Psoriasis Vulgaris
Conditions
Keywords
NF-κB translocation, Lymphocytes, Flow cytometry with imaging (Amnis), Biological drugs, Сhildren and adolescents
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.
Interventions
DIAGNOSTIC_TESTPeripheral blood samples were obtained following the standard procedures.
Taking 4 ml of peripheral blood from patients on an empty stomach.
Sponsors
National Medical Research Center for Children's Health, Russian Federation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The level of NF-kB translocation in lymphocyte populations | Screening on the 1 day of blood sampling | Changes in NF-kB translocation in lymphocyte populations |
| Patient age | from 1 to 18 years old | Age assessment |
| PASI (Psoriasis Area Severity Index) | 1 day Screening at the time of examination | Change of the PASI |
| BSA (Body Surface Area) | 1 day Screening at the time of examination | Assessment of the affected area of the patient's body |
Countries
Russia
Outcome results
None listed