Biofrontera's Phase 3 Ameluz trial for AK on extremities/neck posts results after completion

Biofrontera Inc. had one registry update this period, concerning its late-stage actinic keratosis trial.

• A Phase III study testing BF-200 ALA (Ameluz) combined with red light photodynamic therapy using RhodoLED lamps for actinic keratosis on the extremities and neck/trunk is listed as completed, with primary completion on 2025-09-03 and study completion on 2026-07-01.¹ Results were first posted on 2026-08-21.¹ The trial enrolled 172 participants and compared BF-200 ALA (10% 5-ALA HCl) against vehicle.¹ Its primary outcome was the Overall Subject Complete Response Rate, defined as the percentage of subjects with all actinic keratosis target lesions clinically cleared after the last photodynamic therapy session, measured 12 weeks after the last treatment.¹