Central Nevus Removal Versus Conservative Treatment for Halo Nevus With Vitiligo: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving VASl50 Response
研究概览
简要总结
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 ≤50 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:
- For patients with halo nevus accompanied by non-segmental vitiligo.
- Compares nevus excision and conservative treatment.
- Follows participants for 6 months.
- Focuses on effectiveness and safety.
详细描述
Background:
Halo nevus and vitiligo are both autoimmune pigment loss disorders that frequently co-occur and share overlapping immune pathways. Current management of halo nevus with vitiligo remains controversial: removal of the central nevus may eliminate an immune target and promote repigmentation but carries risks of Koebner phenomenon and scarring; conservative treatment avoids procedural trauma but may yield slower or suboptimal responses. Robust prospective comparisons of these strategies are lacking.
- Study Design:
Single-center, randomized controlled trial. Sixty patients with halo nevus and non-segmental vitiligo (BSA ≤2%) will be randomized 1:1 to the excision group or the conservative group. 2. Excision group: Central nevus removal via CO₂ laser (if diameter <0.3 cm) or surgical excision (if ≥0.3 cm), followed by standardized medication after 1 week. 3. Conservative group: Standardized medication only, without nevus removal. The standardized medication regimen is as follows:
For stable disease, apply topical 0.1% tacrolimus ointment twice daily combined with NB-UVB phototherapy once every other day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤50 years, regardless of gender ④ Physically able to tolerate surgery and local anesthesia
排除标准
- •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
结局指标
主要结局
Percentage of Participants Achieving VASl50 Response
时间窗: From enrollment to the end of treatment at 6 months.
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.
次要结局
- Change in Vitiligo Area and Severity Index (VASl) Score(From enrollment to the end of treatment at 6 months.)
- 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 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.)
- Incidence of Treatment-Emergent Adverse Events(From enrollment to the end of treatment at 6 months.)
- Proportion of Participants Achieving investigator Global Assessment (lGA) Score lmprovement(From enrollment to the end of treatment at 6 months.)
- Change in Dermatology life quality index (DLQI) Score(From enrollment to the end of treatment at 6 months.)
- Change in The Vitiligo-specific Quality-of-Life instrument (VitiQoL) Score(From enrollment to the end of treatment at 6 months.)