Tirbanibulin 1% Ointment for Actinic Keratosis - Results from a Real-Life Study

Sep 21, 2026

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Tirbanibulin 1% ointment is described as a novel synthetic anti-proliferative agent that inhibits tubulin polymerization and is approved for actinic keratosis (AK) on the face and scalp in adults. Phase 3 trials showed strong efficacy, safety, and adherence, but real-world evidence is limited. A spontaneous, open-label prospective study at the University Hospital of Messina evaluated effectiveness and safety in 38 consecutive patients.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages12

Reading Time30 min

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Abstract

1. Introduction

2. Materials and Methods

2.1. Inclusion and Exclusion Crite

medicina Article Tirbanibulin 1% Ointment for Actinic Keratosis: Results from a Real-Life Study Federica Li Pomi 1, Mario Vaccaro 1, Giovanni Pallio 2, Michelangelo Rottura 3, Natasha Irrera 3 and Francesco Borgia 1, * Citation: Li Pomi, F.; Vaccaro, M.; Pallio, G.; Rottura, M.; Irrera, N.; Borgia, F. Tirbanibulin 1% Ointment for Actinic Keratosis: Results from a Real-Life Study. Medicina 2024, 60, 225 . [https://doi.org/10.3390/](https://doi.org/10.3390/)[ ](https://doi.org/10.3390/)medicina60020225 Academic Editor: Adam Reich Received: 3 December 2023 Revised: 20 January 2024 Accepted: 26 January 2024 Published: 28 January 2024 Copyright: © 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ([https://](https://)[ ](https://)[creativecommons.org/licenses/by/](creativecommons.org/licenses/by/)[ ](creativecommons.org/licenses/by/)[4.0/](4.0/)) . 1 Department of Clinical and Experimental Medicine, Section of Dermatology, University of Messina, 98125 Messina, Italy; [federicalipomi@hotmail.it](federicalipomi@hotmail.it) (F.L.P.); [mario.vaccaro@unime.it](mario.vaccaro@unime.it) (M.V.) 2 Department of Biomedical and Dental Sciences and Morphological and Functional Imaging, University of Messina, 98125 Messina, Italy; [giovanni.pallio@unime.it](giovanni.pallio@unime.it) 3 Department of Clinical and Experimental Medicine, Section of Pharmacology, University of Messina, 98125 Messina, Italy; [michelangelo.rottura@unime.it](michelangelo.rottura@unime.it) (M.R.); [natasha.irrera@unime.it](natasha.irrera@unime.it) (N.I.) * Correspondence: [fborgia@unime.it](fborgia@unime.it) Abstract: Background and Objectives: Tirbanibulin 1% ointment is a novel synthetic anti-proliferative agent that inhibits tubulin polymerization. It is approved for treating actinic keratosis (AK) on the face and scalp in adults. It has demonstrated good efficacy, an adequate safety profile and excellent patient adherence in the phase 3 clinical trials, however data about its real-life efficacy and safety are lacking. Here we report the experience of the dermatology unit of the University Hospital of Messina. Materials and Methods: We performed a spontaneous open-label, prospective non-randomized study to assess the effectiveness and safety of tirbanibulin 1% ointment for the treatment of 228 AKs in 38 consecutive patients—28 males (73%) and 10 females (26%)—aged between 52 and 92 years (mean age: 72 ± 8.92 years) . Results: Total clearance was recorded in 51% of lesions, while partial clearance was recorded in 73% of lesions. An excellent tolerability profile and high compliance rate were observed, with no treatment discontinuation due to the onset of adverse events. Conclusion: Our real-life experience confirms the effectiveness and safety of tirbanibulin ointment for the treatment of AKs. Keywords: tirbanibulin; tirbanibulin ointment; actinic keratosis; real-life 1. Introduction Actinic keratosis (AK) is a neoplasm of intraepithelial keratinocytes commonly found in sun-exposed areas in adults, especially the face, scalp and dorsal hands [1] . Risk factors include older age, male gender, Fitzpatrick skin types I–II, chronic ultraviolet (UV) radiation exposure, sunbed use, prolonged immunosuppression and prior history of AKs and nonmelanoma skin cancer (NMSK) [2,3] . Olsen’s clinical grading categorizes AK lesions as grade 1 (faint pink macules that are barely visible but easily felt), grade 2 (moderately thick, red and scaly lesions that are easily felt and seen) and grade 3 (very thick, hyperkeratotic lesions that are sometimes challenging to differentiate from early cutaneous squamous cell carcinomas [cSCCs]) [4] . However, recent studies highlight discrepancies between clinical and histological grading, with Olsen grading lower than the histological grade in 62.4% of cases [5] . It has b

FAQs

What is tirbanibulin 1% ointment intended to treat?

It is intended for treating actinic keratosis (AK) on the face and scalp in adults.

How was the real-life study designed and who participated?

The study was a spontaneous open-label, prospective non-randomized evaluation including 38 consecutive patients with a total of 228 AK lesions.

What effectiveness and tolerability outcomes were reported?

Total clearance was recorded in 51% of lesions and partial clearance in 73%. An excellent tolerability profile and high compliance were reported, with no treatment discontinuation due to adverse events.

Sep 21, 2026

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