For patients with mild-to-severe actinic keratoses (AK) located on the extremities, trunk, and neck, nanoemulsion gel formulation containing 7.8 percent 5-aminolevulinic acid (BF-200 ALA) has superior efficacy compared with vehicle, according to a phase III study published in the December issue of the Journal of the American Academy of Dermatology .

Martina Ulrich, M.D., from the CMB Collegium Medicum Berlin GmbH in Germany, and colleagues examined the efficacy and safety of BF-200 ALA compared to vehicle for the treatment of mild-to-severe AK located on the extremities, trunk, and neck in an intraindividual study conducted among 50 patients in six centers in Germany. Each patient received treatment with BF-200 ALA/red light photodynamic therapy (PDT) and vehicle/PDT on opposite sides, with a maximum of two PDTs.

The researchers found that with respect to total lesion clearance rates (86.0 versus 32.9 percent) and patient complete clearance per patient's side (67.3 versus 12.2 percent), BF-200 ALA was superior to vehicle. The overall lesion recurrence rates at one year were 14.1 and 27.4 percent for BF-200 ALA and vehicle, respectively. Patient satisfaction with the cosmetic outcome was higher with BF-200 ALA/PDT than vehicle/PDT. Adverse events in association with BF-200 ALA/PDT were consistent with the known safety profile.

"In line with our previous studies, the results demonstrated high efficacy with superiority to vehicle and confirmed good safety and tolerability and excellent cosmetic outcome," the authors write.

Several authors disclosed financial ties to biopharmaceutical companies, including Biofrontera Bioscience GmbH, which funded the study.

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