Comparative Efficacy and Tolerability of Imiquimod 3.75% Cream vs 5-Fluorouracil 4% cream in the Treatment of Actinic Keratosis: A Split-Face Study

Introduction: Actinic keratosis (AK) is a common precancerous skin lesion that arises on chronically UV-exposed skin and can progress to keratinocyte carcinoma. Objective: The aim of this study is to compare efficacy, safety, local skin reaction, time to wound closure, and patient preference of imi...

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Main Authors: Cesare Ariasi, Carola Romanò, Cesare Tomasi, Gaetano Licata, Davide Geat, Piergiacomo Calzavara-Pinton, Mariachiara Arisi
Format: Article
Language:English
Published: Mattioli1885 2025-01-01
Series:Dermatology Practical & Conceptual
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Online Access:https://dpcj.org/index.php/dpc/article/view/4583
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author Cesare Ariasi
Carola Romanò
Cesare Tomasi
Gaetano Licata
Davide Geat
Piergiacomo Calzavara-Pinton
Mariachiara Arisi
author_facet Cesare Ariasi
Carola Romanò
Cesare Tomasi
Gaetano Licata
Davide Geat
Piergiacomo Calzavara-Pinton
Mariachiara Arisi
author_sort Cesare Ariasi
collection DOAJ
description Introduction: Actinic keratosis (AK) is a common precancerous skin lesion that arises on chronically UV-exposed skin and can progress to keratinocyte carcinoma. Objective: The aim of this study is to compare efficacy, safety, local skin reaction, time to wound closure, and patient preference of imiquimod (IMQ) 3.75% vs 5-fluorouracil (5-FU) 4% cream treatment for AKs. Methods: Two symmetrical contralateral areas of approximately 25 cm2 harboring a similar (≥5) number of AKs were selected and randomly assigned to IMQ 3.75% or 5- FU 4% cream treatment. The total number of AKs for each patient, was evaluated at baseline (T0) and 90 days after the end of treatments (T1). Local skin reaction (LSR) score was registered the day after the end of both treatments. Complete remission rate of lesions, cosmetic outcome, and patient preference of treatment were assessed after 90 days (T1). Results: The mean variation (ΔT0-T1) of AKs was not significantly different in patients treated with IMQ 3.75% and 5-FU 4% (p=0.35). The mean LSR was not significantly different for patients treated with IMQ 3.75% and 5-FU 4% (p=0.63). No difference in cosmetic outcome was observed in the 2 groups. Patient preference was equally distributed between the treatments. The mean time to wound closure after the end of the treatment was similar after IMQ 3.75% as compared to 5-FU 4% (p=0.83). Conclusions: This study reports a non-superiority of efficacy, tolerability, wound-healing time, and cosmetic outcome of topical IMQ 3.75% treatment compared to topical 5-FU 4% treatment in AK management.
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spelling doaj-art-56bd48503aa5411e90e9a8f2d71387f42025-02-04T15:41:41ZengMattioli1885Dermatology Practical & Conceptual2160-93812025-01-0115110.5826/dpc.1501a4583Comparative Efficacy and Tolerability of Imiquimod 3.75% Cream vs 5-Fluorouracil 4% cream in the Treatment of Actinic Keratosis: A Split-Face StudyCesare Ariasi0Carola Romanò1Cesare Tomasi2Gaetano Licata3Davide Geat4Piergiacomo Calzavara-Pinton5Mariachiara Arisi6 Department of Dermatology, University of Brescia, Brescia, ItalySpedali civili- U.O. Dermatology- Brescia Department of Dermatology, University of Brescia, Brescia, ItalyDermatology Unit, San Antonio Abate Hospital, Trapani, Italy Department of Dermatology, University of Brescia, Brescia, Italy Department of Dermatology, University of Brescia, Brescia, Italy Department of Dermatology, University of Brescia, Brescia, Italy Introduction: Actinic keratosis (AK) is a common precancerous skin lesion that arises on chronically UV-exposed skin and can progress to keratinocyte carcinoma. Objective: The aim of this study is to compare efficacy, safety, local skin reaction, time to wound closure, and patient preference of imiquimod (IMQ) 3.75% vs 5-fluorouracil (5-FU) 4% cream treatment for AKs. Methods: Two symmetrical contralateral areas of approximately 25 cm2 harboring a similar (≥5) number of AKs were selected and randomly assigned to IMQ 3.75% or 5- FU 4% cream treatment. The total number of AKs for each patient, was evaluated at baseline (T0) and 90 days after the end of treatments (T1). Local skin reaction (LSR) score was registered the day after the end of both treatments. Complete remission rate of lesions, cosmetic outcome, and patient preference of treatment were assessed after 90 days (T1). Results: The mean variation (ΔT0-T1) of AKs was not significantly different in patients treated with IMQ 3.75% and 5-FU 4% (p=0.35). The mean LSR was not significantly different for patients treated with IMQ 3.75% and 5-FU 4% (p=0.63). No difference in cosmetic outcome was observed in the 2 groups. Patient preference was equally distributed between the treatments. The mean time to wound closure after the end of the treatment was similar after IMQ 3.75% as compared to 5-FU 4% (p=0.83). Conclusions: This study reports a non-superiority of efficacy, tolerability, wound-healing time, and cosmetic outcome of topical IMQ 3.75% treatment compared to topical 5-FU 4% treatment in AK management. https://dpcj.org/index.php/dpc/article/view/4583actinic keratosissplit-face studytopical 5-fluorouraciltopical Imiquimod
spellingShingle Cesare Ariasi
Carola Romanò
Cesare Tomasi
Gaetano Licata
Davide Geat
Piergiacomo Calzavara-Pinton
Mariachiara Arisi
Comparative Efficacy and Tolerability of Imiquimod 3.75% Cream vs 5-Fluorouracil 4% cream in the Treatment of Actinic Keratosis: A Split-Face Study
Dermatology Practical & Conceptual
actinic keratosis
split-face study
topical 5-fluorouracil
topical Imiquimod
title Comparative Efficacy and Tolerability of Imiquimod 3.75% Cream vs 5-Fluorouracil 4% cream in the Treatment of Actinic Keratosis: A Split-Face Study
title_full Comparative Efficacy and Tolerability of Imiquimod 3.75% Cream vs 5-Fluorouracil 4% cream in the Treatment of Actinic Keratosis: A Split-Face Study
title_fullStr Comparative Efficacy and Tolerability of Imiquimod 3.75% Cream vs 5-Fluorouracil 4% cream in the Treatment of Actinic Keratosis: A Split-Face Study
title_full_unstemmed Comparative Efficacy and Tolerability of Imiquimod 3.75% Cream vs 5-Fluorouracil 4% cream in the Treatment of Actinic Keratosis: A Split-Face Study
title_short Comparative Efficacy and Tolerability of Imiquimod 3.75% Cream vs 5-Fluorouracil 4% cream in the Treatment of Actinic Keratosis: A Split-Face Study
title_sort comparative efficacy and tolerability of imiquimod 3 75 cream vs 5 fluorouracil 4 cream in the treatment of actinic keratosis a split face study
topic actinic keratosis
split-face study
topical 5-fluorouracil
topical Imiquimod
url https://dpcj.org/index.php/dpc/article/view/4583
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