Elizabeth Tanzi, Michael Kaminer, Brenda LaTowsky, Omer Ibrahim
Background: A rapid acoustic pulse (RAP) device produces high intensity acoustic shock waves at 50 Hz has potential to improve the appearance of cellulite through disruption of the subcutaneous fibrous structures (i.e. acoustic subcision). In a prior proof-of-concept (POC) study, appearance of cellulite in five patients improved following a single RAP session1,2. A multi-center pivotal study was initiated and is ongoing. Interim safety, tolerability and efficacy results are provided.
Type of Study: IRB approved multi-center prospective pivotal clinical trial. Interim findings.
Methods: Grade II cellulite in 67 women was treated in a single 19-33 minute RAP session. Adverse events and tolerability were recorded after treatment. Results from 12- week followup of the first 26 patients were evaluated. Preliminary assessment of efficacy was measure by having four blinded medical professionals correctly identify the 12-week post-treatment photographs from randomly placed side-by-side comparison of before/after photographs.
Results: No adverse events were noted other than mild erythema at treatment sites. Overall pain score during RAP treatment was 2.4 (1-10 pain scale with 10 being the worse). For the first 26 patients, the blinded panel correctly identified the 12-week post-treatment photographs at a rate of 94.2%.
Published Date: 2020-08-31;