of any serious and / or unstable concomitant disease 7. The course of a viral, bacterial, fungal or parasitic infection

Locations (1)

National Medical Research Center for Children's Health

Moscow, Russia

Outcomes

Primary Outcomes

The level of NF-kB translocation in lymphocyte populations

Changes in NF-kB translocation in lymphocyte populations

Time frame: Screening on the 1 day of blood sampling

Patient age

Age assessment

Time frame: from 1 to 18 years old

PASI (Psoriasis Area Severity Index)

Change of the PASI

Time frame: 1 day Screening at the time of examination

BSA (Body Surface Area)

Assessment of the affected area of the patient's body

Time frame: 1 day Screening at the time of examination

Data from ClinicalTrials.gov

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