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Nevus Removal vs. Conservative Treatment in Halo Nevus With Vitiligo: A Randomized Study
Sponsor: Xijing Hospital
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.
Official title: Central Nevus Removal Versus Conservative Treatment for Halo Nevus With Vitiligo: A Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
6 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-01-20
Completion Date
2027-10-01
Last Updated
2026-01-15
Healthy Volunteers
No
Conditions
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.
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.
Locations (1)
Xijing Hospital
Xi'an, Shaanxi, China