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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: 01 Jan 2026

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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

  • 18 Dec 2025 According to a Biofrontera media release, company announced the completion of the transfer of FDA approvals for Ameluz and the RhodoLED Lamp Series, including the NDA, to Biofrontera, enabling the company to independently manage ongoing and future clinical development and take full responsibility for manufacturing and marketing in the U.S.
  • 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.

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