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

NCT ID: NCT05467839

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-01-30

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 .

Conditions

Vitiligo

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vitillgo patients

Group Type: EXPERIMENTAL

derma pen

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• • Age :main 18 and above years old.

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Kassem Ali

Resident of dermatology and venerology at Sohag general hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 27189851 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22458952 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25396094 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22417114 (View on PubMed)

Other Identifiers

soh-med-22-05-10

Identifier Type: -

Identifier Source: org_study_id