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Comparative Study Between Topical 5-fluorouracil and Latanoprost in Vitiligo.

NCT05513924 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-07-11

No results posted yet for this study

Summary

This study aims to compare the efficacy of topical 5-fluorouracil versus topical latanoprost after skin microneedling in the induction of skin repigmentation in localized stable vitiligo patients.

Conditions

  • Vitiligo

Interventions

DRUG

Latanoprost 0.005% Ophthalmic Solution

The affected area cleaned with betadine surgical solution followed by alcohol 70%. Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure. Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session. The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears. The LT solution will be applied immediately to vitiligo patch one drop (contains 1.5 μg of LT) for every 2.5 cm. This procedure will be repeated every two weeks for six months.

DRUG

5Fluorouracil

The affected area cleaned with betadine surgical solution followed by alcohol 70%. Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure. Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session. The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears. Topical application of 5-fluorouracil 5% solution will be rubbed over the affected area for about 2 minutes. Occlusive dressing for hours. This procedure will be repeated every two weeks for six months.

Sponsors & Collaborators

  • South Valley University

    lead OTHER

Principal Investigators

  • Hassan M Ibrahim, professor · South Valley University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2022-11-01
Completion
2022-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513924 on ClinicalTrials.gov