Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial

Abstract

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.

Keywords: acoustic subcision; cellulite; improvement in appearance; laxity; noninvasive; rapid acoustic pulse.

Figure 1

Acoustic subcision device

Figure 2

Photograph of hand piece in use during application in a cellulite treatment session

Figure 3

Images of Participant 63 showing (left to right) baseline cellulite severity (CSS = 3.33) and improvement after 12 weeks (CSS = 2.33). (Baseline weight: 143.4 pounds, Week‐12 weight: 144.0 pounds). CSS, Cellulite Severity Scale

Figure 4

Images of Participant 57 showing (left to right) baseline cellulite severity (CSS = 5.00) and improvement after 12 weeks (CSS = 4.00). (Baseline weight: 186.0 pounds, Week‐12 weight: 192.4 pounds). CSS, Cellulite Severity Scale

Figure 5

Images of Participant 58 showing (left to right) baseline cellulite severity (CSS = 4.67) and improvement after 12 weeks (CSS = 3.67). (Baseline weight: 191.4 pounds, Week‐12 weight: 194.8 pounds). CSS, Cellulite Severity Scale

Figure 6

Images of Participant 26 showing (left to right) baseline cellulite severity (CSS = 4.33) and improvement after 12 weeks (CSS = 2.67). (Baseline weight: 138.0 pounds, Week‐12 weight: 140.0 pounds). CSS, Cellulite Severity Scale

Figure 7

Images of Participant 18 showing (left to right) baseline laxity score (LS = 1.33) and improvement after 12 weeks (LS = 0.33). (Baseline weight: 139.0 pounds, Week‐12 weight: 133.8 pounds). LS, Laxity Score

Figure 8

Fibrous septae disruption time‐dose response: Porcine adipose septae treated with an acoustic subcision device demonstrating increase disruption of fibrous septae with increasing 1‐min rapid acoustic pulse doses. (A) No treatment, (B) 1 min, (C) 2 min, and (D)3 min. Black bar = 50 microns

Figure 9

Dermal neocollagenesis: Herovici stained porcine reticular dermis from biopsies of sites treated with an acoustic subcision device. The 62‐days posttreatment histology image (right) demonstrates substantially greater amount of type II new collagen (light blue) in comparison to baseline histology image (left). White bar = 100 microns