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Not yet recruitingNCT07548918Updated Apr 29, 2026

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

A Phase 2 interventional study of microneedling with minoxidil 5% and NBUVB and Microneedling with Minoxidil5% in Vitiligo - Macular Depigmentation, sponsored by Sohag University. Not yet recruiting. Open to participants aged 16 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Sohag University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
16 Years to 60 Years
Sex
All
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Study 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

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Conditions studied

  • Vitiligo - Macular Depigmentation
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In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Microneedling + minoxidil5%

    Combination Product: Microneedling with Minoxidil5%

  • Active comparator
    Microneedling + minoxidil5% +NBUVB

    Combination Product: microneedling with minoxidil 5% and NBUVB · Combination Product: Microneedling with Minoxidil5%

Interventions

  • Combination productmicroneedling with minoxidil 5% and NBUVB

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

  • Combination productMicroneedling with Minoxidil5%

    Microneedling with topical Minoxidil 5%

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What researchers measure

Primary outcomes

  1. 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

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Study locations

No study locations are listed for this record.

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References and documents

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

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07548918
Lead sponsor
Sohag University
Responsible party
Rasha Heshameldien Mohamed (doctor, Sohag University) — Principal investigator
First posted
Apr 23, 2026
Start date
May 20, 2026 (estimated)
Primary completion
Feb 15, 2027 (estimated)
Completion
Oct 15, 2027 (estimated)
Last update
Apr 29, 2026

Study contacts

Rasha Hesham el dein mohammed, Bachelor
Contact
rashahesham15@gmail.com
+201111199719

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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