Background: -trimethylpentan-1-aminium chloride) is a novel injectable cytolytic agent in development for aesthetic and therapeutic indications. This open-label phase 2 study evaluated the safety and efficacy of repeat treatment with RZL-012 for the reduction of submental fat (SMF) in patients previously treated and seeking additional improvement. Methods: Fifteen patients (18-65 y) who had received RZL-012 three to 24 months prior underwent a second treatment to the SMF area and were followed up for more than 84 days. SMF was assessed at baseline and posttreatment using the Clinician Chin Assessment Tool and Subject Chin Assessment Tool. Safety was evaluated through adverse event monitoring, and patient satisfaction was recorded. Results: All patients (15 of 15, 100%) achieved at least a 1-grade improvement on both Clinician Chin Assessment Tool and Subject Chin Assessment Tool relative to the original baseline (before first treatment), and 47% (7 of 15) achieved at least a 2-grade improvement. These outcomes exceeded those observed after initial treatment, in which 67% achieved at least a 1-grade improvement and none achieved at least a 2-grade improvement. Eighty percent of patients reported being "satisfied" or "very satisfied" with treatment outcomes. Adverse events were localized and consistent with prior studies. Conclusions: Repeat treatment with RZL-012 provides additional improvement in SMF appearance with favorable safety and tolerability, supporting its potential utility in patients seeking further aesthetic benefit.
Shridharani et al. (Wed,) studied this question.