Efﬁcacy of 4% 5-Fluorouracil Cream in the Treatment of Actinic Keratoses - A Single-Center Experience

Sep 22, 2026

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Retrospective single-center analysis assessed clinical outcomes and safety of 4% 5-fluorouracil (5-FU) cream in patients with actinic keratoses (AKs), also called solar keratoses. The study evaluated 150 patients with 432 lesions, using complete clearance as the primary efficacy measure and partial clearance (≥75% lesion count reduction) as a secondary measure. Complete clearance occurred in 92% of patients and partial clearance in 8%, with 11% recurrence at 12 months. Findings support 4% 5-FU as effective and well tolerated, particularly for extensive field cancerization.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages14

Reading Time35 min

AccessFree to download

Abstract

Background/Objectives

Methods

Results

Conclusions

Keywords

1. Introduction

Epidemiology and risk factors

Mechanism of action of 5-FU

Related treatment options

Article Efﬁcacy of 4% 5-Fluorouracil Cream in the Treatment of Actinic Keratoses: A Single-Center Experience Carmen Cantisani 1, *, Antonio Di Guardo 1,2, Giovanni Paolino 3, Natasa Balázs 4, Mehdi Boostani 4,5, Norbert Kiss 4, Claudio Conforti 2, Francesca Feresin 1, Andrea Carugno 6, Luca Gargano 1, Luigi Losco 7, Steven Paul Nisticá 1 and Giovanni Pellacani 1 Academic Editors: Alexander C. Katoulis and Alan Fleischer Received: 1 October 2025 Revised: 27 December 2025 Accepted: 8 January 2026 Published: 12 January 2026 Copyright: © 2026 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. 1 UOC of Dermatology, Department of Clinical and Cardiovascular Sciences,“Sapienza” University of Rome, 00185 Rome, Italy; [antonio.diguardo@uniroma1.it](antonio.diguardo@uniroma1.it) (A.D.G.); [feresinfrancesca@gmail.com](feresinfrancesca@gmail.com) (F.F.); [lucagargano1995@gmail.com](lucagargano1995@gmail.com) (L.G.); [steven.nistico@gmail.com](steven.nistico@gmail.com) (S.P.N.); [pellacani.giovanni@gmail.com](pellacani.giovanni@gmail.com) (G.P.) 2 IDI-IRCCS, Dermatological Research Hospital, 00167 Rome, Italy; [c.conforti@unilink.it](c.conforti@unilink.it) 3 Unit of Dermatology, IRCCS San Raffaele Hospital, 20132 Milan, Italy; [gio8519@gmail.com](gio8519@gmail.com) 4 Department of Dermatology, Venereology and Dermatooncology, Semmelweis University, 1085 Budapest, Hungary; [natasabalaz75@gmail.com](natasabalaz75@gmail.com) (N.B.); [mehdi_parsii@yahoo.com](mehdi_parsii@yahoo.com) (M.B.); [norbert.f.kiss@gmail.com](norbert.f.kiss@gmail.com) (N.K.) 5 Department of Dermatology, Roswell Park Comprehensive Cancer Center, Buffalo, NY 14203, USA 6 Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy; [andrea.carugno@uninsubria.it](andrea.carugno@uninsubria.it) 7 Department of Medicine, Surgery and Dentistry, University of Salerno, 84081 Baronissi, Italy; [luigi.losco@gmail.com](luigi.losco@gmail.com) * Correspondence: [carmen.cantisani@uniroma1.it](carmen.cantisani@uniroma1.it); Tel.: +39-30649976993 Abstract Background/Objectives: Actinic keratoses (AKs), also known as solar keratoses, are considered premalignant skin lesions that can evolve into squamous cell carcinoma (SCC) . Among the available options, 5-ﬂuorouracil (5-FU) remains a cornerstone. Methods: This study is a retrospective analysis of our database of the non-melanoma skin cancer outpatient clinic. The main objective was to evaluate patients treated with 4% 5-FU cream for AK lesions. The efﬁcacy of 4% 5-FU was evaluated retrospectively by measuring the percentage of patients who achieved complete clearance. A secondary efﬁcacy measure was the percentage of partial clearance, deﬁned as at least a 75% reduction in lesion count. Additionally, the study aimed to assess the safety of 4% 5-FU cream. Results: We included 150 patients clinically diagnosed with AK, treated with 4% 5-FU cream and evaluated 432 lesions. Complete clearance of lesions was observed in 138 patients (92%) with partial clearance in 12 patients (8%) . At 12 months, the recurrence rate was 11% . Conclusions: Based on our analysis, 4% 5-FU cream is an effective and well-tolerated treatment for AKs, particularly in patients with extensive ﬁeld cancerization. While local skin reactions are a natural part of its mechanism, they are manageable and do not outweigh clinical beneﬁts. Keywords: actinic keratosis; 5 ﬂuorouracil; local skin reactions; non-melanoma skin cancer 1. Introduction Actinic keratoses (AKs), also known as solar keratoses, are among the most common premalignant skin lesions worldwide [1,2] . Their incidence continues to rise, making thema signiﬁcant public health concern due to their potential to progress into invasive squamous cell carcinoma (iSCC) . The prevalence of AKs increases with age and cumulative

FAQs

What was the main objective of the study on 4% 5-FU cream?

To evaluate patients treated with 4% 5-FU cream for actinic keratosis lesions and measure efficacy by the percentage achieving complete clearance.

How were efficacy outcomes defined and measured?

Complete clearance was the primary efficacy measure, while partial clearance was defined as at least a 75% reduction in lesion count.

What were the key efficacy results and recurrence rate at 12 months?

Complete clearance was observed in 92% of patients and partial clearance in 8%. The recurrence rate at 12 months was 11%.

Sep 22, 2026

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