Preliminary Evidence of Efficacy, Safety, and Treatment Satisfaction with Tirbanibulin 1% Ointment: A Clinical Perspective on Actinic Keratoses

Abstract

Background: Actinic keratosis is a common precancerous skin lesion that can progress into invasive squamous cell carcinomas. Many topical treatments for actinic keratoses often have poor tolerability and prolonged duration. Tirbanibulin is a novel synthetic drug with potent antitumor and antiproliferative activities. Methods: We conducted a single-center, prospective and observational study using tirbanibulin ointment on a 25 cm2 area for 5 consecutive days on 30 participants with AKs on the face or scalp. They were followed for at least 57 days to assess the safety profile and efficacy of the drug as well as treatment satisfaction. We evaluated six signs of local skin reaction (LSR): erythema, scaling, crusting, swelling, blisters/pustules, and erosions/ulcerations, grading the severity as mild, moderate, or severe. The effectiveness was evaluated both clinically and dermoscopically. The treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4). Results: On day 57, 70% of the patients showed a complete clinical and dermoscopic response. The highest scores obtained from the TSQM 1.4 were more evident in the convenience and side effects domains. Most LSRs, including erythema (83.3%), scaling (30%), and swelling (3.3%), occurred on day 8 but resolved spontaneously. Conclusion: Tirbanibulin is a viable therapeutic option with a short regimen treatment and good tolerability, which favors therapy adherence.

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

“…A higher partial response rate was also observed at the eight-week follow-up in the grade 1 group compared to the grade 3 group (78% vs. 55%; p = 0.02), thus suggesting that tirbanibulin performs better on thin lesions, as expected. To date, poor real-life data are available, with heterogeneity in the methods of efficacy evaluation and heterogeneity in the results, making them difficult to compare [14][15][16]. However, the data on tiranibulin's safety profile agrees, with excellent tolerability reported [14][15][16].…”

“…To date, poor real-life data are available, with heterogeneity in the methods of efficacy evaluation and heterogeneity in the results, making them difficult to compare [14][15][16]. However, the data on tiranibulin's safety profile agrees, with excellent tolerability reported [14][15][16]. In fact, compared to other topical treatments already on the market for AKs, tirbanibulin is showing many advantages in terms of safety and patient adherence [17].…”

Digitally Enhanced Methods for the Diagnosis and Monitoring of Treatment Responses in Actinic Keratoses: A New Avenue in Personalized Skin Care

“…This characteristic contributes to its high tolerability and safety profile. Campione et al conducted a study demonstrating that a five-day regimen of daily tirbanibulin application resulted in a complete clinical and dermoscopic response in 70% of the participants by day 57 [52].…”

Anti-aging Effects of Tirbanibulin 1% Ointment: A Real-Life Experience

“…However, although these effects are documented for some AK therapies, they have not yet been explored with the topical application of tirbanibulin 1% ointment. While data about its efficacy and safety profile are already available [11][12][13][14], its impact on photodamage, usually associated with AKs in the context of field cancerization, has recently been reported only in a recent case report [15]. On this topic, we report a retrospective case series of patients affected by AKs on the face and scalp treated with tirbanibulin 1% in which the topical treatment caused a striking amelioration of concomitant photodamage, with improvement of both wrinkles and solar lentigo.…”