Biofrontera announced top-line results in its Phase 3 study of the use of Ameluz with the BF-RhodoLED lamp in the treatment of sBCC. The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments 1-2 weeks apart, repeated after three months, if required. The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle. Ameluz-PDT achieved 65.5% success in this rigorous target, compared to 4.8% success achieved with placebo-PDT. Complete histological clearance was seen in 75.9% of these lesions in the Ameluz arm, compared to 19.0% with placebo. Complete clinical clearance was achieved in 83.4% of patients treated with Ameluz compared to 21.4% with placebo. The results for all other secondary efficacy parameters were equally highly significant with, for instance, 64.1% of Ameluz-PDT patients achieving total clearance of all sBCC lesions compared to only 4.8% of those treated with placebo-PDT. Most patients who received Ameluz-PDT rated the overall treatment satisfaction and esthetic outcome as very good or good.
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