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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: 19 Feb 2026

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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

  • 11 Feb 2026 According to a Biofrontera media release, company announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted filing of the Companys supplemental New Drug Application (sNDA) for Ameluz topical gel used in combination with the RhodoLED red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026.
  • 02 Dec 2025 According to a Biofrontera media release, company announced the submission of an sNDA to the FDA, seeking approval of Ameluz-PDT for the treatment of sBCC.
  • 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

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