Not Yet RecruitingNot Applicable

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

China60 participantsStarted 2026-01-20

Plain-language 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.

Who can participate

Age range

6 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 6 to 45 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Achieving VASl50 Response

Timeframe: From enrollment to the end of treatment at 6 months.

Trial details

NCT IDNCT07307534

SponsorXijing Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-01

Contact for this trial

Zhe Jian

8615332332587 xjzhejian@fmmu.edu.cn

View on ClinicalTrials.gov More Vitiligo trials