Efficacy of 5-Fluorouracil 4% Cream in the Treatment of Hyperkeratotic Actinic Keratosis: A Single-Center Retrospective Real-World Study.

IF 4.2 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-10-01 Epub Date: 2025-08-16 DOI:10.1007/s13555-025-01518-8

Federica Li Pomi, Andrea d'Aloja, Marta Vitale, Michelangelo Rottura, Natasha Irrera, Mario Vaccaro, Francesco Borgia

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引用次数: 0

Abstract

Introduction: Actinic keratosis (AK) is recognized as the main precursor of cutaneous squamous cell carcinoma (cSCC). Given the unpredictable potential for progression, current guidelines recommend treating all AKs, irrespective of their clinical grade. However, many approved treatments are not indicated for hyperkeratotic AKs. Among topical therapies, 5-fluorouracil (5-FU) 4% cream (Tolak®/Tolerak®; Pierre Fabre) is a chemotherapeutic agent that has shown excellent results in treating non-hyperkeratotic AKs on the face, ear, and scalp, both in clinical trials and real-life experiences. However, its effectiveness in managing hyperkeratotic AKs remains unexplored.

Methods: A retrospective, single-center study was conducted at the Dermatology Unit of the University of Messina, Italy, between September 2024 and March 2025. The study included 66 hyperkeratotic AK lesions in 19 consecutive patients, treated with 5-FU cream for 28 consecutive days.

Results: At the 3-month follow-up, total clearance (complete lesion resolution) was observed in 54.5% of hyperkeratotic lesions, while partial clearance (> 75% lesion reduction) was recorded in 24.2%. The treatment demonstrated a good safety profile, with good patient tolerability. Among local skin reactions (LSRs), erythema was the most frequently observed, occurring in 89.5% of patients, followed by stinging, which was reported in 73.6% of cases. No patient discontinued the treatment as a result of the onset of adverse events.

Conclusions: Our findings, albeit initial, support the efficacy and safety of 5-FU 4% cream for the treatment of hyperkeratotic AKs.

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5-氟尿嘧啶4%乳膏治疗过度角化性光化性角化病的疗效：一项单中心回顾性真实世界研究

光化性角化病（AK）被认为是皮肤鳞状细胞癌（cSCC）的主要前兆。鉴于不可预测的进展可能性，目前的指南建议治疗所有的AKs，无论其临床分级如何。然而，许多已批准的治疗方法并不适用于角化过度的ak。在局部治疗中，5-氟尿嘧啶（5-FU） 4%乳膏(Tolak®/Tolerak®；皮埃尔法布尔（Pierre Fabre）是一种化疗药物，在治疗面部、耳朵和头皮上的非角化性AKs方面显示出极好的效果，无论是在临床试验还是在现实生活中。然而，它在治疗角化过度的ak中的有效性仍未被探索。方法：回顾性、单中心研究于2024年9月至2025年3月在意大利墨西拿大学皮肤科进行。研究纳入66例AK角化过度病变患者，连续19例，用5-FU乳膏治疗28天。结果：在3个月的随访中，54.5%的角化过度病变完全清除（病灶完全消退），24.2%的角化过度病变部分清除（病灶缩小75%）。该治疗显示出良好的安全性，患者耐受性良好。在局部皮肤反应（LSRs）中，最常见的是红斑，发生率为89.5%，其次是刺痛，发生率为73.6%。没有患者因出现不良事件而停止治疗。结论：我们的研究结果，虽然是初步的，但支持5-FU 4%乳膏治疗角化过度性AKs的有效性和安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.