NCT05467839

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Vitiligo

Interventions

Type	Name	Description
DEVICE	derma 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

Timeline

• Start date: 2022-07-31
• Primary completion: 2022-10-20
• Completion: 2023-01-30
• First posted: 2022-07-21
• Last updated: 2024-10-26

Locations

1 site across 1 country: Egypt