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VitiligoPhase 2/3NCT05513924

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

A Phase 2/3 study testing Latanoprost 0.005% Ophthalmic Solution and 5Fluorouracil in people with Vitiligo, run by South Valley University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 60 years
Conditions the study is for
Vitiligo
What is being tested?
Latanoprost 0.005% Ophthalmic Solution and 5Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
15 Mar 2022to 1 Dec 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • South Valley University

    Qina, Qena Governorate, 83523

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Conditions
Vitiligo
Being tested
Latanoprost 0.005% Ophthalmic Solution, 5Fluorouracil
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Latanoprost 0.005% Ophthalmic SolutionDrug

    Also called Microneedling using Dr Pen Derma Pen Ultima A6®

    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.

  • 5FluorouracilDrug

    Also called Microneedling using Dr Pen Derma Pen Ultima A6®

    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.

Study groups in NCT05513924
Study groupRoleWhat they receive
Group A (topical latanoprost)Active comparator20 vitiligo patients will receive topical latanoprost solution (the concentration of the solution is 0.005%, pharmaceutically available eye-drop formulation)
Receives: Drug: Latanoprost 0.005% Ophthalmic Solution
Group B (topical 5-fluorouracil)Active comparator20 vitiligo patients will receive topical 5-fluorouracil 5% solution available as ampoules (Utoral®, EIMC United Pharmaceuticals, Egypt)
Receives: Drug: 5Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start15 Mar 2022
  3. Primary completion1 Nov 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05513924
Sponsor's protocol ID
370
Status last verified
Jul 2023
First submitted
20 Aug 2022
Last updated
11 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22423621

  • 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.

    PubMed 23425123

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

    PubMed 11306848

  • 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.

    PubMed 15019747

  • 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.

    PubMed 30187924

  • 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.

    PubMed 25549816

  • 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.

    PubMed 25545321

  • 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.

    PubMed 18002737

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Latanoprost 0.005% Ophthalmic Solution and 5Fluorouracil in people with Vitiligo, run by South Valley University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of clinical repigmentation changes of vitiligo lesions according to Physician's Global Assessment [PGA] (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05513924, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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