Comparative Study of Microneedling With Topical Minoxidil 5% ± NB-UVB in Stable Vitiligo"

April 23, 2026 updated by: Rasha Heshameldien Mohamed, Sohag University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with stable non-segmental vitiligo
  • No new lesions
  • No enlargement of existing lesions
  • Patients of both sexes
  • Age 16 years or older

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Microneedling + minoxidil5%
Combination product: Microneedling with Minoxidil5%
Microneedling with topical Minoxidil 5%
Active Comparator: Microneedling + minoxidil5% +NBUVB
Combination product: Microneedling with Minoxidil5%
Microneedling with topical Minoxidil 5%
Combination product: microneedling with minoxidil 5% and NBUVB
Micronnedlin depth 1% then topical Minoxidil5% and Narrow Band UVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment to the end of treatment at 16 weeks for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-3-5MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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