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
Neal Bhatia, Edward Lain, Abel Jarell, Janet DuBois, María Luisa Tamarit, Meritxell Falqués, Vera Kiyasova, Laura Padullés, Raquel Otero, Andrew Blauvelt
Abstract
Background Tirbanibulin is approved for actinic keratosis (AK) field treatment up to 25 cm 2 . However, AK often affects larger areas; thus, AK treatments for larger fields are needed. Objective Evaluate the safety and tolerability of tirbanibulin when applied to a field of approximately 100 cm 2 . Methods Phase 3, multicenter, open-label, single-arm study among adult patients having a treatment field on the face or balding scalp of approximately 100 cm 2 with 4-12 AKs. Patients received tirbanibulin to cover the treatment field once daily (5 consecutive days). Safety was assessed by evaluating treatment emergent adverse events and tolerability by composite score of 6 local tolerability signs (LTS). Results A total of 105 patients were included. The most common LTS were erythema (96.1%) and flaking/scaling (84.4%), being mostly mild-to-moderate severity, and resolved/returned to or close to baseline by Day 29. The only severe LTS were erythema (5.8%) and flaking/scaling (8.7%). Most frequent treatment emergent adverse events were application site pruritus (10.5%) and application site pain (8.6%). Mean total number of AKs decreased from 7.7 AKs at baseline to 1.8 AKs at Day 57. Mean percent of change (reduction) from baseline in lesion count was 77.8% at Day 57. Limitations No control group. No long-term follow-up. Conclusion Safety and tolerability profiles in patients treated with tirbanibulin up to 100 cm 2 were consistent with those previously reported over smaller field. Tirbanibulin could be used on a larger field (>25 cm 2 ).