Nevus Removal vs. Conservative Treatment in Halo Nevus With Vitiligo: A Randomized Study

NCT07307534 | Not Yet Recruiting DMC

• 1 other identifier: XJPF-LCY-V2025121
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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:

1. 1.For patients with halo nevus accompanied by non-segmental vitiligo.
2. 2.For patients aged 6 to 45 years.
3. 3.Compares nevus excision and conservative treatment.
4. 4.Follows participants for 6 months.
5. 5.Focuses on effectiveness and safety.

Conditions

Vitiligo; Halo Nevus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From enrollment to the end of treatment at 6 months.

• Change in Vitiligo Area and Severity Index (VASl) Score

  From enrollment to the end of treatment at 6 months.

• Change in Vitiligo Signs of Activity Score (VSAS) Score

  From enrollment to the end of treatment at 6 months.

• Change in Vitiligo Extent Score (VES) Score

  From enrollment to the end of treatment at 6 months.

• Change in Vitiligo European Task Force (VETF) Score

  From enrollment to the end of treatment at 6 months.

Other Outcomes (1)

• Changes in levels of 12 serum cytokines

  From enrollment to the end of treatment at 6 months.

Study Arms (2)

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.

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.

Combination Product: The Standardized Medication Regimen

Interventions

Central Nevus Excision 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.

Central Nevus Excision Group

The Standardized Medication Regimen 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.

Central Nevus Excision Group; Conservative Treatment Group

Eligibility Criteria

• Age: 6 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Vitiligo; Nevus, Halo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Nevus; Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Zhe Jian

  First Affiliated Hospital of Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Jian

CONTACT

8615332332587; xjzhejian@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)