In this episode of Topical Conversations, Neal Bhatia, MD, and Naiem Issa, MD, discuss the use of tirbanibulin (Klisyri) for actinic keratosis (AK), including its expanded indication for broader application areas. The FDA’s expanded approval in June 2024 allows tirbanibulin to be used over surface areas up to 100 cm², offering dermatologists a more versatile approach to treating larger areas on the face or scalp. 

FDA approval for larger surface area treatment 

Initially approved in 2020 for application on small areas up to 25 cm², tirbanibulin's expanded indication provides flexibility for dermatologists managing AK. With 2 packaging sizes—a 250-mg dose for up to 25 cm² and a new 350-mg package for up to 100 cm²—clinicians can select the appropriate dose to treat larger surface areas effectively. 

A practical application technique: the “windshield wiper” approach 

To maximize coverage and effectiveness, Dr Bhatia recommends a straightforward method he calls the “windshield wiper” approach, instructing patients to apply tirbanibulin from temple to temple, across the forehead, and including the nose and ears. This application technique ensures comprehensive treatment over larger areas, essential for patients with diffuse AK. 

Mechanism of action: apoptosis vs necrosis 

One of the unique aspects of tirbanibulin is its apoptotic mechanism, which selectively induces cell death in abnormal cells, sparing surrounding healthy tissue. Unlike traditional AK treatments that cause necrosis and associated discomfort, tirbanibulin’s pathway results in fewer inflammatory skin reactions. This distinction makes it an attractive option for dermatologists looking to offer a gentler but effective alternative to patients with AK, who often experience visible irritation with standard therapies. 

A sequential approach to AK treatment 

Dr Bhatia shared his protocol for AK management, combining multiple therapeutic approaches to target both visible lesions and subclinical precursors. His approach involves initially using cryotherapy to address active lesions, followed by a course of tirbanibulin after one to 2 weeks, and potentially incorporating photodynamic therapy (PDT) within a few months. This holistic strategy can help provide comprehensive control over AK, addressing both current lesions and preexisting, yet undetectable, cells. 

For dermatologists without access to PDT, Dr Issa recommends a segmented approach. He suggests starting with one facial area (eg, temple-to-temple) and then evaluating results after 3 to 4 months. Patients can then treat additional sections over time, minimizing the burden of treating an entire facial area at once. 

Patient counseling and setting realistic expectations 

Setting expectations is crucial for successful tirbanibulin treatment. Dr Bhatia encourages dermatologists to advise patients that tirbanibulin’s effects are generally noticeable around days 8 to 15. To help patients understand the process, he likens the experience to a slightly turbulent flight that ultimately results in a smooth landing. 

Patients often appreciate tirbanibulin’s 5-day treatment protocol, especially when compared to longer regimens required by other AK treatments such as diclofenac or imiquimod. This shorter treatment period increases adherence and may reduce the need for frequent follow-up appointments. 

Ongoing maintenance: encouraging long-term care for AK 

Both Dr Issa and Dr Bhatia emphasized the importance of educating patients on the need for periodic AK maintenance. Dr Issa noted that encouraging patients to treat one facial area, then reassessing after several months, fosters a consistent approach to ongoing AK care. 

Key benefits of tirbanibulin for dermatologists and patients 

With its unique apoptotic mechanism, flexible dosing options, and shorter treatment duration, tirbanibulin has emerged as a valuable addition to the AK treatment landscape. Dr Bhatia concluded that tirbanibulin’s mild side effect profile, relative safety, and potential for high patient satisfaction make it an underutilized tool with promise for dermatologists. He encouraged documenting patient experiences to support reimbursement, which could enhance accessibility and adherence to tirbanibulin as part of an ongoing AK management plan.