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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

Trial Profile

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 of Trial: Phase III

Latest Information Update: 06 Nov 2025

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At a glance

  • Drugs Tirbanibulin (Primary)
  • Indications Actinic keratosis
  • Focus Therapeutic Use
  • Sponsors Almirall S.A.

Most Recent Events

  • 17 Sep 2025 Primary endpoint (Percent Change From Baseline in Lesion Count at Day 57) has been met.
  • 17 Sep 2025 Results presented in the Almirall, S.A. Media Release.
  • 17 Sep 2025 According to an Almirall, S.A. media release, data from this study will be presented at the 34th European Academy of Dermatology and Venereology Congress (EADV) taking place from September 17 to 20 in Paris, France.

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