Non-segmental Vitiligo, Vitiligo
Conditions
Keywords
vitiligo, needling, microneedling
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.
Interventions
PROCEDURENeedling + 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.
PROCEDUREMicroneedling + 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.
Sponsors
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 12 weeks | erythema, post-inflammatory hyperpigmentation, infection, scarring |
Countries
Pakistan
Contacts
Primary ContactHuma Gul Doctor, MBBS
Outcome results
None listed