Klisyri (tirbanibulin ointment)

P4, N=342, Completed, Almirall, S.A. | Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024

P2, N=5, Completed, Austin Institute for Clinical Research | Recruiting --> Completed | N=10 --> 5

Tirbanibulin 1% ointment is a synthetic antiproliferative agent approved in 2021 by the European Union for treating actinic keratoses (AK). These results demonstrate that tirbanibulin may impact expression of HPV oncoproteins via the Src- MEK- pathway. Tirbanibulin significantly downregulates oncogenic proteins related to cell cycle regulation and cell proliferation while upregulating apoptosis pathways.

P4, N=0, Withdrawn, Medical University of Graz | N=30 --> 0 | Not yet recruiting --> Withdrawn

P3, N=270, Recruiting, Almirall, S.A. | Not yet recruiting --> Recruiting

P3, N=108, Completed, PharmaEssentia | Active, not recruiting --> Completed

P4, N=540, Recruiting, Almirall, S.A. | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2026 --> Mar 2027

P4, N=342, Completed, Almirall, S.A. | Recruiting --> Completed

P3, N=270, Not yet recruiting, Almirall, S.A.

P3, N=270, Not yet recruiting, Almirall, S.A.

P4, N=22, Completed, Medical University of Graz | Recruiting --> Completed | Trial completion date: May 2024 --> Nov 2023 | Trial primary completion date: May 2024 --> Nov 2023

There is also a clear correlation between cost and treatment outcomes, considering BCC's ever-growing prevalence and the proportion of excised lesions being reported as malignant. This review will discuss BCC and AK lesion criteria that result in the most successful outcomes using topical treatments, then highlight the various topical treatment options, and finally address their clinical significance moving forward.

Tirbanibulin 1% ointment significantly and rapidly reduced the AKASI score in a real-world setting. The complete clearance rates were in line with those observed in the two pivotal trials.

OBSERVATION: Among available treatments, it is possible to distinguish lesion-directed therapies (cryotherapy, laser therapy, conventional photodynamic theapy and surgery when a progression to iSCC is suspected) and field-directed therapies (5-fluorouracil, diclofenac,piroxicam, imiquimod and daylight photodynamic therapy)associated to daily appropriate photoprotection...We evaluated efficacy, safety and adherence to therapy of topical ointments indicated for the treatment of the different clinico-pathologic variants of AK (focusing on tirbanibulin and 5-Fluorouracil 0.5%, Salicylic Acid 10%), providing a clinical, dermoscopic and OCT longitudinal evaluation...Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis...2021;384(6):512-520. doi:10.1056/NEJMoa2024040

This demonstrates a novel therapy for SCC and SCCIS. Prospective studies of topical tirbanibulin for the treatment of SCC are warranted

OBJECTIVES: To investigate if LC-OCT may be useful in monitoring AKs changes during treatment with tirbanibulin 1% ointment. Although some limitations of our pilot study include the small sample size and the lack of biopsy before and after treatment, it confirms the efficacy and safety of tirbanibulin in treating AKs and the usefulness of LC-OCT for the therapeutic monitoring of skin tumors along with the identification of signs of apoptosis and inflammation resulting from such treatments

P2, N=10, Recruiting, Austin Institute for Clinical Research | Not yet recruiting --> Recruiting

There are reports of successful use of topical imiquimod, photodynamic therapy (PDT) and topical 5-fluorouracil with recurrence when treatment is discontinued...He previously applied topical imiquimod, discontinued due to systemic reaction, ingenol mebutate, 5-fluorouracil, and performed PDT with low benefits...For these reasons, we used tirbanibulin ointment on the area of previous surgery and on the peripheral area (right hemi- frontal), applying it once a day for 2 cycles of 5 days with 14 days of break between the 2 cycles...Tirbanibulin has a selective action against cells that most express microtubules and its action is, ideally, to be considered more effective the greater the number of mitoses. Based on this reasoning, we used tirbanibulin in the treatment of iSCC, not as an alternative to the surgical proposal, which always remains the first-line of therapy, but as an adjuvant approach in a selected patient to reduce the risk of progression, waiting for a possible wide local excision.

Although the etiology remains unknown, its development has been associated with several factors, the most important of which is represented by trauma, sunburns, medical procedures, and topical medications, including those used to treat actinic keratoses such as imiquimod and fluorouracil. Results Tirbanibulin showed low impact on EPDS, causing only a mild worsening of the symptoms easily controlled with a short course of topical steroids while maintaining high efficacy with regard to actinic keratoses and the field of cancerization. Discussion From our experience, topical tirbanibulin is a treatment to be considered in this type of patients, as tirbanibulin induces apoptosis and not necrosis resulting in less release of proinflammatory cytokines and reduced inflammatory stimulation in comparison with other treatments in use for actinic keratoses.