Building an Assessment Model for Vitiligo Activity and Prognosis Using Peripheral Blood Cytokine Profiles

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Diagnostic test Serum Cytokine Assay
  Detect the expression levels of cytokines including 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 in peripheral blood.

Primary outcome measures

• Proportion of Patients Achieving T-VASI 50 [Time frame: "Baseline""4 week""24 week"]
• Proportion of Patients Achieving F-VASI 75 [Time frame: "Baseline""4 week""24 week"]

Secondary outcome measures (4)

• Vitiligo Quality of Life Instrument [Time frame: "Baseline""4 week""24 week"]
• Chinese Vitiligo Quality of Life Scale [Time frame: "Baseline""4 week""24 week"]
• Hospital Anxiety and Depression Scale [Time frame: "Baseline""4 week""24 week"]
• Serum cytokine concentrations [Time frame: "Baseline""4 week""24 week"]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

• Xijing Hospital — Xi'an

Identifiers

NCT: NCT07298551 · XJPF-LCY-V2025113

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗