A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis

Summary

The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 square centimeters (cm\^2) and up to 100 cm\^2 in adult participants with actinic keratosis (AK).

Timeline

Start

2023-12-21

Primary completion

2025-04-30

Completion

2025-11-25

Outcome

Met primary endpoint

registry analysis (superiority test); Vehicle Ointment vs Tirbanibulin 10 mg/g; p <0.001; Least-squares (LS) mean difference -38.92 (95% CI -48.20 to -29.64); ANCOVA NCT06135415 ↗

Drugs

Indications