Biofrontera Ameluz Clinical Trial Results Show Significant Efficacy
Biofrontera announced results of its Phase 2b clinical trial evaluating Ameluz topical gel, 10% PDT for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study compared Ameluz and vehicle gel using two incubation times prior to illumination with the BF-RhodoLED lamp. Participants received one tube of Ameluz or vehicle gel applied to the entire face, followed by incubation and illumination with the red light. Up to three PDT treatments were administered at one-month intervals, and patients were followed up for two months after receiving the final PDT treatment. The study had co-primary endpoints, one of which looked at the relative reduction in inflammatory lesion counts. The other required an improvement of at least two grades on a 5-point modified Investigator Global Assessment scale and that the patient was rated "clear" or "almost clear". Greater improvements in both inflammatory lesion counts and mIGA scores were observed with Ameluz vs. vehicle with the 3-hour incubation regimen, identifying this as the most promising protocol for further clinical investigation in acne vulgaris. In the 3-hour per-protocol population, the Ameluz group achieved a 57.97% reduction in inflammatory lesions, compared with 36.51% in the corresponding vehicle group. For the mIGA analysis, 25% of the Ameluz treated patients met this co-primary endpoint with 21.4% of the vehicle patients achieving the same outcome. Reductions in absolute lesion counts further supported the efficacy of the 3-hour regimen. The values for inflammatory, non-inflammatory and total lesion reductions were 19.7, 23.1 and 42.7 with Ameluz vs. 15.4, 16.5 and 31.9 with vehicle. Ameluz PDT demonstrated a favorable safety profile consistent with previously reported photodynamic therapy experience. The most frequently reported treatment-related adverse events were burning sensation and pruritus, both of which were generally mild to moderate in severity. In addition, the average pain scores during the 3-hour incubation PDT treatments were modest, with the values in the Ameluz group ranging from 3.4 to 3.8, and from 2.0 to 2.1 with vehicle on an 11-point scale. Participants reported high overall satisfaction with PDT treatment. Of the patients who underwent the 3-hour Ameluz incubation, 85.7% said they would choose PDT again and 71.4% of them rated their esthetic outcome as "good" or "very good".
