Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 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.

PubMed Disclaimer

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

Similar articles

See all similar articles

Cited by

References

    1. de Oliveira E.C.V., da Motta V.R.V., Pantoja P.C., Ilha d.O.C.S., Magalhães R.F., Galadari H., Leonardi G.R. Actinic Keratosis—Review for Clinical Practice. Int. J. Dermatol. 2019;58:400–407. doi: 10.1111/ijd.14147. - DOI - PubMed
    1. Olsen E.A., Lisa Abernethy M., Kulp-Shorten C., Callen J.P., Glazer S.D., Huntley A., McCray M., Monroe A.B., Tschen E., Wolf J.E. A Double-Blind, Vehicle-Controlled Study Evaluating Masoprocol Cream in the Treatment of Actinic Keratoses on the Head and Neck. J. Am. Acad. Dermatol. 1991;24:738–743. doi: 10.1016/0190-9622(91)70113-G. - DOI - PubMed
    1. Del Regno L., Catapano S., Di Stefani A., Cappilli S., Peris K. A Review of Existing Therapies for Actinic Keratosis: Current Status and Future Directions. Am. J. Clin. Dermatol. 2022;23:339–352. doi: 10.1007/s40257-022-00674-3. - DOI - PMC - PubMed
    1. Conforti C., Giuffrida R., Dianzani C., Guarneri F., Marangi G.F., Neagu N., Persichetti P., Zalaudek I., di Meo N. Effectiveness and Tolerability of Treatment for Isolated Actinic Keratoses: A Retrospective Comparison between Cryotherapy, CO2 Laser and 5-Fluorouracil 0.5%/Salicylic Acid 10% Dermatol. Ther. 2021;34:e14846. doi: 10.1111/dth.14846. - DOI - PubMed
    1. Dianzani C., Conforti C., Giuffrida R., Corneli P., di Meo N., Farinazzo E., Moret A., Magaton Rizzi G., Zalaudek I. Current Therapies for Actinic Keratosis. Int. J. Dermatol. 2020;59:677–684. doi: 10.1111/ijd.14767. - DOI - PubMed

LinkOut - more resources