NCT05467839

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

July 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

July 4, 2022

Last Update Submit

October 22, 2024

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • percentage of repigmentation

    dermoscopic evaluation

    6 months

Study Arms (1)

vitillgo patients

EXPERIMENTAL
Device: derma pen

Interventions

derma penDEVICE

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

vitillgo patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age :main 18 and above years old.
  • Stable vitiligo (each patient has 3separated patches of depigmentation at least).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 27189851BACKGROUND

  • 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.

    PMID: 22458952BACKGROUND

  • 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.

    PMID: 25396094BACKGROUND

  • 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.

    PMID: 22417114BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of dermatology and venerology at Sohag general hospital

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 21, 2022

Study Start

July 31, 2022

Primary Completion

October 20, 2022

Study Completion

January 30, 2023

Last Updated

October 26, 2024

Record last verified: 2024-10

Locations

EG(1)