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A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp

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Trial Profile

A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jan 2024

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At a glance

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

    • Most Recent Events

    • 01 Jan 2024 Results of post hoc analysis (NCT03285477 ,N = 351 and NCT03285490 N = 351) assessing Efficacy and safety of tirbanibulin 1% ointment in actinic keratoses published in the Journal of the European Academy of Dermatology and Venereology
    • 21 Mar 2023 Results presented at the American Academy of Dermatology annual Meeting 2023
    • 19 Jul 2021 According to an Athenex media release, Almirall has received approval from the European Commission to market Klisyri (tirbanibulin), indicated for the topical treatment of actinic keratosis (AK) of the face or scalp in adults.This approval is based on the positive results from two pivotal Phase III studies (KX01-AK-003 and KX01-AK-004).

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