Trial Profile

A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED XL or BF-RhodoLED Lamp

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 14 Jul 2025

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At a glance

03 Jul 2025 Planned End Date changed from 1 May 2026 to 1 Jun 2026.
03 Jul 2025 Planned primary completion date changed from 1 Aug 2025 to 1 Sep 2025.
18 Mar 2025 According to a Biofrontera Inc media release, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the second half of 2026.

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