VitiligoNCT07307534
Nevus Removal vs. Conservative Treatment in Halo Nevus With Vitiligo: A Randomized Study
A study testing Central Nevus Excision and The Standardized Medication Regimen in people with Vitiligo and Halo Nevus, run by Xijing Hospital at 1 site in China.
Trial summary
This clinical trial aims to compare the efficacy and safety of central nevus removal versus conservative treatment in patients with halo nevus accompanied by non-segmental vitiligo. Read more about this study
- Who is it for?
- Ages 6 to 45 years
- Conditions the study is for
- Vitiligo, Halo Nevus
- What is being tested?
- Central Nevus Excision and The Standardized Medication Regimen
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 1 Oct 2027
- Phase
- Interventional
- 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 6 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with halo nevus accompanied by non-segmental vitiligo, with BSA ≤2% (excluding acral regions).
- Central nevus confirmed as benign melanocytic nevus through clinical observation and dermatoscope.
- Age 6 to 45 years, regardless of gender ④ Physically able to tolerate surgery and local anesthesia
Who cannot join
- History of keloid formation or hypertrophic scarring (to avoid abnormal hyperplasia at the operative site and interference with repigmentation assessment)
- Other autoimmune diseases (e.g., hyperthyroidism)
- Patients with significant endocrine disorders, psychiatric conditions, hematologic diseases, hepatic/renal disorders, cardiovascular/cerebrovascular diseases, severe infections, or other major systemic illnesses
- Use of hormonal medications, immunomodulators, or phototherapy within the past 1 month ⑤ Pregnant or lactating women ⑥ Allergy to anesthetic agents or excipients
- Poor psychological status or compliance, unable to cooperate with postoperative follow-up or care ⑧ Concurrent conditions requiring other treatments that may interfere with the study observations
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, Shaanxi, 710032
Zhe Jian, 8615332332587, xjzhejian@fmmu.edu.cn
About this study
Official title: Central Nevus Removal Versus Conservative Treatment for Halo Nevus With Vitiligo: A Prospective Randomized Controlled Trial
This clinical trial aims to compare the efficacy and safety of central nevus removal versus conservative treatment in patients with halo nevus accompanied by non-segmental vitiligo. It is a single-center, prospective, randomized controlled trial involving 60 participants aged 6 to 45 years, who will be randomly assigned to either the nevus removal group or the conservative treatment group. The removal group will undergo surgical or laser excision of the central nevus followed by medication, while the conservative group will receive medication only. Both groups will be followed for 6 months. Outcomes include repigmentation assessment using vitiligo scoring indices, quality of life measures, and serial serum cytokine profiling. The study seeks to provide high-level evidence to guide clinical management of halo nevus with vitiligo. Key points:
- For patients with halo nevus accompanied by non-segmental vitiligo.
- For patients aged 6 to 45 years.
- Compares nevus excision and conservative treatment.
- Follows participants for 6 months.
- Focuses on effectiveness and safety.
Read the detailed description
Background:
Halo nevus and vitiligo are both autoimmune pigment loss disorders that frequently co-occur and share overlapping immune pathways. Current management of halo nevus with vitiligo remains controversial: removal of the central nevus may eliminate an immune target and promote repigmentation but carries risks of Koebner phenomenon and scarring; conservative treatment avoids procedural trauma but may yield slower or suboptimal responses. Robust prospective comparisons of these strategies are lacking.
- Study Design: Single-center, randomized controlled trial. Sixty patients with halo nevus and non-segmental vitiligo (BSA ≤2%) will be randomized 1:1 to the excision group or the conservative group.
- Excision group: Central nevus removal via CO₂ laser (if diameter <0.3 cm) or surgical excision (if ≥0.3 cm), followed by standardized medication after 1 week.
- Conservative group: Standardized medication only, without nevus removal. The standardized medication regimen is as follows: For stable disease, apply topical 0.1% tacrolimus ointment twice daily combined with NB-UVB phototherapy once every other day. For active or progressive cases, oral prednisone (prednisone acetate, 0.3 mg/kg/day) is added to the above stable-stage regimen.
- Duration: 6 months with follow-ups at 1, 3, 6 months.
- Outcome Measures: Primary Endpoint: Percentage of participants achieving VASl50 response Secondary Endpoints: Percentage of participants achieving VASI75 and VASI90 responses at each follow-up time point; changes in VASI, VSAS, VES, VETF scores; proportion of participants achieving lGA score improvement; patient-reported outcomes (DLQI/CDLQI, VitiQoL); incidence of treatment-emergent adverse events Other Pre-specified Outcomes: Changes in 12 serum cytokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-17, IFN-α, IFN-γ, TNF-α).
- Statistical Methods: Categorical data will be presented as frequencies and percentages, continuous data as mean ± SD. Between-group comparisons will use chi-square tests, Fisher's exact test, independent t-test, or Mann-Whitney U test as appropriate. Multivariate analysis will employ logistic regression. SPSS, R 4.3.2, and GraphPad Prism will be used for analysis (significance: p ≤ 0.05). The primary and secondary efficacy endpoints will be analyzed using the intention-to-treat (ITT) principle, with sensitivity analysis performed on the per-protocol (PP) population.
- Ethics \& Compliance: Approved by the Ethics Committee of the First Affiliated Hospital of Air Force Medical University. Informed consent is obtained from all participants' guardians.
- Significance: This trial will systematically evaluate the clinical and immunological effects of central nevus removal versus conservative management in halo nevus with vitiligo, aiming to optimize treatment strategies and provide evidence-based guidance for clinicians.
- Conditions
- Vitiligo, Halo Nevus
- Being tested
- Central Nevus Excision, The Standardized Medication Regimen
- Keywords
- Vitiligo, Halo nevus, Randomized Controlled Trial, Tacrolimus, NB-UVB, Nevus excision, Treatment comparison, Efficacy, Safety, VASI score
- Medical subject headings
- Vitiligo, Nevus, Halo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Nevus ExcisionProcedure or surgery
Participants undergo removal of the central halo nevus based on its diameter:
Diameter <0.3 cm: CO₂ laser ablation. Diameter ≥0.3 cm: Surgical excision. All procedures are performed under local anesthesia with strict aseptic technique. Postoperative care and wound management are provided according to standard protocols.
The Standardized Medication RegimenCombination product
For stable disease, apply topical 0.1% tacrolimus ointment twice daily combined with NB-UVB phototherapy once every other day.
For active or progressive cases, oral prednisone (prednisone acetate, 0.3 mg/kg/day) is added to the above stable-stage regimen.
| Study group | Role | What they receive |
|---|---|---|
| Central Nevus Excision Group | Experimental | Participants in this arm undergo surgical or laser excision of the central nevus, with standardized medication initiated one week postoperatively. Receives: Procedure: Central Nevus Excision; Combination Product: The Standardized Medication Regimen |
| Conservative Treatment Group | Active comparator | Participants in this arm receive standardized medication only without nevus removal. Receives: Combination Product: The Standardized Medication Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving VASl50 Response
VASl (Vitiligo Area and Severity lndex) 50 response is defined as a 50% or greater reduction in VASl score from baseline. Assessment is conducted by trained dermatologists using standardized VASl scoring criteria.
Measured: From enrollment to the end of treatment at 6 months.
Secondary outcomes (9)
Percentage of Participants Achieving VASI75 and VASI90 responses at each follow-up time point
VASl75 (or VASI90) response is defined as a 75% (or 90%) or greater reduction in VASl score from baseline. Assessment is conducted by trained dermatologists using standardized VASl scoring criteria.
Measured: From enrollment to the end of treatment at 6 months.
Change in Vitiligo Area and Severity Index (VASl) Score
Calculate the difference between the VASl score at 6 months and the baseline VASl score, including the mean percentage change in VASI from baseline at 6 months. This reflects the improvement vitiligo area and severity over the treatment period.
Measured: From enrollment to the end of treatment at 6 months.
Change in Vitiligo Signs of Activity Score (VSAS) Score
Calculate the difference between the VSAS score at 6 months and the baseline VSAS score.
Measured: From enrollment to the end of treatment at 6 months.
Change in Vitiligo Extent Score (VES) Score
Calculate the difference between the VES score at 6 months and the baseline VES score.
Measured: From enrollment to the end of treatment at 6 months.
Change in Vitiligo European Task Force (VETF) Score
Calculate the difference between the VETF score at 6 months and the baseline VETF score.
Measured: From enrollment to the end of treatment at 6 months.
Change in Dermatology life quality index (DLQI) Score
Description \& Structure: Dermatology Life Quality Index (DLQI) is a 10-item, disease-specific quality of life questionnaire designed for adults with skin conditions. It assesses the impact of skin disease across three domains: Physical, Social, and Psychological impacts. Children Dermatology life quality index (CDLQI) is the children's version of the DLQI, which is suitable for children aged 5 to 16 years. For young children, parental assistance or proxy completion is recommended.
Scoring Range: Each item is rated on a 4-point Likert scale (0 = "Not at all", 1 = "A little", 2 = "Quite a lot", 3 = "Very much"). The total score is the sum of all 10 items, ranging from 0 to 30.
Score Direction \& Interpretation: A higher total score indicates a greater negative impact on the child's disease-specific quality of life (a worse outcome). A decrease in the score from baseline represents an improvement in quality of life.
Measured: From enrollment to the end of treatment at 6 months.
Change in The Vitiligo-specific Quality-of-Life instrument (VitiQoL) Score
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: From enrollment to the end of treatment at 6 months.
Proportion of Participants Achieving investigator Global Assessment (lGA) Score lmprovement
Assess participants' lGA scores at 24 weeks. Participants with an lGA score of "mild" or better (score s 2) are defined as achieving improvement, and the proportion is calculated.
Measured: From enrollment to the end of treatment at 6 months.
Incidence of Treatment-Emergent Adverse Events
All surgery-related and disease-related adverse events, such as localized erythema, pruritus, scarring, and Koebner phenomenon, will be documented and analyzed, including their incidence, severity, and association with the interventions.
Measured: From enrollment to the end of treatment at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 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.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, randomized controlled study. Participants are randomly assigned to two groups, receiving central nevus excision plus medication or conservative medication only, respectively. The study aims to compare the efficacy and safety of the two interventions for treating halo nevus accompanied by non-segmental vitiligo.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Jian, Principal investigator, First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307534
- Sponsor's protocol ID
- XJPF-LCY-V2025121
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Nevus Removal Versus Conservative Treatment for Halo Nevus With Vitiligo: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07307534
- Acronym / sponsor ID
- XJPF-LCY-V2025121
- Conditions
- Vitiligo, Halo Nevus
- Keywords
- Vitiligo, Halo nevus, Randomized Controlled Trial, Tacrolimus, NB-UVB, Nevus excision, Treatment comparison, Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 29 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.
This clinical trial aims to compare the efficacy and safety of central nevus removal versus conservative treatment in patients with halo nevus accompanied by non-segmental vitiligo. It is a single-center, prospective, randomized controlled trial involving 60 participants aged 6 to 45 years, who will be randomly assigned to either the nevus removal group or the conservative treatment group. The removal group will undergo surgical or laser excision of the central nevus followed by medication, while the conservative group will receive medication only. Both groups will be followed for 6 months. Outcomes include repigmentation assessment using vitiligo scoring indices, quality of life measures, and serial serum cytokine profiling. The study seeks to provide high-level evidence to guide clinical management of halo nevus with vitiligo. Key points:
- For patients with halo nevus accompanied by non-segmental vitiligo.
- For patients aged 6 to 45 years.
- Compares nevus excision and conservative treatment.
- Follows participants for 6 months.
- Focuses on effectiveness and safety.
Detailed description
Background:
Halo nevus and vitiligo are both autoimmune pigment loss disorders that frequently co-occur and share overlapping immune pathways. Current management of halo nevus with vitiligo remains controversial: removal of the central nevus may eliminate an immune target and promote repigmentation but carries risks of Koebner phenomenon and scarring; conservative treatment avoids procedural trauma but may yield slower or suboptimal responses. Robust prospective comparisons of these strategies are lacking.
- Study Design: Single-center, randomized controlled trial. Sixty patients with halo nevus and non-segmental vitiligo (BSA ≤2%) will be randomized 1:1 to the excision group or the conservative group.
- Excision group: Central nevus removal via CO₂ laser (if diameter <0.3 cm) or surgical excision (if ≥0.3 cm), followed by standardized medication after 1 week.
- Conservative group: Standardized medication only, without nevus removal. The standardized medication regimen is as follows: For stable disease, apply topical 0.1% tacrolimus ointment twice daily combined with NB-UVB phototherapy once every other day. For active or progressive cases, oral prednisone (prednisone acetate, 0.3 mg/kg/day) is added to the above stable-stage regimen.
- Duration: 6 months with follow-ups at 1, 3, 6 months.
- Outcome Measures: Primary Endpoint: Percentage of participants achieving VASl50 response Secondary Endpoints: Percentage of participants achieving VASI75 and VASI90 responses at each follow-up time point; changes in VASI, VSAS, VES, VETF scores; proportion of participants achieving lGA score improvement; patient-reported outcomes (DLQI/CDLQI, VitiQoL); incidence of treatment-emergent adverse events Other Pre-specified Outcomes: Changes in 12 serum cytokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-17, IFN-α, IFN-γ, TNF-α).
- Statistical Methods: Categorical data will be presented as frequencies and percentages, continuous data as mean ± SD. Between-group comparisons will use chi-square tests, Fisher's exact test, independent t-test, or Mann-Whitney U test as appropriate. Multivariate analysis will employ logistic regression. SPSS, R 4.3.2, and GraphPad Prism will be used for analysis (significance: p ≤ 0.05). The primary and secondary efficacy endpoints will be analyzed using the intention-to-treat (ITT) principle, with sensitivity analysis performed on the per-protocol (PP) population.
- Ethics \& Compliance: Approved by the Ethics Committee of the First Affiliated Hospital of Air Force Medical University. Informed consent is obtained from all participants' guardians.
- Significance: This trial will systematically evaluate the clinical and immunological effects of central nevus removal versus conservative management in halo nevus with vitiligo, aiming to optimize treatment strategies and provide evidence-based guidance for clinicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, randomized controlled study. Participants are randomly assigned to two groups, receiving central nevus excision plus medication or conservative medication only, respectively. The study aims to compare the efficacy and safety of the two interventions for treating halo nevus accompanied by non-segmental vitiligo.
| Arm | Type | Receives |
|---|---|---|
| Central Nevus Excision Group | Experimental | Procedure: Central Nevus Excision, Combination Product: The Standardized Medication RegimenParticipants in this arm undergo surgical or laser excision of the central nevus, with standardized medication initiated one week postoperatively. |
| Conservative Treatment Group | Active comparator | Combination Product: The Standardized Medication RegimenParticipants in this arm receive standardized medication only without nevus removal. |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with halo nevus accompanied by non-segmental vitiligo, with BSA ≤2% (excluding acral regions).
Key exclusion criteria (5 listed)
- History of keloid formation or hypertrophic scarring (to avoid abnormal hyperplasia at the operative site and interference with repigmentation assessment)
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 |
|---|---|---|
| Central Nevus ExcisionParticipants undergo removal of the central halo nevus based on its diameter: Diameter <0.3 cm: CO₂ laser ablation. Diameter ≥0.3 cm: Surgical excision. All procedures are performed under local anesthesia with strict aseptic technique. Postoperative care and wound management are provided according to standard protocols. | Procedure or surgery | Central Nevus Excision Group |
| The Standardized Medication RegimenFor stable disease, apply topical 0.1% tacrolimus ointment twice daily combined with NB-UVB phototherapy once every other day. For active or progressive cases, oral prednisone (prednisone acetate, 0.3 mg/kg/day) is added to the above stable-stage regimen. | Combination product | Central Nevus Excision Group, Conservative Treatment Group |
Primary outcome
Percentage of Participants Achieving VASl50 Response
Time frame: From enrollment to the end of treatment at 6 months.
VASl (Vitiligo Area and Severity lndex) 50 response is defined as a 50% or greater reduction in VASl score from baseline. Assessment is conducted by trained dermatologists using standardized VASl scoring criteria.
9 secondary outcomes
Percentage of Participants Achieving VASI75 and VASI90 responses at each follow-up time point
Time frame: From enrollment to the end of treatment at 6 months.
Change in Vitiligo Area and Severity Index (VASl) Score
Time frame: From enrollment to the end of treatment at 6 months.
Change in Vitiligo Signs of Activity Score (VSAS) Score
Time frame: From enrollment to the end of treatment at 6 months.
Change in Vitiligo Extent Score (VES) Score
Time frame: From enrollment to the end of treatment at 6 months.
Change in Vitiligo European Task Force (VETF) Score
Time frame: From enrollment to the end of treatment at 6 months.
Change in Dermatology life quality index (DLQI) Score
Time frame: From enrollment to the end of treatment at 6 months.
Change in The Vitiligo-specific Quality-of-Life instrument (VitiQoL) Score
Time frame: From enrollment to the end of treatment at 6 months.
Proportion of Participants Achieving investigator Global Assessment (lGA) Score lmprovement
Time frame: From enrollment to the end of treatment at 6 months.
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment to the end of treatment at 6 months.
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 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Zhe Jian principal investigator
First Affiliated Hospital of Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central Nevus Excision and The Standardized Medication Regimen in people with Vitiligo and Halo Nevus, 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 3 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 15 Jan 2026. 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 Zhe Jian (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?
Percentage of Participants Achieving VASl50 Response (time frame: From enrollment to the end of treatment at 6 months.). 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 15 Jan 2026.