Spotlighting Data on Clearance of Actinic Keratosis Using Tirbanibulin, With Neal Bhatia, MD

Rates of actinic keratosis (AK) clearance and lesion count reductions attained using tirbanibulin therapy in randomized control trials (RCTs) approximated findings attained in an open-label phase 4 study and in real-world clinical settings, recent data suggest.1,2

These data, highlighted in a poster titled ‘Clearance of actinic keratosis with tirbanibulin: Comparing results from controlled trials with real-world/low interventional clinical studies,’ were presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. Presenter Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research and chief medical editor for Practical Dermatology, spoke with HCPLive about these data on tirbanibulin and their significance.

“For me, I like to use what's called the ‘windshield wiper,’ where you treat, basically the temples over the forehead and back to the other temple, [and this], for men, is the hotspot is both temples and cheeks,” Bhatia said. “You can also get a little bit of the nose and the ears covered, which is really nice. The bottom line though is that the local skin reactions are very mild. This is not working on inflammation or creating necrosis, like we see with [5-fluorouracil]...This is working on phagocytosis and apoptosis, which is basically programmed cell death, and being enhanced and taking the atypical keratinocytes that make an actinic keratosis and basically watching them implode.”

Bhatia was asked about additional elements covered in his presentation of these data on tirbanibulin. He highlighted

“There has been a phobia among dermatologists for patients just don't want to get red,” Bhatia said. “...You don't have that. You don't really have a need for really taking down time [with this drug]. I tell patients that the peak reaction is going to be about Day 8, because that's what we learned in the trials. If you can get a timeline, saying to do the 5 in a row, maybe between Day 8 and Day 20, don't schedule any photo shoots or go to any weddings. By Day 29, everything should be back to zero. I think that's a good way to describe it to patients.”

Bhatia highlighted this as a way to describe treatment to patients with actinic keratosis. Dermatologists, Bhatia explained, should use the drug in combination with what is typically utilized in the office.

“For me, this is really a no brainer, to think about why topicals make sense,” Bhatia said. “More importantly is knowing that we don't have very aggressive and limiting local skin reactions. I think that's real important. I always tell dermatologists, ‘Don't call these side effects.’ These are expected or anticipated local skin reactions based on the mechanism, and if you can just mitigate those with it with a mechanism that does the job and patients will stick with it.”

To find out more information related to data presented at EADV, view our latest coverage of the conference.

Bhatia has reported serving as a consulting honoraria from and investigator for Almirall, Biofrontera, Leo, Ortho, and Sun Pharma.

References

1. Bhatia N, Martin G, Schlesinger T, et al. Clearance of actinic keratosis with tirbanibulin: Comparing results from controlled trials with real-world/low interventional clinical studies. Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

2. Bhatia N, Lain E, Blauvelt A, et al. Safety and tolerability of tirbanibulin ointment 1% treatment on 100 cm2 of the face or scalp in patients with actinic keratosis: A phase 3 study. JAAD Int. 2024 Jul 18;17:6-14. doi: 10.1016/j.jdin.2024.07.001. PMID: 39268198; PMCID: PMC11387381.