Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: Final Results at 12 Months

W Grant Stevens, Jeremy B Green, Craig Layt, Michael S Kaminer, Jennifer Harrington, Larry Fan, Holly Casey Wall, Sabrina Fabi, Mark R Magnusson
Safety and efficacy endpoints for the single-arm, multicenter, open-label pivotal study, CONtrolled Focal Fibrous Band Release Method (CONFFIRM) [NCT04743635] assessing Targeted Verifiable Subcision (TVS) for the treatment of cellulite were met at 3 months post-procedure and have been published. Final, 12 month data describing durability of treatment effect and safety are presented here for the first time. To evaluate safety and efficacy out to 12 months of initial treatment for a single TVS
more » ... cedure performed using the Avéli device (Revelle Aesthetics, Inc., Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females. Effectiveness was determined by 3 independent physicians using the Cellulite Severity Scale (CSS) and Global Aesthetic Improvement Scale (GAIS) to assess improvement of baseline photographs when compared to 3-, 6- and 12-months posttreatment photographs. Blinded participant-reported outcomes (PROs) and safety evaluations were also performed at all post-procedure time points. Clinically significant improvement in primary endpoint CSS scores were sustained out to 1 year, improving by 1.50 (p < .0001) at 3 months, 1.54 points at 6 months and 1.48 points at 12 months. Adverse events were mild and mostly resolved by the 12 month visit. A single TVS treatment has durable efficacy and safety in reducing cellulite on the buttocks and thighs of women with moderate to severe cellulite out to 12 months posttreatment.
doi:10.1093/asj/sjac291 pmid:36351188 fatcat:wp5xhxf5rjgutbmgwzrgowgezm