Evaluating the Efficacy and Safety of 4% 5-Fluorouracil Cream in Patients with Actinic Keratosis: An Expert Opinion

Stockfleth E, Heppt M, Bégeault N, Delarue A (2023)

Publication Type: Journal article

Publication year: 2023

Journal

Acta Dermato-Venereologica Society for Publication of Acta Dermato-Venereologica

Book Volume: 103

Pages Range: adv11954-

DOI: 10.2340/actadv.v103.11954

Abstract

Actinic keratosis is a lesion that develops in sun-exposed areas of the skin and is considered to be a precancerous condition or an early in situ squamous cell carcinoma. Treatment of actinic keratosis is important for reducing skin cancer risk, with treatment choice based on patient-, lesion- and treatment-related considerations. Of the topical treatments used for field-directed therapy, those containing 5-fluorouracil are among the most effective and widely prescribed. The most recently developed topical 5-fluorouracil preparation (Tolak®; Pierre Fabre, France) contains 4% 5-fluorouracil in an aqueous cream. This narrative review discusses data on 4% 5-fluorouracil cream to treat actinic keratosis, and provides the authors' expert opinion on issues associated with it use. The effect of the cream has been evaluated in phase 2 and 3 trials of adult patients with actinic keratosis on the face, ears or scalp. These trials included patients with severe baseline disease, defined by high lesion counts and large-size treatment fields, which possibly affected the proportion of patients who were able to achieve complete clearance. Other efficacy parameters (e.g. percentage change in lesion count, ≥ 75% clearance of lesions or clinically significant changes in validated severity scales) should also be assessed to fully evaluate 4% 5-fluorouracil treatment efficacy in these patients. Nevertheless, 4% 5-fluorouracil is associated with high efficacy, a low level of recurrence and a satisfactory safety profile.

Authors with CRIS profile

Markus Heppt Department of Dermatology

Involved external institutions

Pierre Fabre S.A FR France (FR) Ruhr-Universität Bochum (RUB) DE Germany (DE)

How to cite

APA:

Stockfleth, E., Heppt, M., Bégeault, N., & Delarue, A. (2023). Evaluating the Efficacy and Safety of 4% 5-Fluorouracil Cream in Patients with Actinic Keratosis: An Expert Opinion. Acta Dermato-Venereologica, 103, adv11954-. https://doi.org/10.2340/actadv.v103.11954

MLA:

Stockfleth, Eggert, et al. "Evaluating the Efficacy and Safety of 4% 5-Fluorouracil Cream in Patients with Actinic Keratosis: An Expert Opinion." Acta Dermato-Venereologica 103 (2023): adv11954-.

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