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CompletedNCT05467839Updated Oct 26, 2024

Evaluation of Efficacy of Microneedling and Topical Methotrexate Versus Microneedling and Topical 5-flourouracil in Treatment of Vitillgo Patients

An interventional study of derma pen in Vitiligo, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Vitiligo is a depigmenting skin disorder, characterized by the selective loss of melanocytes, which in turn leads to loss of pigment in the affected areas of the skin It considerd as autoimmune disease, associated with genetic and environmental factors together with metabolic, oxidative stress and cell detachment abnormalities The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic . with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide 5-Flourouracil is an antimetabolite analogue of the naturally occurring pyrimidine uracil which is metabolised via the same metabolic pathways as uracil Due to its antimitotic activity, topical 5-Flourouracil is a useful therapy for the treatment of many dermatological disorders characterized by a high mitotic rate Clinically, localized hyperpigmentations have been reported during systemic treatment of various cancers by 5-Flourouracil. Usually, these hyperpigmented lesions are located on the normally pigmented extremities (hands and feet) and tongue.

Methotrexate as an antimetabolite and antifolate drug is a time-tested effective treatment extensively used in various autoimmune disorders in low to moderate doses with good efficacy, safety, and tolerability on a long-term basis .

Methotrexate treatment resulted in the decrease of the number of TNF-α-producing T cells, whereas the number of T cells producing IL-10 after polyclonal activation increased, in another study .

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Conditions studied

  • Vitiligo

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03

In context

Vitiligo

298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.

This study's enrollment of 30 is close to the median of 30 across 227 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

    • Age :main 18 and above years old.

      • Stable vitiligo (each patient has 3separated patches of depigmentation at least).

Exclusion Criteria:• History of keloid formation.

  • Patients with systemic diseases (diabetes, bleeding disorders)
  • Patients who are receiving chemotherapy or radiotherapy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    vitillgo patients

    Device: derma pen

Interventions

  • Devicederma pen

    Derma pen is automatic and rechargeable device (vibrating frequency:6500-10000 r/m, vibration speed level 5, model: Ultima A6, company: Dr. Pen and country: Korea). With every case the needle should be replaced. Needle length is adjustable from 0.25mm to 2mm according to the treated areas. The pen is convenient in treating narrow areas such as the nose, around the eye and the mouth. The vibration speed of the pen can be controlled in 5 levels

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What researchers measure

Primary outcomes

  1. percentage of repigmentation

    dermoscopic evaluation

    Time frame: 6 months

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Study locations

1 site
  • Sohag University Hospital
    Sohag, Egypt
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References and documents

Publications

  • Picardo M, Dell'Anna ML, Ezzedine K, Hamzavi I, Harris JE, Parsad D, Taieb A. Vitiligo. Nat Rev Dis Primers. 2015 Jun 4;1:15011. doi: 10.1038/nrdp.2015.11. PubMed 27189851 ↗
  • Kruger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012 Oct;51(10):1206-12. doi: 10.1111/j.1365-4632.2011.05377.x. Epub 2012 Mar 27. PubMed 22458952 ↗
  • Feily A. Vitiligo Extent Tensity Index (VETI) score: a new definition, assessment and treatment evaluation criteria in vitiligo. Dermatol Pract Concept. 2014 Oct 31;4(4):81-4. doi: 10.5826/dpc.0404a18. eCollection 2014 Oct. PubMed 25396094 ↗
  • Ezzedine K, Lim HW, Suzuki T, Katayama I, Hamzavi I, Lan CC, Goh BK, Anbar T, Silva de Castro C, Lee AY, Parsad D, van Geel N, Le Poole IC, Oiso N, Benzekri L, Spritz R, Gauthier Y, Hann SK, Picardo M, Taieb A; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012 May;25(3):E1-13. doi: 10.1111/j.1755-148X.2012.00997.x. PubMed 22417114 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, 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
NCT05467839
Lead sponsor
Sohag University
Responsible party
Fatma Kassem Ali (Resident of dermatology and venerology at Sohag general hospital, Sohag University) — Principal investigator
First posted
Jul 21, 2022
Start date
Jul 31, 2022
Primary completion
Oct 20, 2022
Completion
Jan 30, 2023
Last update
Oct 26, 2024

Oversight

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

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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