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

July 7, 2023 updated by: Amal Mohamed Abdelaziz Ashour, South Valley University

Efficacy of Topical 5-fluorouracil Versus Topical Latanoprost With Microneedling in Localized Stable Vitiligo: A Randomised Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitiligo is an acquired pigmentary disorder characterized by depigmented macules and patches secondary to the loss of functional melanocytes. It is a chronic disease that affects between 0.1% and 2% of the general population, affecting both sexes and all races.

Theories regarding loss of melanocytes are based on autoimmune, cytotoxic, oxidant-antioxidant and neural mechanisms.

Therapeutic strategies for vitiligo include nonsurgical and surgical methods. Nonsurgical options include topical corticosteroids and topical calcineurin inhibitors. Phototherapy as psoralen and ultraviolet A (PUVA) and narrow-band ultraviolet B (NB-UVB).

Two types of surgical techniques are available: tissue grafts and cellular grafts, within between autologous cultured epithelial grafts.

Microneedling is a method of transdermal drug delivery using a microneedling device applied to the skin for creating transport pathways through the stratum corneum, increasing the absorption of drugs and decreasing the duration of therapy. In addition, microneedling keeps the epidermis partially intact, fastens recovery, and limits the risk of infection and scarring. 5-Fluorouracil (5-FU) is a chemotherapeutic agent used in the treatment of many malignant tumors and it has been approved for topical use in the treatment of several dermatologic disorders. Localized hyperpigmentation occurred as a side effect of 5-FU use in cancer treatment attracts the attention toward its application in inducing repigmentation in vitiligo patches.

Latanoprost (LT), a prostaglandin F2 alpha analogue used in the treatment of glaucoma, was found to induce skin pigmentation in guinea pigs in addition to its known periocular and iridal pigmentation side effect.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qena Governorate
      • Qinā, Qena Governorate, Egypt, 83523
        • South Valley University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both sexes with stable localized vitiligo : patches should not have any increase or decrease in size or pigmentation for at least 3 months.

Exclusion Criteria:

  • Pregnant or lactating female.
  • Active Koebner's phenomenon.
  • Age less than 10 years.
  • All patients included had not received any local or systemic medication for at least 2 months before the study.
  • Keloidal tendency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (topical latanoprost)
20 vitiligo patients will receive topical latanoprost solution (the concentration of the solution is 0.005%, pharmaceutically available eye-drop formulation)
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.

Other Names:
  • Microneedling using Dr Pen Derma Pen Ultima A6®
Active Comparator: Group B (topical 5-fluorouracil)
20 vitiligo patients will receive topical 5-fluorouracil 5% solution available as ampoules (Utoral®, EIMC United Pharmaceuticals, Egypt)
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.

Other Names:
  • Microneedling using Dr Pen Derma Pen Ultima A6®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of clinical repigmentation changes of vitiligo lesions according to Physician's Global Assessment [PGA]
Time Frame: 6 months
5 scales are : G4 (excellent: >75% repigmentation) G3 (very good: 50%-75% repigmentation) G2 (good: 25%-50%) G1 (satisfactory: <25% repigmentation) G0 (poor: no repigmentation)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Study Chair: Hassan M Ibrahim, professor, South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

August 20, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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