Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitiligo Non-segmental Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Needling + NBUVB(Group A)

Group Type ACTIVE_COMPARATOR

Microneedling + NBUVB

Intervention Type PROCEDURE

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.

Microneedling + NBUVB(Group B)

Group Type ACTIVE_COMPARATOR

Needling + NBUVB

Intervention Type PROCEDURE

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.

Interventions

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Needling + NBUVB

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.

Intervention Type PROCEDURE

Microneedling + NBUVB

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No