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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04989296
Other study ID # 05912657
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date January 15, 2020

Study information

Verified date July 2021
Source National Medical Research Center for Children's Health, Russian Federation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 15, 2020
Est. primary completion date November 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Peripheral blood samples were obtained following the standard procedures.
Taking 4 ml of peripheral blood from patients on an empty stomach.

Locations

Country Name City State
Russian Federation National Medical Research Center for Children's Health Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Patient age Age assessment from 1 to 18 years old
Primary PASI (Psoriasis Area Severity Index) Change of the PASI 1 day Screening at the time of examination
Primary BSA (Body Surface Area) Assessment of the affected area of the patient's body 1 day Screening at the time of examination
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