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: 15 Dec 2025

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At a glance

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
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

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