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

• Main Authors: Giulia Briatico (Author), Gabriella Brancaccio (Author), Camila Scharf (Author), Eugenia Veronica Di Brizzi (Author), Sebastiano Pellerone (Author), Stefano Caccavale (Author), Caterina Mariarosaria Giorgio (Author), Enrico Maria Procaccini (Author), Elvira Moscarella (Author), Giuseppe Argenziano (Author)
• Format: Book
• Published: Mattioli1885, 2023-04-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

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.

Item Description

10.5826/dpc.1302a151
2160-9381