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临床试验/NCT07298551
NCT07298551尚未招募不适用

Construction of an Assessment Model for Vitiligo Disease Activity and Treatment Prognosis Based on Peripheral Blood Cytokine Profiles

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年12月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
125
试验地点
1
主要终点
Proportion of Patients Achieving T-VASI 50

研究概览

简要总结

Vitiligo is a chronic autoimmune disorder characterized by depigmented patches on the skin, which can pose significant psychosocial challenges, particularly for individuals with darker skin tones. Compared to the general population, individuals with vitiligo are more likely to experience immune-mediated diseases or psychological comorbidities. Studies confirm that the combined prevalence of depression and anxiety among vitiligo patients reaches 8% and 35.8%, respectively. Notably, the anxiety prevalence rate is comparable to that seen in other severely debilitating skin conditions such as eczema and psoriasis. However, the progression, stability, and recurrence of vitiligo exhibit high unpredictability. Unlike other inflammatory skin diseases such as psoriasis or atopic dermatitis, there is currently a lack of objective, sensitive biological markers in clinical practice to predict disease activity, forecast treatment response, or assess long-term prognosis. Decisions primarily rely on the attending physician's assessment of disease activity, affected areas, severity, and repigmentation potential. Furthermore, clinical signs of active vitiligo are only observable in some active-phase patients, introducing delays and subjectivity. This leads to reactive treatment decisions, increasing the likelihood of missing the optimal intervention window. Cytokines are small-molecule polypeptides or glycoproteins synthesized and secreted by the body's cells, possessing diverse biological activities. They play a central role in physiological and pathological processes such as immune regulation, anti-infection, and anti-tumor responses. The "Twelve Cytokine Panel" is a clinical test utilizing advanced flow cytometry for the combined analysis of 12 core cytokines. The cytokines included in this test are IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-17, IFN-α, IFN-γ, and TNF-α. This panel comprehensively reflects innate immune and T-cell immune responses, providing crucial laboratory evidence for evaluating the functional status of the immune system and inflammatory network. Cytokines serve as core messenger molecules in the autoimmune pathogenesis of vitiligo, forming a complex inflammatory network that governs the entire process of immune attacks against melanocytes. Consequently, detecting specific cytokine profiles not only deepens our understanding of vitiligo's disease mechanisms but also holds immense potential clinical value in assessing disease activity, monitoring treatment efficacy, and developing novel targeted therapies.

详细描述

Background: Pigmentary skin disorders constitute a group of conditions characterized by the loss of normal pigmentation in the skin and/or mucous membranes. Currently, there is a lack of objective, sensitive biological markers in clinical practice to predict disease activity, forecast treatment response, and assess long-term prognosis. Diagnosis primarily relies on the attending physician's evaluation of disease activity, affected areas, severity, and repigmentation potential. Furthermore, clinical signs of active vitiligo are only observable in some active-phase patients, leading to delayed and subjective assessments. This results in passive treatment decisions and increases the likelihood of missing the optimal intervention window. The "Twelve Cytokine Panel" is a clinical test utilizing advanced flow cytometry for the combined analysis of 12 core cytokines. The cytokines included in this test are Interleukin-1β (IL-1β), Interleukin-2 (IL-2), Interleukin-4 (IL-4), Interleukin-5 (IL-5), Interleukin-6 (IL-6), Interleukin-8 (IL-8, also known as CXCL8), Interleukin-10 (IL-10), Interleukin-12p70 (IL-12p70), Interleukin-17 (IL-17), Interferon-alpha (IFN-α), Interferon-gamma (IFN-γ), and Tumor Necrosis Factor-alpha (TNF-α). This comprehensive assessment reflects innate immune and T-cell immune responses, providing crucial laboratory evidence for evaluating immune system and inflammatory network function. Study Design: Based on this research context, peripheral blood samples were collected from 100 vitiligo patients and 25 healthy controls to measure cytokine levels. The vitiligo patient group was stratified according to clinical treatment modalities. Changes in peripheral blood cytokine levels were tracked at 1-month and 6-month treatment follow-ups, compared against cytokine levels in healthy controls, and correlated with clinical repigmentation status and psychological treatment efficacy. This approach aims to predict vitiligo progression and prognosis through serum inflammatory cytokine levels, thereby enhancing the formulation of clinical treatment strategies. Statistical Methods: Data will undergo statistical inference using chi-square tests, Wilcoxon signed-rank tests, Kruskal-Wallis H tests, Dunn's multiple comparison tests, Pearson correlation analysis, and logistic regression (significance: p ≤ 0.05). Ethics and Compliance: Approved by the Ethics Committee of the First Affiliated Hospital of Air Force Medical University. Informed consent must be obtained from all participants' guardians.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with clinically confirmed vitiligo (diagnosis criteria refer to the Consensus on Vitiligo Diagnosis and Treatment (2018 Edition) established by the Pigment Disorders Group of the Dermatology and Venereology Professional Committee of the Chinese Association of Integrative Medicine) and a healthy control group.
  • Aged 18 years or older, no gender restrictions
  • Possess an elementary school education or higher
  • Voluntarily participate in this study

排除标准

  • Patients who have used antibiotics, corticosteroids, or immunosuppressants within the past month
  • Patients with severe cardiovascular or cerebrovascular disease, severe diabetes, severe infection, or other major illnesses resulting in poor physical condition
  • Patients with photosensitive disorders, skin tumors, autoimmune diseases, or hematological disorders
  • Pregnant or lactating women
  • Patients with poor psychological stability or compliance who cannot cooperate with follow-up visits or nursing care

结局指标

主要结局

Proportion of Patients Achieving T-VASI 50

时间窗: "Baseline""4 week""24 week"

The proportion of patients achieving a 50% or greater improvement from baseline in the Total Vitiligo Area Scoring Index

Proportion of Patients Achieving F-VASI 75

时间窗: "Baseline""4 week""24 week"

The proportion of patients achieving a 75% or greater improvement from baseline in the Facial Vitiligo Area Scoring Index

次要结局

  • Vitiligo Quality of Life Instrument("Baseline""4 week""24 week")
  • Chinese Vitiligo Quality of Life Scale("Baseline""4 week""24 week")
  • Hospital Anxiety and Depression Scale("Baseline""4 week""24 week")
  • Serum cytokine concentrations("Baseline""4 week""24 week")

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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