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Completed

NCT Number: NCT04989296

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

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.

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Key information

Conditions

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Medical Research Center for Children's Health

Moscow, 119296, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral blood samples were obtained following the standard procedures.

Diagnostic Test

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

Primary outcomes

  1. The level of NF-kB translocation in lymphocyte populations

    Time frame: Screening on the 1 day of blood sampling

    Changes in NF-kB translocation in lymphocyte populations

  2. Patient age

    Time frame: from 1 to 18 years old

    Age assessment

  3. PASI (Psoriasis Area Severity Index)

    Time frame: 1 day Screening at the time of examination

    Change of the PASI

  4. BSA (Body Surface Area)

    Time frame: 1 day Screening at the time of examination

    Assessment of the affected area of the patient's body

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 4, 2021
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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