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

Phase 2

Completed

• Conditions: Vitiligo
• Interventions: Drug: Latanoprost 0.005% Ophthalmic Solution; Drug: 5Fluorouracil

• Registration Number: NCT05513924
• Lead Sponsor: South Valley University

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.

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 Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-08-20
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (topical latanoprost)	Latanoprost 0.005% Ophthalmic Solution	20 vitiligo patients will receive topical latanoprost solution (the concentration of the solution is 0.005%, pharmaceutically available eye-drop formulation)
Group B (topical 5-fluorouracil)	5Fluorouracil	20 vitiligo patients will receive topical 5-fluorouracil 5% solution available as ampoules (Utoral®, EIMC United Pharmaceuticals, Egypt)

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

South Valley University; 🇪🇬 Qinā, Qena Governorate, Egypt