Psoriasis VulgarisNCT04989296
Informative Value of Determining the Level of NF-κB Translocation in Lymphocyte Populations in Children With Psoriasis
A study testing Peripheral blood samples were obtained following the standard procedures. in people with Psoriasis Vulgaris, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Peripheral blood samples were obtained following the standard procedures.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
National Medical Research Center for Children's Health
Moscow, 119296
About this study
Official title: Informative Value of Determining the Level of NF-κB Translocation by Flow Cytometry With Visualization 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.
Read the 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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Peripheral blood samples were obtained following the standard procedures.
- Keywords
- NF-κB translocation, Lymphocytes, Flow cytometry with imaging (Amnis), Biological drugs, Сhildren and adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood samples were obtained following the standard procedures.Diagnostic test
Taking 4 ml of peripheral blood from patients on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group | Experimental | The analysis of the relative count of cells with NF-κB translocation in the lymphocyte populations the group of patients with psoriasis and in the comparison group. Receives: Diagnostic Test: Peripheral blood samples were obtained following the standard procedures. |
| Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy | Experimental | Determination of the level of NF-kB translocation in lymphocyte populations in patient groups depending on the type of therapy: Group 1 - patients receiving basic and external therapy; Group 2 - patients receiving methotrexate; and Group 3 - patients receiving therapy with biological drugs. Receives: Diagnostic Test: Peripheral blood samples were obtained following the standard procedures. |
| Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics | Experimental | Assessment of the level of NF-kB translocation in lymphocyte populations, assessment of PASI and BSA, assessment of the effectiveness of biological drugs in patients with psoriasis. Identification of patients in the stage of regression of the disease and in the progressive stage. Receives: Diagnostic Test: Peripheral blood samples were obtained following the standard procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of NF-kB translocation in lymphocyte populations
Changes in NF-kB translocation in lymphocyte populations
Measured: Screening on the 1 day of blood sampling
Patient age
Age assessment
Measured: from 1 to 18 years old
PASI (Psoriasis Area Severity Index)
Change of the PASI
Measured: 1 day Screening at the time of examination
BSA (Body Surface Area)
Assessment of the affected area of the patient's body
Measured: 1 day Screening at the time of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Sep 2018
- Primary completion20 Nov 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Children's Health, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989296
- Sponsor's protocol ID
- 05912657
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informative Value of Determining the Level of NF-κB Translocation by Flow Cytometry With Visualization in Lymphocyte Populations in Children With Psoriasis
- ClinicalTrials.gov ID
- NCT04989296
- Acronym / sponsor ID
- 05912657
- Conditions
- Psoriasis Vulgaris
- Keywords
- NF-κB translocation, Lymphocytes, Flow cytometry with imaging (Amnis), Biological drugs, Сhildren and adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Medical Research Center for Children's Health, Russian FederationOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group | Experimental | Diagnostic Test: Peripheral blood samples were obtained following the standard procedures.The analysis of the relative count of cells with NF-κB translocation in the lymphocyte populations the group of patients with psoriasis and in the comparison group. |
| Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy | Experimental | Diagnostic Test: Peripheral blood samples were obtained following the standard procedures.Determination of the level of NF-kB translocation in lymphocyte populations in patient groups depending on the type of therapy: Group 1 - patients receiving basic and external therapy; Group 2 - patients receiving methotrexate; and Group 3 - patients receiving therapy with biological drugs. |
| Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics | Experimental | Diagnostic Test: Peripheral blood samples were obtained following the standard procedures.Assessment of the level of NF-kB translocation in lymphocyte populations, assessment of PASI and BSA, assessment of the effectiveness of biological drugs in patients with psoriasis. Identification of patients in the stage of regression of the disease and in the progressive stage. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood samples were obtained following the standard procedures.Taking 4 ml of peripheral blood from patients on an empty stomach. | Diagnostic test | Level of NF-κB translocation in lymphocyte in children with psoriasis and in comparison group, Level of NF-κB translocation in lymphocyte in children with psoriasis, based on the type of therapy, Severity of psoriasis based on level of NF-κB translocation in psoriasis who received biologics |
Primary outcome
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
Patient age
Time frame: from 1 to 18 years old
Age assessment
PASI (Psoriasis Area Severity Index)
Time frame: 1 day Screening at the time of examination
Change of the PASI
BSA (Body Surface Area)
Time frame: 1 day Screening at the time of examination
Assessment of the affected area of the patient's body
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral blood samples were obtained following the standard procedures. in people with Psoriasis Vulgaris, run by National Medical Research Center for Children's Health, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of NF-kB translocation in lymphocyte populations (time frame: Screening on the 1 day of blood sampling). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.