VitiligoPhase 4NCT06991972
Comparison of Needling and Microneedling Plus Phototherapy in Localized Vitiligo Patients
A Phase 4 study testing Needling + NBUVB and Microneedling + NBUVB in people with Vitiligo and Non-segmental Vitiligo, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Vitiligo, Non-segmental Vitiligo
- What is being tested?
- Needling + NBUVB and Microneedling + NBUVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 31 Aug 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both male and female
- Age 15-60 years
- Patients having vitiligo for more than 1 year
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Khyber Teaching Hospital
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Puncture to Repigment: A Comparative Analysis Of Needling vs. Microneedling Along With NBUVB in Treatment of Non-Segmental Vitiligo
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.
Read the 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.
- Conditions
- Vitiligo, Non-segmental Vitiligo
- Being tested
- Needling + NBUVB, Microneedling + NBUVB
- Keywords
- vitiligo, needling, microneedling
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needling + NBUVBProcedure or 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 + NBUVBProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Needling + NBUVB(Group A) | Active comparator | Not described Receives: Procedure: Microneedling + NBUVB |
| Microneedling + NBUVB(Group B) | Active comparator | Not described Receives: Procedure: Needling + NBUVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
Adverse effects
erythema, post-inflammatory hyperpigmentation, infection, scarring
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Mar 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huma Gul, Khyber Teaching Hospital
- Investigators
- Huma Gul Doctor, MBBS, Principal investigator, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991972
- Sponsor's protocol ID
- 187/DME/KMC
- Status last verified
- Aug 2025
- First submitted
- 19 May 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient's confidentiality may not be breached
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puncture to Repigment: A Comparative Analysis Of Needling vs. Microneedling Along With NBUVB in Treatment of Non-Segmental Vitiligo
- ClinicalTrials.gov ID
- NCT06991972
- Acronym / sponsor ID
- 187/DME/KMC
- Conditions
- Vitiligo, Non-segmental Vitiligo
- Keywords
- vitiligo, needling, microneedling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needling + NBUVB(Group A) | Active comparator | Procedure: Microneedling + NBUVB |
| Microneedling + NBUVB(Group B) | Active comparator | Procedure: Needling + NBUVB |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Both male and female
- Age 15-60 years
- Patients having vitiligo for more than 1 year
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needling + NBUVBParticipants 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. | Procedure or surgery | Microneedling + NBUVB(Group B) |
| Microneedling + NBUVBParticipants 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. | Procedure or surgery | Needling + NBUVB(Group A) |
Primary outcome
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
1 secondary outcome
Adverse effects
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No. Patient's confidentiality may not be breached
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huma Gul Doctor, MBBS principal investigator
Khyber Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Needling + NBUVB and Microneedling + NBUVB in people with Vitiligo and Non-segmental Vitiligo, run by Khyber Teaching Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huma Gul Doctor, MBBS (+923471927046 ext. +923177627046, xaffar965@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.