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

NCT07548918 | Not Yet Recruiting Phase 2

• 1 other identifier: Soh-Med-26-3-5MS
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Repigmentation in the vitiliginous area after receiving the treatment and increasing the wnt b catenin marker level in the histopathological specimen

  From enrollment to the end of treatment at 16 weeks for each patient

Study Arms (2)

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%

Interventions

microneedling with minoxidil 5% and NBUVB COMBINATION_PRODUCT

Micronnedlin depth 1% then topical Minoxidil5% and Narrow Band UVB

Microneedling + minoxidil5% +NBUVB

Microneedling with Minoxidil5% COMBINATION_PRODUCT

Microneedling with topical Minoxidil 5%

Microneedling + minoxidil5%; Microneedling + minoxidil5% +NBUVB

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Interventions

Percutaneous Collagen Induction; Minoxidil

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Rasha Hesham el dein mohammed, Bachelor

CONTACT

+201111199719; rashahesham15@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share