Informative Value of Determining the Level of NF-κB Translocation by Flow Cytometry With Visualization in Lymphocyte Populations in Children With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Patient age
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient age
时间窗: from 1 to 18 years old
Age assessment
The level of NF-kB translocation in lymphocyte populations
时间窗: Screening on the 1 day of blood sampling
Changes in NF-kB translocation in lymphocyte populations
PASI (Psoriasis Area Severity Index)
时间窗: 1 day Screening at the time of examination
Change of the PASI
BSA (Body Surface Area)
时间窗: 1 day Screening at the time of examination
Assessment of the affected area of the patient's body
次要结局
未报告次要终点