VitiligoNCT07298551
Building an Assessment Model for Vitiligo Activity and Prognosis Using Peripheral Blood Cytokine Profiles
An observational study of Vitiligo, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Serum Cytokine Assay
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2025to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital
Xi'an, Shannxi, 710032
Jian Zhe, Associate Professor, 8615332332587, xjzhejian@fmmu.edu.cn
About this study
Official title: Construction of an Assessment Model for Vitiligo Disease Activity and Treatment Prognosis Based on Peripheral Blood Cytokine Profiles
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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- Serum Cytokine Assay
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Cytokine AssayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| healthy people | Not described Receives: 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. Receives: Diagnostic Test: Serum Cytokine Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: "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
Measured: "Baseline""4 week""24 week"
Secondary outcomes (4)
Vitiligo Quality of Life Instrument
Acronym: VitiQoL
Description \& Structure: The VitiQoL is a 15-item, disease-specific quality of life questionnaire designed for patients with vitiligo. It comprises three subdomains: Psychological Burden, Activity Limitation, and Appearance Concerns. Patients are asked to recall their experience over the past week and rate how bothered they have been by each item on a 5-point Likert scale (0 = "Never", 1 = "Rarely", 2 = "Sometimes", 3 = "Often", 4 = "Always").
Scoring Range: The total score ranges from 0 to 60, calculated by summing the scores of all 15 items.
Score Direction \& Interpretation: A higher total score indicates greater impairment in disease-specific quality of life (worse outcome). A decrease in score from baseline represents an improvement.
Measured: "Baseline""4 week""24 week"
Chinese Vitiligo Quality of Life Scale
Acronym: CVQLS
Description: The CVQLS is a 25-item questionnaire developed specifically for Chinese vitiligo patients. It assesses disease impact over the past month across three dimensions: Daily Life Restriction, Disease Burden, and Social Limitation. Items are scored from 0 ("Not at all") to 4 ("Extremely").
Scoring Range: 0 to 100. The total score is the sum of all item scores.
Score Interpretation: A higher score indicates worse quality of life (greater impairment). A decrease in score represents improvement.
Rationale: Selected for cultural relevance to Chinese patients, addressing concerns like economic burden and social stigma not fully captured by international tools.
Measured: "Baseline""4 week""24 week"
Hospital Anxiety and Depression Scale
Acronym: HADS
Description \& Structure: The HADS is a 14-item self-assessment scale designed to screen for states of anxiety and depression in non-psychiatric hospital settings. It consists of two independent subscales: the Anxiety subscale (HADS-A) and the Depression subscale (HADS-D), each containing 7 items. Each item is scored on a 4-point scale (0-3) reflecting the frequency of symptoms over the past week.
Scoring Range:
HADS-Anxiety (HADS-A) subscale score: 0 to 21.
HADS-Depression (HADS-D) subscale score: 0 to 21.
*(Note: A total HADS score [0-42] is not recommended for primary interpretation as it combines distinct constructs.)*
Score Direction \& Interpretation: A higher score on either subscale indicates a greater severity of anxiety or depressive symptoms (worse outcome).
Clinical Cut-off Reference (per subscale): Scores of 0-7 are generally regarded as being in the normal range, 8-10 as borderline/mild, 11-14 as moderate, and 15-21 as severe.
Measured: "Baseline""4 week""24 week"
Serum cytokine concentrations
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
Measured: "Baseline""4 week""24 week"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start23 Dec 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298551
- Sponsor's protocol ID
- XJPF-LCY-V2025113
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of an Assessment Model for Vitiligo Disease Activity and Treatment Prognosis Based on Peripheral Blood Cytokine Profiles
- ClinicalTrials.gov ID
- NCT07298551
- Acronym / sponsor ID
- XJPF-LCY-V2025113
- Conditions
- Vitiligo
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 23 Dec 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 23 Dec 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy people | – | Diagnostic Test: Serum Cytokine Assay |
| vitiligo patients | – | Diagnostic Test: Serum Cytokine AssayVitiligo 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Serum Cytokine AssayDetect 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. | Diagnostic test | healthy people, vitiligo patients |
Primary outcome
Proportion of Patients Achieving T-VASI 50
Time frame: "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
Time frame: "Baseline""4 week""24 week"
The proportion of patients achieving a 75% or greater improvement from baseline in the Facial Vitiligo Area Scoring Index
4 secondary outcomes
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"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo, run by Xijing Hospital at 1 site in China.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Dec 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhe, Associate Professor (8615332332587, xjzhejian@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving T-VASI 50 (time frame: "Baseline""4 week""24 week"). The study lists 2 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 23 Dec 2025.