NCT05513924

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

August 20, 2022

Last Update Submit

July 7, 2023

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • Assessment of clinical repigmentation changes of vitiligo lesions according to Physician's Global Assessment [PGA]

    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

Study Arms (2)

Group A (topical latanoprost)

ACTIVE COMPARATOR

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

Group B (topical 5-fluorouracil)

ACTIVE COMPARATOR

20 vitiligo patients will receive topical 5-fluorouracil 5% solution available as ampoules (Utoral®, EIMC United Pharmaceuticals, Egypt)

Drug: 5Fluorouracil

Interventions

Latanoprost 0.005% Ophthalmic SolutionDRUG

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.

Also known as: Microneedling using Dr Pen Derma Pen Ultima A6®
Group A (topical latanoprost)
5FluorouracilDRUG

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.

Also known as: Microneedling using Dr Pen Derma Pen Ultima A6®
Group B (topical 5-fluorouracil)

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (8)

  • Bacigalupi RM, Postolova A, Davis RS. Evidence-based, non-surgical treatments for vitiligo: a review. Am J Clin Dermatol. 2012 Aug 1;13(4):217-37. doi: 10.2165/11630540-000000000-00000.

    PMID: 22423621BACKGROUND

  • Laddha NC, Dwivedi M, Mansuri MS, Gani AR, Ansarullah M, Ramachandran AV, Dalai S, Begum R. Vitiligo: interplay between oxidative stress and immune system. Exp Dermatol. 2013 Apr;22(4):245-50. doi: 10.1111/exd.12103. Epub 2013 Feb 21.

    PMID: 23425123BACKGROUND

  • van Geel N, Ongenae K, Naeyaert JM. Surgical techniques for vitiligo: a review. Dermatology. 2001;202(2):162-6. doi: 10.1159/000051626.

    PMID: 11306848BACKGROUND

  • Prausnitz MR. Microneedles for transdermal drug delivery. Adv Drug Deliv Rev. 2004 Mar 27;56(5):581-7. doi: 10.1016/j.addr.2003.10.023.

    PMID: 15019747BACKGROUND

  • Prince GT, Cameron MC, Fathi R, Alkousakis T. Topical 5-fluorouracil in dermatologic disease. Int J Dermatol. 2018 Oct;57(10):1259-1264. doi: 10.1111/ijd.14106. Epub 2018 Jun 25.

    PMID: 30187924BACKGROUND

  • Mohamed HA, Mohammed GF, Gomaa AH, Eyada MM. Carbon dioxide laser plus topical 5-fluorouracil: a new combination therapeutic modality for acral vitiligo. J Cosmet Laser Ther. 2015;17(4):216-23. doi: 10.3109/14764172.2014.1003241. Epub 2015 Jan 30.

    PMID: 25549816BACKGROUND

  • Anbar TS, El-Ammawi TS, Abdel-Rahman AT, Hanna MR. The effect of latanoprost on vitiligo: a preliminary comparative study. Int J Dermatol. 2015;54(5):587-93. doi: 10.1111/ijd.12631. Epub 2014 Dec 29.

    PMID: 25545321BACKGROUND

  • Nugroho H, Fadzil MH, Yap VV, Norashikin S, Suraiya HH. Determination of skin repigmentation progression. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:3442-5. doi: 10.1109/IEMBS.2007.4353071.

    PMID: 18002737BACKGROUND

MeSH Terms

Conditions

Vitiligo

Interventions

LatanoprostOphthalmic SolutionsFluorouracil

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hassan M Ibrahim, professor

    South Valley University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2022

First Posted

August 24, 2022

Study Start

March 15, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)