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A Randomized, Double Blind, Vehicle-controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT)

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Trial Profile

A Randomized, Double Blind, Vehicle-controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT)

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

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Aminolevulinic acid (Primary)
  • Indications Basal cell cancer; Carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ALA-BCC-CT013
  • Sponsors Biofrontera AG; Biofrontera Bioscience GmbH

Most Recent Events

  • 08 Jan 2025 According to a Biofrontera media release, company announced that Data from follow-up will be included in FDA submission, expected in Q3 2025 and potentially expanding label to the treatment of a cutaneous malignancy
  • 08 Jan 2025 According to a Biofrontera media release, company announced that the last patient has completed the 1 year follow-up visit in December of 2024
  • 31 Oct 2024 According to a Biofrontera media release, Primary endpoint (Composite clinical and histological response of the subjects Main Target Lesion as assessed 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion.) has been met.

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