Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

Phase 4

Recruiting

• Conditions: Vitiligo; Non-segmental Vitiligo

• Registration Number: NCT06991972
• Lead Sponsor: Khyber Teaching Hospital

Brief Summary

This randomized controlled trial aims to compare the efficacy of needling versus microneedling, both followed by narrowband UVB therapy, in achieving repigmentation in patients with localized stable non-segmental vitiligo.

Detailed Description

The study will enroll 80 patients aged 15-60 years with localized stable vitiligo. Participants will be randomized into two groups: one receiving needling and the other microneedling, each followed by NBUVB therapy. The primary outcome is the percentage of repigmentation at 12 weeks, assessed through digital planimetry and standardized clinical photography. Secondary outcomes include adverse effects such as erythema, post-inflammatory hyperpigmentation, infection, and scarring.

Study Timeline

• Study Start: 2025-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Both male and female
• Age 15-60 years
• Patients having vitiligo for more than 1 year

Exclusion Criteria

• Patients with tendency of keloid formation or hypertrophic scarring
• Patients with any bleeding disorder, coagulation defect or using anti platelets
• Any local infection at the treatment site
• Patients who had received systemic therapy in last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment efficacy	12 weeks	Efficacy will be assessed at 12 weeks using the Physician's Global Assessment Scale. Improvement is defined as ≥25% repigmentation of vitiliginous patches, measured via digital planimetry and standardized clinical photography.; ≥25% repigmentation → Improved \<25% repigmentation → Not Improved

Secondary Outcome Measures

Name	Time	Method
Adverse effects	12 weeks	erythema, post-inflammatory hyperpigmentation, infection, scarring

Trial Locations

Locations (1)

Khyber Teaching Hospital; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan