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A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis

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Trial Profile

A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2024

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At a glance

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

    • Most Recent Events

    • 10 Jun 2024 According to an Almirall S.A. media release, FDA has approved tirbanibulin (Klisyri; Almirall) for use on larger areas of the face or scalp up to 100 cm2 to address actinic keratosis, based on an additional phase 3, multicenter, open-label, clinical safety study with more than 100 participants in the US.
    • 12 Mar 2024 Results assessing whether area size or number of AKs in the treatment field affected tolerability with tirbanibulin treatment , presented at the American Academy of Dermatology annual Meeting 2024
    • 19 Feb 2024 According to an Almirall S.A. media release, based on the data of this study company submitted a supplementary NDA in August 2023 anticipating a launch in the second half of 2024.

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