NCT06991972

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

May 19, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

vitiligoneedlingmicroneedling

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (1)

  • Adverse effects

    12 weeks

Study Arms (2)

Needling + NBUVB(Group A)

ACTIVE COMPARATOR
Procedure: Microneedling + NBUVB

Microneedling + NBUVB(Group B)

ACTIVE COMPARATOR
Procedure: Needling + NBUVB

Interventions

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(Group B)

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.

Needling + NBUVB(Group A)

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

  • Huma Gul Doctor, MBBS

    Khyber Teaching Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huma Gul Doctor, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 28, 2025

Study Start

March 1, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Patient's confidentiality may not be breached

Locations