Real-World Experience with Topical 5-Fluorouracil 4% (40 mg/g) Cream for the Treatment of Actinic Keratosis

Citation: Briatico G, Brancaccio G, Scharf C, et al. Real-world experience with topical 5-fluorouracil 4% (40 mg/g) cream for the treatment of actinic keratosis. Dermatol Pract Concept. 2023;13(2):e2023151. DOI: https://doi.org/10.5826/dpc.1302a151

Accepted: November 30, 2023; Published: April 2023

Copyright: ©2023 Briatico et al. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (BY-NC-4.0), https://creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original authors and source are credited.

Funding: None.

Competing interests: None.

Authorship: All authors have contributed significantly to this publication.

Corresponding author: Giulia Briatico, Dermatology Unit, University of Campania, Via Pansini, 5, 80131, Naples, Italy, giuliabriatico@gmail.com

Abstract

Introduction:5-fluorouracil (5-FU) is one of the most effective topical treatments for actinic keratosis (AK). A new 4% formulation of 5-FU was recently approved in Europe.

Objectives:This study aimed at evaluating 4% 5-FU cream safety and effectiveness in a real-world setting.

Methods:Adult AK patients were retrospectively selected from the University of Campania Dermatology Unit database. Selection criteria included a diagnosis of non-hyperkeratotic, non-hypertrophic AK (Olsen grade I and II) of the face, ears, and/or scalp, treatment with 4% 5-FU once daily for 4 weeks, and at least 3 follow-up visits (4 and 8 weeks after treatment initiation, and 6 months after treatment end). The primary objectives were to evaluate AK lesions improvement at 8 weeks and relapse rate at 6 months. Patient-reported erythema and burning sensation intensity were also assessed at 4 weeks.

Results: Ninety-eight patients were included in this analysis (male/female 80/18, mean age 74.7 years). AK lesions improvement at 8 weeks resulted complete or significant in 74.5% and 20.4% of the patients, respectively. At 6 months, 65.3% of the patients did not show AK relapses. Burning sensation at 4 weeks was reported as light, moderate, or absent by 44.9%, 22.4%, and 31.6% of the patients, respectively. Erythema was reported as light, moderate, or absent by 37.8%, 51%, and 10% of the patients, respectively. Burning sensation and erythema disappeared gradually during follow-up. No other side effects were reported.

Conclusions:In this real-world study 4% 5-FU proved to be highly effective for AK lesions clearance with a favorable safety profile.

Keywords : actinic keratosis, 5-fluorouracil, treatment, efficacy, safety

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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