Vitiligo - Macular DepigmentationPhase 2NCT07548918
Comparative Study of Microneedling With Topical Minoxidil 5% ± NB-UVB in Stable Vitiligo"
A Phase 2 study testing microneedling with minoxidil 5% and NBUVB and Microneedling with Minoxidil5% in people with Vitiligo - Macular Depigmentation, run by Sohag University.
Trial summary
This study is a randomized controlled trial comparing microneedling with topical minoxidil 5% versus microneedling with minoxidil combined with NB-UVB phototherapy in stable vitiligo. It aims to evaluate both clinical and histopathological outcomes in 30 patients with non-segmental stable vitiligo. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo - Macular Depigmentation
- What is being tested?
- microneedling with minoxidil 5% and NBUVB and Microneedling with Minoxidil5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 15 Oct 2027
- Phase
- Phase 2
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with stable non-segmental vitiligo
- No new lesions
- No enlargement of existing lesions
- Patients of both sexes
- Age 16 years or older
Who cannot join
- Active vitiligo
- Pregnant or lactating women
- History of keloid formation
- Hematological disorders
- Coagulopathies
- Use of anticoagulant therapy
- Use of medications that may prolong bleeding
- Previous vitiligo treatment in the last 2 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Clinical and Histopathological Study of Microneedling With Topical Minoxidil 5% Versus Microneedling With Topical Minoxidil 5% Combined With Narrow-Band Ultraviolet B Phototherapy in the Treatment of Stable Vitiligo
This study is a randomized controlled trial comparing microneedling with topical minoxidil 5% versus microneedling with minoxidil combined with NB-UVB phototherapy in stable vitiligo.
It aims to evaluate both clinical and histopathological outcomes in 30 patients with non-segmental stable vitiligo.
Vitiligo is a chronic depigmenting disorder caused by melanocyte destruction with significant psychosocial impact.
The study also investigates immunohistochemical changes, particularly Wnt/β-catenin signaling expression in lesional skin.
The combination therapy is expected to enhance repigmentation by improving melanocyte activation, drug delivery, and angiogenesis
- Conditions
- Vitiligo - Macular Depigmentation
- Being tested
- microneedling with minoxidil 5% and NBUVB, Microneedling with Minoxidil5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedling with minoxidil 5% and NBUVBCombination product
Micronnedlin depth 1% then topical Minoxidil5% and Narrow Band UVB
Microneedling with Minoxidil5%Combination product
Microneedling with topical Minoxidil 5%
| Study group | Role | What they receive |
|---|---|---|
| Microneedling + minoxidil5% | Active comparator | Not described Receives: Combination Product: Microneedling with Minoxidil5% |
| Microneedling + minoxidil5% +NBUVB | Active comparator | Not described Receives: Combination Product: microneedling with minoxidil 5% and NBUVB; Combination Product: Microneedling with Minoxidil5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation in the vitiliginous area after receiving the treatment and increasing the wnt b catenin marker level in the histopathological specimen
Measured: From enrollment to the end of treatment at 16 weeks for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start20 May 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitiligo - Macular DepigmentationStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Heshameldien Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548918
- Sponsor's protocol ID
- Soh-Med-26-3-5MS
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelghany, n. i., r. s. abdo and W. M. Abdelmaged (2022). "Microneedling in treatment of vitiligo: a review article." Sohag Medical Journal 26(1): 1-7. Bajoria, S., C. R. Srinivas, N. Satish, R. Sukhija, K. Jain, G. Manocha and L. Besra (2025). "Phototherapy with Topical Minoxidil in Vitiligo: A Randomized Control Trial." Indian Dermatol Online J. Elshafy Khashaba, S. A., R. A. Elkot and A. M. Ibrahim (2018). "Efficacy of NB-UVB, microneedling with triamcinolone acetonide, and a combination of both modalities in the treatment of vitiligo: A comparative study." J Am Acad Dermatol 79(2): 365-367. Hamzavi, I., H. Jain, D. McLean, J. Shapiro, H. Zeng and H. Lui (2004). "Parametric Modeling of Narrowband UV-B Phototherapy for Vitiligo Using a Novel Quantitative Tool: The Vitiligo Area Scoring Index." Archives of Dermatology140(6): 677-683. Iannella, G., A. Greco, D. Didona, B. Didona, G. Granata, A. Manno, B. Pasquariello and G. Magliulo (2016). "Vitiligo: Pathogenesis, clinical variants and treatment approaches." Autoimmun Rev 15(4): 335-343. Khandpur, S., S. Singh and D. Paul (2025). "Clinical efficacy and safety profile of handheld narrow band ultraviolet B device therapy in vitiligo - Systematic review and meta-analysis." Indian J Dermatol Venereol Leprol 91(3): 321-331. Krüger, C. and K. U. Schallreuter (2012). "A review of the worldwide prevalence of vitiligo in children/adolescents and adults." Int J Dermatol51(10): 1206-1212. Lepe, V., B. Moncada, J. P. Castanedo-Cazares, M. B. Torres-Alvarez, C. A. Ortiz and A. B. Torres-Rubalcava (2003). "A double-blind randomized trial of 0.1% tacrolimus vs 0.05% clobetasol for the treatment of childhood vitiligo." Arch Dermatol 139(5): 581-585. Lin, X., X. Meng and J. Lin (2023). "The possible role of Wnt/β-catenin signalling in vitiligo treatment." J Eur Acad Dermatol Venereol 37(11): 2208-2221. Lotfy, S. S., Y. M. E.-H. Neinaa, N. E.-S. R. Ghaly and N. N. Doghaim (2021). "Efficacy of Skin Microneedling in Combina
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical and Histopathological Study of Microneedling With Topical Minoxidil 5% Versus Microneedling With Topical Minoxidil 5% Combined With Narrow-Band Ultraviolet B Phototherapy in the Treatment of Stable Vitiligo
- ClinicalTrials.gov ID
- NCT07548918
- Acronym / sponsor ID
- Soh-Med-26-3-5MS
- Conditions
- Vitiligo - Macular Depigmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 23 Apr 2026 (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 study is a randomized controlled trial comparing microneedling with topical minoxidil 5% versus microneedling with minoxidil combined with NB-UVB phototherapy in stable vitiligo.
It aims to evaluate both clinical and histopathological outcomes in 30 patients with non-segmental stable vitiligo.
Vitiligo is a chronic depigmenting disorder caused by melanocyte destruction with significant psychosocial impact.
The study also investigates immunohistochemical changes, particularly Wnt/β-catenin signaling expression in lesional skin.
The combination therapy is expected to enhance repigmentation by improving melanocyte activation, drug delivery, and angiogenesis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling + minoxidil5% | Active comparator | Combination Product: Microneedling with Minoxidil5% |
| Microneedling + minoxidil5% +NBUVB | Active comparator | Combination Product: microneedling with minoxidil 5% and NBUVB, Combination Product: Microneedling with Minoxidil5% |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with stable non-segmental vitiligo
- No new lesions
- No enlargement of existing lesions
- Patients of both sexes
- Age 16 years or older
Key exclusion criteria (8 listed)
- Active vitiligo
- Pregnant or lactating women
- History of keloid formation
- Hematological disorders
- Coagulopathies
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 |
|---|---|---|
| microneedling with minoxidil 5% and NBUVBMicronnedlin depth 1% then topical Minoxidil5% and Narrow Band UVB | Combination product | Microneedling + minoxidil5% +NBUVB |
| Microneedling with Minoxidil5%Microneedling with topical Minoxidil 5% | Combination product | Microneedling + minoxidil5%, Microneedling + minoxidil5% +NBUVB |
Primary outcome
Repigmentation in the vitiliginous area after receiving the treatment and increasing the wnt b catenin marker level in the histopathological specimen
Time frame: From enrollment to the end of treatment at 16 weeks for each patient
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 29 Apr 2026.
- BackgroundAbdelghany, n. i., r. s. abdo and W. M. Abdelmaged (2022). "Microneedling in treatment of vitiligo: a review article." Sohag Medical Journal 26(1): 1-7. Bajoria, S., C. R. Srinivas, N. Satish, R. Sukhija, K. Jain, G. Manocha and L. Besra (2025). "Phototherapy with Topical Minoxidil in Vitiligo: A Randomized Control Trial." Indian Dermatol Online J. Elshafy Khashaba, S. A., R. A. Elkot and A. M. Ibrahim (2018). "Efficacy of NB-UVB, microneedling with triamcinolone acetonide, and a combination of both modalities in the treatment of vitiligo: A comparative study." J Am Acad Dermatol 79(2): 365-367. Hamzavi, I., H. Jain, D. McLean, J. Shapiro, H. Zeng and H. Lui (2004). "Parametric Modeling of Narrowband UV-B Phototherapy for Vitiligo Using a Novel Quantitative Tool: The Vitiligo Area Scoring Index." Archives of Dermatology140(6): 677-683. Iannella, G., A. Greco, D. Didona, B. Didona, G. Granata, A. Manno, B. Pasquariello and G. Magliulo (2016). "Vitiligo: Pathogenesis, clinical variants and treatment approaches." Autoimmun Rev 15(4): 335-343. Khandpur, S., S. Singh and D. Paul (2025). "Clinical efficacy and safety profile of handheld narrow band ultraviolet B device therapy in vitiligo - Systematic review and meta-analysis." Indian J Dermatol Venereol Leprol 91(3): 321-331. Krüger, C. and K. U. Schallreuter (2012). "A review of the worldwide prevalence of vitiligo in children/adolescents and adults." Int J Dermatol51(10): 1206-1212. Lepe, V., B. Moncada, J. P. Castanedo-Cazares, M. B. Torres-Alvarez, C. A. Ortiz and A. B. Torres-Rubalcava (2003). "A double-blind randomized trial of 0.1% tacrolimus vs 0.05% clobetasol for the treatment of childhood vitiligo." Arch Dermatol 139(5): 581-585. Lin, X., X. Meng and J. Lin (2023). "The possible role of Wnt/β-catenin signalling in vitiligo treatment." J Eur Acad Dermatol Venereol 37(11): 2208-2221. Lotfy, S. S., Y. M. E.-H. Neinaa, N. E.-S. R. Ghaly and N. N. Doghaim (2021). "Efficacy of Skin Microneedling in Combina
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing microneedling with minoxidil 5% and NBUVB and Microneedling with Minoxidil5% in people with Vitiligo - Macular Depigmentation, run by Sohag University.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rasha Hesham el dein mohammed, Bachelor (+201111199719, rashahesham15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repigmentation in the vitiliginous area after receiving the treatment and increasing the wnt b catenin marker level in the histopathological specimen (time frame: From enrollment to the end of treatment at 16 weeks for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07548918, which also lists 1 linked publication.
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 29 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.