Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

Phase 4RecruitingNCT06991972

Khyber Teaching Hospital80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vitiligo Non-segmental Vitiligo

Interventions

Needling + NBUVBPROCEDURE

Participants in this arm will undergo needling using a sterile 30G (4mm) needle to manually puncture and implant melanocytes from perilesional pigmented skin into depigmented lesions. The procedure will be performed once every four weeks for a total of six sessions.

Microneedling + NBUVBPROCEDURE

Participants in this arm will undergo microneedling using a Dermapen device with 1.5 mm needles to create controlled micro-injuries in depigmented skin to enhance melanocyte migration and repigmentation. This procedure will be performed once every four weeks for six sessions.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Khyber Teaching Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

RECRUITING

Outcomes

Primary Outcomes

Treatment efficacy

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. The higher the score, the more effective is the treatment modality. 0-25% re pigmentation= Mildimprovement 25-50% re pigmentation= Moderate improvement 51-75% re pigmentation= Good 76-100% re pigmentation= Excellent to complete

Time frame: 12 weeks

Secondary Outcomes

Adverse effects

erythema, post-inflammatory hyperpigmentation, infection, scarring

Time frame: 12 weeks

Central Contacts

Huma Gul Doctor, MBBS

CONTACT

+923471927046 xaffar965@gmail.com

Data from ClinicalTrials.gov

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