A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) in comparison to Metvix in the treatment of non-aggressive basal cell carcinoma (BCC) with photodynamic therapy (PDT)

Trial Profile

A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) in comparison to Metvix in the treatment of non-aggressive basal cell carcinoma (BCC) with photodynamic therapy (PDT)

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Aminolevulinic acid (Primary) ; Methyl aminolevulinate
  • Indications Basal cell cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Biofrontera Bioscience GmbH
  • Most Recent Events

    • 15 Apr 2016 Status changed from active, no longer recruiting to completed, as reported in a Biofrontera AG media release.
    • 04 Mar 2016 According to a Biofrontera AG media release, European approval of BF200 ALA for the treatment of basal-cell cancer expected in the fourth quarter of 2016.
    • 04 Mar 2016 Full results published in a Biofrontera media release.
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