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A Randomized, Double Blind, Vehicle-controlled, Multicenter Phase II Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz) and BF-RhodoLED in the Treatment of Moderate to Severe Acne Vulgaris in Adults With Photodynamic Therapy (PDT)

Trial Profile

A Randomized, Double Blind, Vehicle-controlled, Multicenter Phase II Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz) and BF-RhodoLED in the Treatment of Moderate to Severe Acne Vulgaris in Adults With Photodynamic Therapy (PDT)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Jan 2026

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At a glance

  • Drugs Aminolevulinic acid (Primary)
  • Indications Acne vulgaris
  • Focus Therapeutic Use
  • Sponsors Biofrontera Bioscience GmbH

Most Recent Events

  • 09 Jan 2026 According to Biofrontera media release, results are expected to be presented to the FDA in early Q3 2026 and are intended to provide the basis of a future Phase 3 program
  • 09 Jan 2026 According to Biofrontera media release, company announced the successful database lock of the study on January 5, 2026. All data from participants that is collected throughout study is captured in a specific database. Data for to be available in February of this year.
  • 22 Dec 2025 Planned End Date changed from 1 Nov 2025 to 1 Jan 2026.

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