Puncture to Repigment: A Comparative Analysis Of Needling vs. Microneedling Along With NBUVB in Treatment of Non-Segmental Vitiligo
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Khyber Teaching Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Treatment efficacy
Study Overview
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 15 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Microneedling + NBUVB(Group B)
Intervention: Needling + NBUVB (Procedure)
Needling + NBUVB(Group A)
Intervention: Microneedling + NBUVB (Procedure)
Outcomes
Primary Outcomes
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
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
- Adverse effects(12 weeks)
Investigators
Huma Gul
DOCTOR
Khyber Teaching Hospital