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

**Authors:** Carmen Cantisani, Antonio Di Guardo, Giovanni Paolino, Natasa Balázs, Mehdi Boostani, Norbert Kiss, Claudio Conforti, Francesca Feresin, Andrea Carugno, Luca Gargano, Luigi Losco, Steven Paul Nisticò, Giovanni Pellacani

PMC · DOI: 10.3390/jcm15020612 · 2026-01-12

## TL;DR

This study shows that 4% 5-fluorouracil cream is effective and safe for treating actinic keratoses, with most patients achieving complete clearance.

## Contribution

The study provides real-world evidence of 4% 5-FU cream efficacy and safety in treating actinic keratoses.

## Key findings

- 92% of patients achieved complete clearance of actinic keratoses with 4% 5-FU cream.
- 8% of patients showed at least 75% reduction in lesion count (partial clearance).
- The recurrence rate at 12 months was 11%.

## 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.

## Linked entities

- **Chemicals:** 5-fluorouracil (PubChem CID 3385), 5-FU (PubChem CID 3385)
- **Diseases:** squamous cell carcinoma (MONDO:0005096)

## Full-text entities

- **Diseases:** melanoma skin cancer (MESH:D012878), SCC (MESH:D002294), solar keratoses (MESH:D007642), skin lesions (MESH:D012871), AKs (MESH:D055623)
- **Chemicals:** 5-Fluorouracil Cream (-), 5-FU (MESH:D005472)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Figures

4 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12842186/full.md

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Source: https://tomesphere.com/paper/PMC12842186