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A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients With Actinic Keratosis on the Face or Scalp

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A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients With Actinic Keratosis on the Face or Scalp

Status: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 13 Feb 2025

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At a glance

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

    • Most Recent Events

    • 07 Feb 2025 Planned End Date changed from 1 Mar 2027 to 1 Jun 2027.
    • 07 Feb 2025 Planned primary completion date changed from 1 Mar 2027 to 1 Jun 2027.
    • 07 Feb 2025 Status changed from recruiting to active, no longer recruiting.

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