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

NCT07298551 | Not Yet Recruiting DMC

• 1 other identifier: XJPF-LCY-V2025113
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients Achieving T-VASI 50

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

  "Baseline""4 week""24 week"

• Proportion of Patients Achieving F-VASI 75

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

  "Baseline""4 week""24 week"

Secondary Outcomes (4)

• 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"

Study Arms (2)

healthy people

Diagnostic Test: Serum Cytokine Assay

vitiligo patients

Vitiligo patients were assigned to one of the following treatment groups based on clinical protocols: topical therapy group, systemic therapy group, phototherapy group, or combination therapy group.

Diagnostic Test: Serum Cytokine Assay

Interventions

Serum Cytokine Assay DIAGNOSTIC_TEST

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.

healthy people; vitiligo patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult participants aged 18 or older, divided into a case group of clinically confirmed vitiligo patients and a healthy control group, all possessing at least an elementary school education and voluntarily participating. Excluded are individuals who have recently used antibiotics, corticosteroids, or immunosuppressants; those with significant comorbidities such as severe cardiovascular disease, diabetes, infections, photosensitive disorders, skin tumors, autoimmune or hematological diseases; pregnant or lactating women; and those with psychological or compliance issues that would hinder follow-up or care cooperation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shannxi, 710032, China

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jian Zhe, Associate Professor

CONTACT

8615332332587; xjzhejian@fmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 23, 2025
• Study Start: December 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CN (1)