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

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.

1. 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.

For active or progressive cases, oral prednisone (prednisone acetate, 0.3 mg/kg/day) is added to the above stable-stage regimen. 4. Duration: 6 months with follow-ups at 1, 3, 6 months. 5. Outcome Measures:

Primary Endpoint: Percentage of participants achieving VASl50 response Secondary Endpoints: Percentage of participants achieving VASI75 and VASI90 responses at each follow-up time point; changes in VASI, VSAS, VES, VETF scores; proportion of participants achieving lGA score improvement; patient-reported outcomes (DLQI/CDLQI, VitiQoL); incidence of treatment-emergent adverse events Other Pre-specified Outcomes: Changes in 12 serum cytokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-17, IFN-α, IFN-γ, TNF-α). 6. Statistical Methods: Categorical data will be presented as frequencies and percentages, continuous data as mean ± SD. Between-group comparisons will use chi-square tests, Fisher's exact test, independent t-test, or Mann-Whitney U test as appropriate. Multivariate analysis will employ logistic regression. SPSS, R 4.3.2, and GraphPad Prism will be used for analysis (significance: p ≤ 0.05). The primary and secondary efficacy endpoints will be analyzed using the intention-to-treat (ITT) principle, with sensitivity analysis performed on the per-protocol (PP) population. 7. Ethics \& Compliance: Approved by the Ethics Committee of the First Affiliated Hospital of Air Force Medical University. Informed consent is obtained from all participants' guardians. 8. Significance: This trial will systematically evaluate the clinical and immunological effects of central nevus removal versus conservative management in halo nevus with vitiligo, aiming to optimize treatment strategies and provide evidence-based guidance for clinicians.

• Percentage of Participants Achieving VASI75 and VASI90 responses at each follow-up time point [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in Vitiligo Area and Severity Index (VASl) Score [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in Vitiligo Signs of Activity Score (VSAS) Score [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in Vitiligo Extent Score (VES) Score [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in Vitiligo European Task Force (VETF) Score [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in Dermatology life quality index (DLQI) Score [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Change in The Vitiligo-specific Quality-of-Life instrument (VitiQoL) Score [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Proportion of Participants Achieving investigator Global Assessment (lGA) Score lmprovement [Срок оценки: From enrollment to the end of treatment at 6 months.]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: From enrollment to the end of treatment at 6 months.]