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

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989296
• Other study ID #: 05912657
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

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