A study published in the Journal of the American Academy of Dermatology aimed to determine the efficacy and safety of BF-200 ALA versus vehicle in the treatment of mild-to-severe AK located on extremities, trunk and neck with red light photodynamic therapy (PDT).

This was a phase III study with an intra-individual design with 50 patients in 6 centers in Germany. Here, each patient received a maximum of 2 field-directed PDTs; 1-year follow-up results were recorded.

BF-200 ALA was found to be superior to the vehicle with respect to total lesion clearance rates and patient complete clearance per patients side. The 1-year overall lesion recurrence rate with BF-200 ALA was 14.1% versus 27.4% for vehicle/PDT. Patients reported comparatively higher satisfaction with the cosmetic outcome of BF-200 ALA/PDT. Meanwhile, the adverse events were consistent with the known safety profile of BF-200 ALA/PDT.

In conclusion, BF-200 ALA was well-tolerated and conferred notably higher AK clearance rates on extremities, trunk and neck than on the vehicle.

Source: Ulrich M, Reinhold U, Dominicus R, et al. Red light photodynamic therapy with BF-200 ALA showed superior efficacy in the treatment of actinic keratosis on the extremities, trunk, and neck in a vehicle-controlled phase III study. J Am Acad Dermatol. 2021;85(6):1510-9.