Clinical trial · Interventional
Nevus Removal vs. Conservative Treatment in Halo Nevus With Vitiligo: A Randomized Study
Central Nevus Removal Versus Conservative Treatment for Halo Nevus With Vitiligo: A Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Halo Nevus | Halo Nevus | ONTOLOGY_EXACT | 0.98 |
| Vitiligo | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Central Nevus Excision | Procedure | — | UNRESOLVED |
| The Standardized Medication Regimen | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Central Nevus Excision Group
- description
- Participants in this arm undergo surgical or laser excision of the central nevus, with standardized medication initiated one week postoperatively.
- interventionNames
- Procedure: Central Nevus Excision
- Combination Product: The Standardized Medication Regimen
- type
- ACTIVE_COMPARATOR
- label
- Conservative Treatment Group
- description
- Participants in this arm receive standardized medication only without nevus removal.
- interventionNames
- Combination Product: The Standardized Medication Regimen
Primary outcomes (1)
- measure
- Percentage of Participants Achieving VASl50 Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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 observationsReferences
Publications (0)
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