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

Abstract

Background 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. Objectives To evaluate safety and efficacy out to 12 months of initial treatment for a single TVS procedure performed using the Avéli device (Revelle Aesthetics, Inc., Mountain View, CA) to treat cellulite on the buttock and thigh areas of adult females. Methods 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. Results 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. Conclusions 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.

Comparing Collagenase and Tissue Subcision for Cellulite Treatment of the Buttock and Thigh Regions: A Systematic Review and Meta-analysis

“…Twelve of our 14 studies were included in our statistical (quantitative) analysis; two studies (Goldman et al, 2015; Kamimer et al, 2019) could not be included as they did not report the relevant data. 6,16–26,28–32…”

“…Amore et al 22 using the CelluErase device had the longest postoperative compression treatment recommendation (1 month) in addition to multiple lymphatic drainage or pressure therapy sessions. [16][17][18][19][20][21][22][23][24] The minimally invasive targeted verifiable subcision using the Avéli device as described by Stevens et al 23 was the only study that did not recommend compression therapy of any kind, which might be explained by a lesser amount of skin incision necessary. [16][17][18][19][20][21][22]24…”

“…For instance, the CCH study by Sadick et al 29 reported more than 60% investigator and 70% patient satisfaction. 6,[16][17][18][19][20][21][22][23][24][25][26][27]29,31 The Cellulite Severity Score was used in four studies, whereas others used unique systems such as the Clinician-reported Photonumeric Cellulite Severity Scale and the Patient-reported Photonumeric Cellulite Severity Scale. An additional five studies reported on arbitrary patient satisfaction scales.…”

“…A total of 897 studies were identified during the initial screening process. After exclusion of duplicates and manual review against established criteria, 14 studies were included in the final analysis, with nine describing mechanical TS [16][17][18][19][20][21][22][23][24] and the remaining five describing CCH injection 6,25-28 (Fig. 1).…”

“…The Investigator Global Aesthetic Improvement Scale was the most frequently used, featured in seven of our 14 studies. 6,[16][17][18][19][20][21][22][23][24][25][26][27]29,31 This clinician-based evaluation measures cellulite appearance changes using before and after images. Similarly, the Subject Global Aesthetic Improvement Scale was used in five studies and used patient feedback.…”