Body Contouring with Injection Adipocytolysis Utilizing Rzl-012 for Fat Reduction in the Flanks
Methods/Technique: In the flanks phase 2a double-blind study, a total of 12 subjects aged 18-65 years with clearly visible and palpable fat in the flanks were enrolled at a single site in the United States. At the baseline visit subjects received a single treatment session that consisted of 55 injections of RZL-012 (7.5 mg per injection) in 1 flank and placebo in the contralateral flank and then were followed for safety and efficacy over 12 weeks. At the completion of the 12-week follow-up, 9 subjects chose to participate in an additional 12-week open-label phase of the study and be treated with RZL-012 in the flank that was originally treated with placebo.
Results/Complications: In the double-blind phase, physician evaluation 12 weeks after injection showed that 63% of flanks treated with RZL-012 had marked improvement and 18% had moderate improvement. Additionally, 82% of the subjects were satisfied. In the open-label phase, physician evaluation 12 weeks after injection showed that 22% of flanks had moderate improvement and 78% had slight improvement; 67% of subjects were satisfied. There were no serious adverse events, and the injection site reactions resolved spontaneously, generally in less than 1 week.
Conclusion: Administration of RZL-012 into the flanks was well-tolerated and resulted in significant improvement in flank fat appearance as assessed by treating clinicians and treated subjects. This report represents the first proof of concept, phase 2a study with the investigative product for body contouring.