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A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BF-200 ALA (Ameluz) in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp With Photodynamic Therapy (PDT)

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Trial Profile

A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BF-200 ALA (Ameluz) in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp With Photodynamic Therapy (PDT)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Oct 2024

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At a glance

  • Drugs Aminolevulinic acid (Primary)
  • Indications Actinic keratosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Biofrontera Bioscience GmbH

    • Most Recent Events

    • 07 Oct 2024 According to a Biofrontera media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the Companys sNDA to increase the maximally approved dosage from one to three tubes of Ameluz per treatment. The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz were applied to 116 patients.
    • 03 May 2023 Status changed from recruiting to completed.
    • 12 Jan 2023 Planned End Date changed from 1 Dec 2022 to 1 Mar 2023.

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