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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Diagnostic Test: Peripheral blood samples were obtained following the standard procedures.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group<br>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.<br>* Taking 4 ml of peripheral blood from patients on an empty stomach.<br>|
| Experimental: Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy<br>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.<br>* Taking 4 ml of peripheral blood from patients on an empty stomach.<br>|
| Experimental: Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics<br>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.<br>* Taking 4 ml of peripheral blood from patients on an empty stomach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NF-κB translocation, Lymphocytes, Flow cytometry with imaging (Amnis), Biological drugs, Сhildren and adolescents