NCT05467839

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

Completed NA Last updated 26 October 2024

What this trial tests

NA trial testing derma pen in Vitiligo in 30 participants. Completed in 30 January 2023.

Timeline

31 July 2022

Primary endpoint
20 October 2022

30 January 2023

Quick facts

Lead sponsor	Sohag University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	31 July 2022
Primary completion	20 October 2022
Estimated completion	30 January 2023
Sites	1 location across Egypt

Drugs / interventions tested

• derma pen

Conditions studied

• Vitiligo — all drugs for Vitiligo →

Sponsor

Sohag University

Who can join

18 and older, any sex, with Vitiligo. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 .

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advances of microneedle technology for the treatment of autoimmune diseases.
   Chen Y, Fu Y, Wen X, Chen M, et al · · 2026 · cited 1× · PMID 42039282 · DOI 10.1016/j.apsb.2026.01.003