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

Sponsor
South Valley University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05513924
Collaborator
(none)
40
1
2
8.6
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Topical 5-fluorouracil Versus Topical Latanoprost With Microneedling in Localized Stable Vitiligo: A Randomised Clinical Trial
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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®
  • Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Valley University Qinā Qena Governorate Egypt 83523

    Sponsors and Collaborators

    • South Valley University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amal Mohamed Abdelaziz Ashour, Principal Investigator, South Valley University
    ClinicalTrials.gov Identifier:
    NCT05513924
    Other Study ID Numbers:
    • 370
    First Posted:
    Aug 24, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022