Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients

ConditionsVitiligo Non-segmental Vitiligo

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age15-60

SponsorKhyber Teaching Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both male and female

Age 15-60 years

Patients having vitiligo for more than 1 year

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Needling + NBUVB
Procedure/Surgery
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/Surgery
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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Needling + NBUVB(Group A)Active comparator 1 intervention

Group B: Microneedling + NBUVB(Group B)Active comparator 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Khyber Teaching Hospital

Lead sponsor

Source ClinicalTrials.gov

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