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A randomized, double-blind, intra-individual, multi-center phase III study to evaluate the safety and efficacy of BF 200 ALA (Ameluz) versus placebo in the treatment of mild to severe actinic keratosis on extremities, trunk/ neck with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

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Trial Profile

A randomized, double-blind, intra-individual, multi-center phase III study to evaluate the safety and efficacy of BF 200 ALA (Ameluz) versus placebo in the treatment of mild to severe actinic keratosis on extremities, trunk/ neck with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2021

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At a glance

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

    • Most Recent Events

    • 17 Mar 2021 Results assessing efficacy and safety of BF-200 ALA vurses vehicle in the treatment of mild to severe Actinic-keratosis located on extremities/trunk/neck with red light photodynamic therapy (PDT), published in the Journal of the American Academy of Dermatology.
    • 10 Mar 2020 According to a Biofrontera AG media release, on the basis of the results from this study, the European Commission has approved the use of Biofrontera prescription drug Ameluz in combination with photodynamic therapy (PDT) for the treatment of actinic keratosis (AK) on the extremities and trunk/neck. In addition, the results of the follow-up phase of the clinical study comparing daylight PDT with Ameluz and Metvix were included in the product information (SmPC).
    • 03 Feb 2020 According to a Biofrontera AG media release, the results of the follow-up phase of the clinical comparative study for daylight PDT with Ameluz(R) and Metvix(R) will be included in the product information (SmPC). The European Commission will issue formal approval within the coming weeks.
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