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. 2023 May 28;15(11):2956.
doi: 10.3390/cancers15112956.

Actinic Keratoses: A Prospective Pilot Study on a Novel Formulation of 4% 5-Fluorouracil Cream and a Review of Other Current Topical Treatment Options

Ludovica Toffoli  1 , Caterina Dianzani  2 , Serena Bonin  3 , Claudio Guarneri  4 , Fabrizio Guarneri  5 , Roberta Giuffrida  5 , Iris Zalaudek  1 , Claudio Conforti  1
Affiliations

Actinic Keratoses: A Prospective Pilot Study on a Novel Formulation of 4% 5-Fluorouracil Cream and a Review of Other Current Topical Treatment Options

Ludovica Toffoli et al. Cancers (Basel). .

Abstract

Background: Actinic keratosis (AK) is one of the most common skin diseases, with a low risk of progression into invasive squamous cell carcinoma. We aim to assess efficacy and safety of a novel formulation of 5-Fluorouracil (5-FU) 4% with once daily application for the treatment of multiple AKs.

Methods: A pilot study was performed on 30 patients with a clinical and dermoscopic diagnosis of multiple AKs, enrolled between September 2021 and May 2022 at the Dermatology Departments of two Italian hospitals. Patients were treated with 5-FU 4% cream once daily for 30 consecutive days. The Actinic Keratosis Area and Severity Index (AKASI) was calculated before starting therapy, and at each follow-up, to assess objective clinical response.

Results: The cohort analyzed included 14 (47%) males and 16 (53%) females (mean age: 71 ± 12 years). A significant decrease in AKASI score at both 6 and 12 weeks (p < 0.0001) was observed. Only three patients (10%) discontinued therapy, and 13 patients (43%) did not report any adverse reactions; no unexpected adverse events were observed.

Conclusions: In the setting of topical chemotherapy and immunotherapy, the new formulation of 5-FU 4% proved to be a highly effective treatment for AKs and field cancerization.

Keywords: 5-Fluorouracil; actinic keratosis; dermoscopy; non-melanoma skin cancer; skin cancer; therapy.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Box-plot representing the Actinic Keratosis Area and Severity Index (AKASI) score at different time points, namely, before and after six and twelve weeks of treatment. A one-way repeated measures ANOVA was run on a sample of 30 patients to determine if there were differences in AKASI score due to treatment with 5-FU 4% cream. The results showed that the treatment elicited statistically significant differences in mean AKASI score over its time course, F (2, 53) = 35.7, p < 0.0001.
Figure 2
Figure 2
Example of complete dermoscopic clearance at week 12. (A) Baseline dermoscopic features of AK: erythematous background with yellowish scales. (B) Dermoscopic disappearance of AK features at week 12.
Figure 3
Figure 3
Example of patient with more than six actinic keratoses on the face treated with 4% 5-Fluorouracil cream. (A,B) Clinical presentation of multiple AKs before treatment. (C,D) Common side effects with 5-FU 4% cream: erosion, erythema and scabs. (E,F) Complete response after six weeks of treatment.
See this image and copyright information in PMC

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