Tirbanibulin Ointment found to be Effective for treatment of
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The tubulin polymerization and Src kinase signaling inhibitor tirbanibulin is being investigated as a topical treatment for actinic keratosis, a precursor of squamous-cell carcinoma.

In two identically designed double-blind trials, researchers randomly assigned, in a 1:1 ratio, adults with actinic keratoses on the face or scalp to receive either topical tirbanibulin or vehicle (placebo) ointment. The ointment was applied by the patients to a 25-cm2 contiguous area containing four to eight lesions once daily for 5 consecutive days.

The primary outcome was the percentage of patients with a complete (100%) reduction in the number of lesions in the application area at day 57. The secondary outcome was the percentage of patients with a partial (more than 75%) reduction in the number of lesions within the application area at day 57. The incidence of recurrence was evaluated at 1 year. Local reactions were scored with the use of 4-point scale (ranging from 0 [absent] to 3 [severe]). A total of 702 patients were enrolled in the two trials (351 patients per trial).

Results:
--Complete clearance in trial 1 occurred in 44% of the patients in the tirbanibulin group and in 5% of those in the vehicle group (difference, 40 percentage points); in trial 2, the percentages were 54% and 13%, respectively.

--The percentages of patients with partial clearance were significantly higher in the tirbanibulin groups than in the vehicle groups.

--At 1 year, the estimated percentage of patients with recurrent lesions was 47% among patients who had had a complete response to tirbanibulin.

--The most common local reactions to tirbanibulin were erythema in 91% of the patients and flaking or scaling in 82%.

--Adverse events with tirbanibulin were application-site pain in 10% of the patients and pruritus in 9%, all of which resolved.

Conclusively, in two identically designed trials, tirbanibulin 1% ointment administered once daily for 5 days was superior to the actinic keratosis treatment vehicle at 2 months but was correlated with transient local reactions and 1-year lesion recurrence.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2024040?query=featured_home
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