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NCT Number: NCT06991972

Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

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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Key information

Conditions

Vitiligo Hypopigmentation Non-Segmental Vitiligo Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Khyber Teaching Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Needling + NBUVB

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.

Microneedling + NBUVB

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.

Primary outcomes

  1. Treatment efficacy

    Time frame: 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. 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

Secondary outcomes

  1. Adverse effects

    Time frame: 12 weeks

    erythema, post-inflammatory hyperpigmentation, infection, scarring

Study contacts

Contact information is provided by the study sponsor or research team.

Huma Gul Doctor, MBBS

CONTACT

[email protected]

+923471927046 ext. +923177627046

Sponsors and collaborators

Lead sponsor

Khyber Teaching Hospital

Other

Registry information

Official study title

Puncture to Repigment: A Comparative Analysis Of Needling vs. Microneedling Along With NBUVB in Treatment of Non-Segmental Vitiligo

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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