NCT06135415

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

A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 centimeter square (cm\^2) and up to 100 cm\^2 in adult participants with actinic keratosis (AK).

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DRUG	Tirbanibulin	Participants will apply tirbanibulin ointment topically on the face or balding scalp with AK.
OTHER	Vehicle ointment	Participants will apply vehicle ointment topically on the face or balding scalp with AK.

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-04-30
• Completion: 2025-11-25
• First posted: 2023-11-18
• Last updated: 2026-03-25

Locations

35 sites across 5 countries: Germany, Italy, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study