Association Between Local Skin Reactions and Efficacy with 5-Fluorouracil 4% Cream in Actinic Keratosis: A Post-Hoc Analysis of Two Randomised Clinical Trials.

ABSTRACT:

Introduction

Topical 5-fluorouracil (5-FU), 5% or 4% cream, is recommended among first-line treatments for actinic keratosis (AK). Local skin reactions (LSRs) are an expected and transient response to treatment with 5-FU but can lead to treatment discontinuation when severe. This analysis aimed to investigate whether the severity of LSRs during the treatment was associated with lesion clearance assessed 4 weeks after completing treatment.

Methods

This post hoc analysis pooled data from two randomised clinical trials (HD-FUP3B-048 and HD-FUP3B-049). Only patients treated with once-daily 5-FU 4% for 4 weeks were considered. Analyses included LSR severity at week 2 and 4 and clearance 4 weeks after completing treatment (week 8). Analysed LSRs were erythema, scaling, oedema, cru

SUBMITTER: Heppt MV 

PROVIDER: S-EPMC11833037 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature