Nevus Removal vs. Conservative Treatment in Halo Nevus With Vitiligo: A Randomized Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-45
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Central Nevus Excision
Procedure/SurgeryParticipants 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
Combination productFor 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Central Nevus Excision GroupExperimental treatment 2 interventions
Group B: Conservative Treatment GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Achieving VASl50 Response
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.
Time frame
From enrollment to the end of treatment at 6 months.Secondary outcomes
1
Percentage of Participants Achieving VASI75 and VASI90 responses at each follow-up time point
VASl75 (or VASI90) response is defined as a 75% (or 90%) or greater reduction in VASl score from baseline. Assessment is conducted by trained dermatologists using standardized VASl scoring criteria.
Time frame
From enrollment to the end of treatment at 6 months.2
Change in Vitiligo Area and Severity Index (VASl) Score
Calculate the difference between the VASl score at 6 months and the baseline VASl score, including the mean percentage change in VASI from baseline at 6 months. This reflects the improvement vitiligo area and severity over the treatment period.
Time frame
From enrollment to the end of treatment at 6 months.3
Change in Vitiligo Signs of Activity Score (VSAS) Score
Calculate the difference between the VSAS score at 6 months and the baseline VSAS score.
Time frame
From enrollment to the end of treatment at 6 months.4
Change in Vitiligo Extent Score (VES) Score
Calculate the difference between the VES score at 6 months and the baseline VES score.
Time frame
From enrollment to the end of treatment at 6 months.Other outcomes
1
Changes in levels of 12 serum cytokines
Venous blood will be collected from the elbow at baseline and at 1, 3, and 6 months post-treatment to measure 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). The changes in levels will be statistically analyzed to explore their correlation with clinical response and the underlying mechanisms of treatment.
Time frame
From enrollment to the end of treatment at 6 months.Sponsors and contacts
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Source ClinicalTrials.gov
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