Biofrontera Inc. announced that the first patient has been dosed in a Phase 3 randomized, double-blind, vehicle-controlled, multicenter clinical study to evaluate the safety and efficacy of Ameluz® and BF-RhodoLED® XL in the field-directed treatment of actinic keratosis (AK) on the extremities, neck and trunk. This Phase 3 clinical study is being conducted by Biofrontera Bioscience GmbH, a wholly owned subsidiary of Biofrontera AG. Initially 11 clinical trial sites in the U.S. will participate, enrolling approximately 165 patients stratified by body region.

This study utilizes Biofrontera's new RhodoLEDXL, a red-light lamp approved by the U.S. Food and Drug Administration (FDA) for use in PDT in combination with Ameluz® (Ameluz- PDT) for the treatment of mild-to-moderate actinic keratosis.