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

NCT07307534 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-15

No results posted yet for this study

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

Conditions

  • Vitiligo
  • Halo Nevus

Interventions

PROCEDURE

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.

COMBINATION_PRODUCT

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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Zhe Jian · First Affiliated Hospital of Air Force Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-10-01
Completion
2027-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07307534 on ClinicalTrials.gov