Efﬁcacy and safety of 0.5% colchicine cream versus 5% 5-fluorouracil cream in the treatment of cutaneous ﬁeld cancerization: a randomized clinical trial

Sep 21, 2026

Uploaded by Maeve

Randomized open self-controlled trial evaluating 0.5% colchicine (COL) cream versus 5% 5-fluorouracil (5-FU) cream for cutaneous field cancerization (CFC). Forty-five patients (90 forearms) with 3–10 actinic keratoses (AK) per forearm applied COL twice daily for 7 days on one forearm and 5-FU twice daily for 21 days on the other. Adverse effects were assessed at 14 days and outcomes at 90 days. Complete AK clearance occurred in 37% with 5-FU vs 17% with COL; partial clearance in 85% vs 78%, with no clear superiority in AK count reduction. Both treatments improved Forearm Photoaging Scale and AK Severity Score, with 5-FU favored for AKSS.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages8

Reading Time20 min

AccessFree to download

Introduction

Methods

Study design and participants

Outcomes and adverse effects

Results

Clearance of actinic keratoses

AK count reduction and clinical scores

Adverse effects

Conclusions

ORIGINAL ARTICLE Efﬁcacy and safety of 0.5% colchicine cream versus 5% 5-ﬂuorouracil cream in the treatment of cutaneous ﬁeld cancerization: a randomized clinical trial􀀂 Amanda Soares Teixeira a,∗ , Ivanka Miranda de Castro Martins b, Anna Carolina Miola b, Hélio Amante Miot b a Department of Dermatology, Instituto Lauro de Souza Lima, Bauru, SP, Brazil b Department of Infectology, Dermatology, Radiotherapy and Diagnostic Imaging, Faculty of Medicine, Universidade Estadual Paulista, Botucatu, SP, Brazil Received 3 August 2023; accepted 2 September 2023 Available online 12 April 2024 KEYWORDS Colchicine; Fluorouracil; Keratosis, actinic; Randomized controlled trials as a topic; Skin neoplasms Abstract Background: 5-Fluorouracil (5-FU) is a ﬁrst-line drug to treat cutaneous ﬁeld cancerization (CFC) . There are few clinical trials with topical colchicine (COL) . Objective: To evaluate the effectiveness of 0.5% COL cream versus 5% 5-FU cream in the treatment of CFC. Method: This was a randomized, open, self-controlled clinical trial. Forty-ﬁve patients (90 forearms), with three to ten actinic keratoses (AK) on each forearm, used 0.5% COL cream 2 × /day for seven days on one forearm, and 5% 5-FU cream 2 × /day, for 21 days, on the other forearm. The dosages were deﬁned based on previous clinical trials for each drug. Adverse effects were evaluated after 14 days and outcomes after 90 days of inclusion. The primary outcome was complete AK clearance and the secondary outcomes were: partial clearance (≥50%), reduction in AK count, assessment of the Forearm Photoaging Scale (FPS), AK Severity Score (AKSS), and adverse effects. Results: After 90 days, there was complete clearance of AK in 37%(95% CI 24%---49%) and partial clearance in 85%(95% CI 76%---93%) of the forearms treated with 5-FU,versus 17%(95% CI 7%---27%) and 78%(95% CI 66%---88%) for COL (p > 0.07) . There was a percentage reduction of 75% in the AK count of the forearms treated with 5-FU (95% CI 66%---83%) and 64% in those treated with COL (95% CI 55%---72%) . Regarding FPS and AKSS, there was improvement in both groups, with no difference regarding FPS (p = 0.654), and 5-FU superiority for AKSS (p = 0.012) . Study limitations: Single-center study. 􀀂 Study conducted at the Department of Dermatology, Instituto Lauro de Souza Lima, Bauru, SP, Brazil. ∗ Corresponding author. E-mails: [dermatologia@ilsl.br](dermatologia@ilsl.br) (A.S. Teixeira), [anna.c.miola@unesp.br](anna.c.miola@unesp.br) (A.C. Miola). [https://doi.org/10.1016/j.abd.2023.09.005](https://doi.org/10.1016/j.abd.2023.09.005) 0365-0596/© 2024 Sociedade Brasileira de Dermatologia. Published by Elsevier Espaa, S.L.U. This is an open access article under the CC BY license ([http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/)). Conclusions: 5-FU and COL are effective for treating CFC, with neither showing superiority regarding the reduction in AK counts. © 2024 Sociedade Brasileira de Dermatologia. Published by Elsevier Espaa, S.L.U. This is an open access article under the CC BY license ([http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/) ). Introduction Actinic keratoses (AK) are atypical proliferations of keratinocytes induced by radiation, especially ultraviolet radiation, resulting from chronic sun exposure.1 Classically, they are considered pre-malignant lesions, with a potential for progression to squamous cell carcinoma (SCC) of up to 0.075% per year for an individual lesion.2 Beyond the analysis of individual lesions, patients with multiple AK have a much higher cumulative incidence of SCC than patients without AK.3 Cutaneous ﬁeld cancerization (CFC) is characterized by multiple AK and/or SCC in situ, occurring in an area chronically exposed to ultraviolet radiation.4 AK and CFC treatment aims to improve patient quality of life, eradicate lesions, prevent the emergence of cutaneo

FAQs

What was the primary goal of comparing 0.5% colchicine and 5% 5-fluorouracil for CFC?

To evaluate effectiveness in treating cutaneous field cancerization, focusing on AK clearance and related clinical outcomes.

How was the randomized self-controlled clinical trial conducted?

Forty-five patients used 0.5% colchicine cream on one forearm for 7 days and 5% 5-fluorouracil on the other forearm for 21 days, with twice-daily applications; adverse effects were checked at 14 days and outcomes at 90 days.

Did either treatment show superiority in reducing AK counts?

No clear superiority was found regarding AK count reduction; both improved outcomes, while 5-FU showed advantage for AK Severity Score.

Sep 21, 2026

Uploaded by Maeve