Central Nevus Removal Versus Conservative Treatment for Halo Nevus With Vitiligo: A Prospective Randomized Controlled Trial

NCT ID: NCT07307534

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-10-01

Brief 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. It is a single-center, prospective, randomized controlled trial involving 60 participants aged ≤50 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:

1. For patients with halo nevus accompanied by non-segmental vitiligo.

2. Compares nevus excision and conservative treatment.

3. Follows participants for 6 months.

4. 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.

1. 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.

2. 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.

3. 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.

4. Duration: 6 months with follow-ups at 1, 3, 6 months.

5. 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).

6. 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.

7. 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.

8. 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

Keywords

Vitiligo; Halo nevus; Randomized Controlled Trial; Tacrolimus; NB-UVB; Nevus excision; Treatment comparison; Efficacy; Safety; VASI score

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Central Nevus Excision Group

Participants in this arm undergo surgical or laser excision of the central nevus, with standardized medication initiated one week postoperatively.

Group Type: EXPERIMENTAL

Central Nevus Excision

Intervention Type: PROCEDURE

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 Regimen

Intervention Type: COMBINATION_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.

Conservative Treatment Group

Participants in this arm receive standardized medication only without nevus removal.

Group Type: ACTIVE_COMPARATOR

The Standardized Medication Regimen

Intervention Type: COMBINATION_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.

Interventions

Central Nevus Excision

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.

Intervention Type: PROCEDURE

The Standardized Medication Regimen

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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 ≤50 years, regardless of gender ④ Physically able to tolerate surgery and local anesthesia

Exclusion Criteria

• 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

• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhe Jian

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Air Force Medical University

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Zhe Jian

Role: CONTACT

Phone: 8615332332587

Email: xjzhejian@fmmu.edu.cn

Facility Contacts

Zhe Jian

Role: primary

Other Identifiers

XJPF-LCY-V2025121

Identifier Type: -

Identifier Source: org_study_id