Clinical trial NCT04989296: Informative Value of Determining the Level of NF-κB Translocation in Lymphocyte Populations in Children With Psoriasis
Official title: Informative Value of Determining the Level of NF-κB Translocation by Flow Cytometry With Visualization in Lymphocyte Populations in Children With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Keywords: NF-κB translocation
Lymphocytes
Flow cytometry with imaging (Amnis)
Biological drugs
Сhildren and adolescents
Lead sponsor: National Medical Research Center for Children's Health, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2021-08-04
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The level of NF-kB translocation in lymphocyte populations
timeFrame: Screening on the 1 day of blood sampling
measure: Patient age
timeFrame: from 1 to 18 years old
measure: PASI (Psoriasis Area Severity Index)
timeFrame: 1 day Screening at the time of examination
measure: BSA (Body Surface Area)
timeFrame: 1 day Screening at the time of examination
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Children's Health
Study officials:
References: