PMID- 34224601 OWN - NLM STAT- MEDLINE DCOM- 20220127 LR - 20220731 IS - 1096-9101 (Electronic) IS - 0196-8092 (Print) IS - 0196-8092 (Linking) VI - 54 IP - 1 DP - 2022 Jan TI - Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial. PG - 121-128 LID - 10.1002/lsm.23448 [doi] AB - INTRODUCTION AND OBJECTIVES: Surface depressions and skin laxity together play a role in the appearance of cellulite. Cellulite depressions can be improved through disruption of the subcutaneous fibrous structures. Some currently utilized approaches accomplish this through invasive techniques requiring local anesthesia and potential down time. Skin laxity can exacerbate the appearance of cellulite, however current invasive approaches do little to improve skin laxity. The objective of this study was to evaluate a noninvasive approach to improving both cellulite depressions and skin laxity through the use of rapid acoustic pulses (acoustic subcision). Safety, efficacy, tolerability, and participant satisfaction results were measured. METHODS: Women (n = 56) with moderate to severe cellulite were treated in a single acoustic subcision treatment session without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12-weeks cellulite outcomes were assessed using a 6-point simplified Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and a participant satisfaction questionnaire. Additionally, laxity improvement was measured using a 4-point Laxity Score (LS) and GAIS. RESULTS: Improvement in cellulite appearance measured at 12-weeks showed that participants (n = 56) had a mean CSS reduction of 1.01 (a 29.5% reduction from baseline). The posttreatment photograph was correctly identified by blinded independent reviewers from randomized pairs of pre/posttreatment photographs for 96.4% of participants. Cellulite was graded as improved, much improved or very much improved using the GAIS at 90.9% of treated locations. Finally, 92.9% of participants reported positive satisfaction responses. Scoring for improvement in skin laxity appearance at 12-weeks showed a mean LS reduction of 0.57 (a 27.9% reduction from baseline). GAIS for laxity was graded as improved, much improved or very much improved in 67.3% of treated areas. No unexpected or serious AEs were noted at treatment or follow-up. Overall average pain score during treatment was 2.4 (0-10 pain scale) and 0.3 immediately posttreatment. CONCLUSION: A single noninvasive acoustic subcision session can safely provide meaningful improvement in the appearance of cellulite in terms of depressions, as well as skin laxity, with minimal treatment pain and no posttreatment down time. Further improvement in appearance is expected with multiple treatments over time. Additional trials to verify this are planned. CI - (c) 2021 The Authors. Genetic Epidemiology Published by Wiley Periodicals LLC. FAU - Tanzi, Elizabeth L AU - Tanzi EL AD - Capital Laser and Skin Care, Chevy Chase, Maryland, USA. FAU - Capelli, Christopher C AU - Capelli CC AD - Research, Soliton, Inc, Houston, Texas, USA. FAU - Robertson, David W AU - Robertson DW AUID- ORCID: 0000-0003-0149-0868 AD - Research, Soliton, Inc, Houston, Texas, USA. FAU - LaTowsky, Brenda AU - LaTowsky B AD - Clear Dermatology and Aesthetic Center, North Scottsdale, Arizona, USA. FAU - Jacob, Carolyn AU - Jacob C AD - Chicago Cosmetic Surgery and Dermatology, Chicago, Illinois, USA. FAU - Ibrahim, Omer AU - Ibrahim O AD - Chicago Cosmetic Surgery and Dermatology, Chicago, Illinois, USA. FAU - Kaminer, Michael S AU - Kaminer MS AD - SkinCare Physicians of Chestnut Hill, Chestnut Hill, Massachusetts, USA. LA - eng PT - Case Reports PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20210705 PL - United States TA - Lasers Surg Med JT - Lasers in surgery and medicine JID - 8007168 SB - IM MH - Acoustics MH - Buttocks MH - *Cellulite MH - *Cosmetic Techniques MH - Female MH - Humans MH - Patient Satisfaction MH - Thigh MH - Treatment Outcome PMC - PMC9292379 OTO - NOTNLM OT - acoustic subcision OT - cellulite OT - improvement in appearance OT - laxity OT - noninvasive OT - rapid acoustic pulse EDAT- 2021/07/06 06:00 MHDA- 2022/01/28 06:00 PMCR- 2022/07/18 CRDT- 2021/07/05 17:18 PHST- 2021/06/14 00:00 [accepted] PHST- 2021/07/06 06:00 [pubmed] PHST- 2022/01/28 06:00 [medline] PHST- 2021/07/05 17:18 [entrez] PHST- 2022/07/18 00:00 [pmc-release] AID - LSM23448 [pii] AID - 10.1002/lsm.23448 [doi] PST - ppublish SO - Lasers Surg Med. 2022 Jan;54(1):121-128. doi: 10.1002/lsm.23448. Epub 2021 Jul 5.