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A randomized, double-blind, phase III multi-center study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using BF-RhodoLED lamp

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Trial Profile

A randomized, double-blind, phase III multi-center study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using BF-RhodoLED lamp

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2023

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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

  • 11 May 2016 According to Biofrontera media release, the the U.S. Food and Drug Administration (FDA) has granted approval of its combination topical prescription drug Ameluz (BF-200 ALA) and medical device BF-RhodoLED for photodynamic therapy (PDT) treatment of mild to moderate actinic keratosis (AK) on the face and scalp.
  • 04 Apr 2016 According to Biofrontera media release, company has announced an update on the latest progress of its New Drug Application (NDA). The FDA has issued the proposed labeling for BF-200 ALA, the Company's prescription drug for the treatment of mild to moderate actinic keratosis (AK) on the face and scalp.
  • 27 Feb 2016 Results published in the British Journal of Dermatology.

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