Improvement in Cellulite Appearance After a Single Treatment Visit With Acoustic Subcision: Long-Term Findings From a Multicenter Clinical Trial.

Of 67 enrolled and treated participants, 25 were lost to follow-up, exclusionary criteria, or camera malfunction at the >52-week follow-up visit. A total of 42 participants were included in the efficacy and safety analyses. The mean age and BMI of participants was 43.5 years and 23.9 kg/m 2 , respectively. Table 1 provides a summary of participant demographics at the 12- and >52-week follow-up visits. 23 Participant Demographics and Baseline Characteristics BMI, body mass index. The efficacy results are shown in Table 2 . At least 2 of the 3 blinded reviewers correctly identified the >52-week post-treatment photographs at a rate of 95.2% when presented with random pre-/post-treatment photographs ( p 1-point reduction in CSS score from baseline, with a mean CSS score reduction of 1.09 ( p 1-point reduction in CSS score at 12 weeks post-treatment versus >52-weeks ( p > .05; Mann–Whitney U test). Representative participant photographs of cellulite appearance and severity at baseline, 12 weeks, and >52 weeks are shown in Figures 1 , 2 . Short-Term and Long-Term Efficacy Results CSS, cellulite severity score; ID, identification; Tx, treatment. Photographs of a representative participant showing (left to right) baseline cellulite severity (CSS = 3.33) and improvement after 12 (CSS = 2.33) and >52 weeks (CSS = 1.67). (Age: 44; baseline weight: 138 lbs; >52-week weight: 132 lbs). CSS scores are derived from independent panel review assessment. Photographs of a representative participant showing (left to right) baseline cellulite severity (CSS = 3.33) and improvement after 12 (CSS = 1.67) and >52 weeks (CSS = 1.67). (Age: 37; baseline weight: 185 lbs; >52-week weight: 177 lbs). CSS scores are derived from independent panel review assessment. The secondary long-term efficacy endpoint for participant satisfaction was met. When comparing side-by-side before and after photographs, 100% ( n = 42/42) of participants agreed that the treated area had improved in appearance (Figure 3 ). In addition, 97.6% ( n = 41/42) of participants felt there was good improvement in the appearance of their cellulite and 78.6% ( n = 33/42) agreed that the RAP treatment was relatively pain-free. Participant satisfaction with cellulite appearance at 12- and >52-week follow-up visits. Participants rated their level of agreement with the statement “In comparison to the pretreatment photo, the 52-week photograph of the treatment area appears improved” compared with baseline on a 5-point Likert scale from strongly agree to strongly disagree. The 12-week data have previously been reported. 23 Immediately after treatment, 85.7% ( n = 48/56) of participants reported an expected AE attributable to device or treatment, including mild-to-moderate erythema (76.7%, n = 43), mild pain (1.7%; n = 6), mild heat (1.7%, n = 2), and mild contusion/bruise (5.3%; n = 4). All expected AEs were resolved without intervention. At the >52-week follow-up visit, no new device or treatment-related AEs were reported. Furthermore, no participant reported any SAEs. Three participants reported UAEs at the >52-week follow-up visit, but they were determined to be unrelated to the acoustic subcision treatment or device. One report involved the discovery of a hernia, which was resolved surgically as a day case. Two other participants had endometriosis or gastroesophageal reflux disease, respectively, which was documented as continuing as of May 2021. None of the participants discontinued the study because of UAEs. Thus, the primary safety endpoint was met. Most participants (97.6%, n = 41/42) agreed that RAP treatment was tolerable (See Supplemental Digital Content 1 , Table 1, http://links.lww.com/DSS/B334 ), and participant-rated mean pain scores were 2.4 during 1-minute treatment doses and 0.3 immediately after the treatment visit (See Supplemental Digital Content 1 , Table 2, http://links.lww.com/DSS/B334 ).

The acoustic subcision device is an effective and well-tolerated RAP treatment for long-term improvement in the appearance of cellulite. These results build upon the 12-week results and show that a single treatment visit can provide long-term improvement up to approximately 52 weeks.

In this prospective, multicenter study, significant long-term improvement in the appearance of cellulite following a single, noninvasive RAP treatment was shown in patients with moderate to severe cellulite. Blinded reviewers correctly identified post-treatment photographs at a rate of 95.2%, further supporting the long-term efficacy of the acoustic subcision device. The long-term durability of the RAP treatment was shown by 70.4% of participants having a >1-point reduction in the CSS score compared with baseline and a mean CSS score reduction of 1.09. In comparison, at 12 weeks, 80.4% of participants had a >1-point reduction in CSS score and a mean decrease in score of 1.01. 23 The difference in mean CSS reduction scores between 12 weeks and >52 weeks was not statistically significant after a direct comparison of 12-week and >52-week photographs by the blinded reviewers. Significant improvements were observed in participant satisfaction ratings of cellulite appearance after treatment, indicating that the improvements seem durable. Similar patterns were observed in participants' rated feelings about the treatment results. Previous studies have indicated that women with cellulite often experience psychological distress and low self-esteem, particularly in social settings. 12 , 13 Future studies that elucidate the potential impact of RAP treatment on psychological distress and quality of life are warranted. Treatment with the acoustic subcision device was also well-tolerated, as evidenced by the lack of device or treatment-related UAEs or SAEs in participants. The level of participant-reported pain was low during treatment (mean score of 2.4 on a 0–10 scale) and was minimal immediately after treatment (mean score of 0.3), which is lower than that reported in a multicenter trial using mechanical subcision. 14 Several studies have demonstrated the long-term efficacy of invasive treatments. In a multicenter study evaluating cellulite improvement in 57 female participants after laser-assisted subcision, 76% of participants demonstrated a ≥1-point improvement in dimple count or contour irregularity at 2 months post-treatment, with 90% of treated areas maintaining results after 1 year 27 In another study, Kaminer and colleagues found that improvements in cellulite appearance and patient satisfaction were maintained for up to 3 years after treatment with a tissue-stabilized guided subcision device, although patients must be anesthetized before treatment. 14 , 17 These invasive treatments have demonstrated long-term efficacy, but have varying degrees of effectiveness and require the delivery of localized anesthesia, compression garments postprocedure, and avoidance of certain activities for up to 2 weeks. 14 – 16 , 27 Another potential drawback is that the operation of these devices requires a skilled physician to ensure an adequate treatment depth is chosen. 28 In contrast, treatment with the acoustic subcision device is noninvasive, eliminating the need to determine treatment depth, anesthetize treatment areas, or counsel patients on post-treatment activities to avoid. One potential limitation of this study is the lack of a true control group. All participants received the treatment, thus limiting the comparability of participant photos. Another limitation is that each participant only underwent a single treatment visit, regardless of the severity of the cellulite. Additional treatment visits may be more beneficial to ensure the durability of improvements in cellulite appearance, but further studies are required to evaluate this. In addition, participants' Fitzpatrick skin phototype was not noted, thereby limiting knowledge of the acoustic subcision device's effectiveness in various skin types. The lack of skin laxity measurement is also a limitation, because improvements in cellulite appearance may influence this aesthetic characteristic. The nature of the study design did not allow for differentiation between the effectiveness of the acoustic subcision device on the buttocks versus the thighs. Future studies should focus on assessing differences between these treatment areas, because the thighs are generally more difficult to treat from a clinical perspective. When comparing the assessment of the severity of cellulite for eligibility and then for an assessment of efficacy, a difference in severity scoring was noted—implying the importance of physical assessment in addition to photography to assess the severity of cellulite in the clinical setting accurately. Finally, the trial was conducted during the COVID-19 pandemic, resulting in challenges when scheduling follow-up visits. Stay-at-home orders, lockdowns, and participant self-quarantine increased the number of “no-show” visits, thereby contributing to the dropout rate between the 12-week and >52-week follow-up visits.

This was a prospective, single-arm, self-controlled, multicenter trial conducted at 4 US sites from July 2019 through December 2020. This study conformed to the ethical guidelines of the 1975 Declaration of Helsinki. Institutional Review Board (IRB) approval was obtained from Quorum Review IRB (Seattle, WA). All participants provided informed consent before treatment. This study is registered at ClinicalTrials.gov (NCT#04065711). This study comprised 4 visits: screening, a single treatment visit, and follow-up visits at 12- and >52-weeks post-treatment. As a result of the COVID-19 pandemic, several participants were unable to attend follow-up visits because of stay-at-home orders, lockdowns, or COVID-19 exposure, resulting in follow-up visits beyond the 52-week time-point. Eligible participants were females (≥18–50 years; BMI ≤30 kg/m 2 ) who had severe cellulite (≥4.0) as assessed by the clinical investigators on a validated 6-point Cellulite Severity Scale (CSS; See Supplemental Digital Content 1 , Figure 1, http://links.lww.com/DSS/B334 ) 26 at baseline, on at least 1 thigh and/or buttock (scale of 0–5; 0 = none, 1–2 = mild, 3 = moderate, 4–5 = severe). Additional inclusion criteria included: weight (±5% of body weight) stable for at least 6 months before the study; no invasive or energy-based cellulite treatments (e.g., liposuction, subcision, laser) for the previous 12 months; and no use of topical-based cellulite treatments for the previous 6 months. Key exclusion criteria included: current pregnancy or planning to become pregnant during the duration of the study; metal or plastic implants in the area of the treatment (e.g., vascular stent, or implants in the hips, knees, etc); active electronic implants (e.g., pacemakers, defibrillators); a medical disorder that would hinder wound healing or immune response (e.g., blood disorder, inflammatory disease, etc); coagulopathy(ies) and/or is on anticoagulant medication; skin disorders (e.g., skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area; any surgical procedure in the previous 3 months, or planned in the duration of the study; and current smoker. The acoustic subcision device was used to administer a single RAP treatment during a single treatment visit after completion of screening, enrollment, and obtaining informed consent from each participant. The investigator selected the right or left buttock/thigh with the most marked or severe cellulite and outlined (or demarcated) regional treatment areas (i.e., depressions, dimples, and ridges). After completion of the study, participants were offered 1 treatment visit to treat the untreated buttock/thigh after commercial availability. The baseline buttock/thigh photographs of the treated area served as the control. The participant was then positioned in the lateral decubitus or prone position and an acoustic coupling hydrogel pad and hydrogel was applied to the marked treatment areas. Participants did not receive anesthesia or other pain medications before, during, or after the procedure. One to 2 1-minute RAP doses were administered at a pulse rate of 50 Hz to each treatment area. The total number of treatment doses was determined by the number of identified treatment areas. Additional 1-minute doses were administered to deep dimples and ridges and to areas between and around the marked treatment areas. Treatment areas were cleaned immediately post-treatment and evaluated for any adverse events (AEs). No post-treatment bandages, compressions garments, or other care were needed. Post-treatment photography was taken at 12-week and 52-week visits; the mean time for the 52-week visit was 59.7 weeks (range: 52.0–67.0 weeks). Three blinded, independent, board-certified dermatologists (reviewers) identified post-treatment images from randomly ordered side-by-side baseline and >52-week photographs, then graded the baseline and post-treatment images using a simplified 6-point CSS (scale of 0–5, with 5 being the most severe). 26 The percentage of participants with a ≥1- point change in CSS score at the 12- and >52-week follow-up visit was also calculated. The primary efficacy endpoint was correct identification of the >52-week post-treatment photographs from baseline photographs by at least 2 of 3 blinded reviewers at an average rate of ≥80%. Serial clinical photographs (QuantiCare 3D LifeViz stereoscopic camera system) were collected at baseline and the 12- and >52-week post-treatment time-points. Participants stood on a rotatable platform in a relaxed position and photographs were taken of the thighs, buttocks, and the thighs and buttocks together from 8 angles. Photographs were taken under standardized conditions, including the angle of the lights and the distance between the platform, lights, and camera. Finally, after reviewing their own baseline and >52-week post-treatment photographs, participants were given a satisfaction survey and asked to rate their level of agreement with the following statement, “In comparison to the pretreatment photo, the 52-week photograph of the treatment area appears improved,” using a 5-point Likert scale from “strongly agree” to “strongly disagree.” Agreement was defined as responses of “strongly agree” or “agree.” The secondary efficacy endpoint was met if ≥80% study participants agreed that the appearance of their cellulite was improved post-treatment. Participants were also asked to respond to the following statements using the same 5-point Likert scale, “I feel there is good improvement in the appearance of my cellulite” and “the RAP treatment was relatively pain-free.” Immediately after treatment, the participants were evaluated for AEs. Expected AEs included mild-to-moderate erythema, mild pain, mild heat, and mild bruising or contusions. The primary safety endpoint was that there would be freedom from unexpected AEs (UAEs) or serious AEs (SAEs) directly attributable to the device or treatment immediately after acoustic subcision treatment throughout the conduct of the study. In addition, participants were asked to grade pain during and after the procedure on a scale from 0 (no pain) to 10 (worst pain possible). Finally, participants were asked to respond “yes” or “no” to the following question on a procedure tolerability questionnaire, “was the RAP treatment procedure tolerable?” Baseline and >52-week data are summarized descriptively. The primary efficacy endpoint, the rate of correct identification by at least 2 of the 3 blinded reviewers, was assessed for statistical significance using the χ 2 test. The difference in baseline and long-term (>52-week) CSS scores was assessed using the Student t -test (paired, two-sided). Statistical significance was set at p < .05 (See Supplemental Digital Content 2 , Appendix 1, http://links.lww.com/DSS/B367 ).