Three-Dimensional Analysis of Minimally Invasive Vacuum-Assisted Subcision Treatment of Cellulite

September 2018 | Volume 17 | Issue 9 | Original Article | 960 | Copyright © September 2018


Jeremy A. Brauer MD,a,b Mitalee P. Christman MD,b Yoon Soo C. Bae MD,a,b Leonard J. Bernstein MD,a,c Robert Anolik MD,a,b Ron Shelton MD,a,d Roy G. Geronemus MDa,b

aLaser & Skin Surgery Center of New York, New York, NY bRonald O. Perelman Department of Dermatology, New York University School of Medicine, New York, NY cDepartment of Dermatology, New York Weill Cornell Medical College, New York, NY dDepartment of Dermatology, Mount Sinai School of Medicine, New York, NY

Abstract
Introduction: This was a prospective non-randomized observational study of female subjects seeking treatment for cellulite who were consecutively enrolled into a registry. The objective was to evaluate the efficacy and safety of a tissue stabilized-guided subcision device for the treatment of cellulite using three-dimensional (3D) imaging analysis. Methods: Subjects received a single treatment to the buttocks and/or posterolateral thighs with the study device. Follow-up telephone evaluations were conducted at 3 and 14 days to evaluate safety and 30 and 90 days to evaluate efficacy. Subjects returned to clinic at three months to obtain follow-up two dimensional and 3D imaging. Results: Sixteen women of average age 44.1 years with a total of 291 lesions of cellulite were treated. Thirteen subjects presented for all follow up visits. Physicians graded results an average of 2.23/5 or “much improved” to “improved” with 9 subjects as much or very much improved (69.2%). Blinded assessors graded overall improvement an average of 2.8 (26-75% improvement) with 8 subjects having greater than 50% improvement overall (61.6%). Improvement in dimple depth was graded an average of 2.9, with 9 subjects having greater than 50% improvement (69.2%). Analysis of 3D imaging yielded 67.4% average improvement in negative volume and 58.4% improvement in minimum height of dimples. Most expected treatment effects resolved within three months after treatment. Conclusion: Utilizing three-dimensional imaging analysis, investigators quantitatively and objectively demonstrated efficacy of a tissue stabilized-guided subcision device in the treatment of cellulite of the buttocks and thighs. J Drugs Dermatol. 2018;17(9):960-965.

INTRODUCTION

Cellulite is commonly observed as a rippling or dimpling of the skin on the thighs and buttocks in as many as 80-90% of post-pubertal women1. Although multiple etiologies may exist, an understanding of the anatomy of cellulite is crucial to guiding treatment.2 Normal skin has a support net- work of fibrous septae running through the subcutis, separating the adipose tissue into chambers resembling a quilt. Magnetic resonance imaging demonstrates that in cellulite, these fibrous septae are contracted and sclerosed, tethering the skin at a fixed length.3 Simultaneously, adipose cells expand with weight gain or water absorption, and in doing so herniate into the dermis, creating skin dimpling and the characteristic appearance of cellulite. Two distinct morphologies of cellulite may be identified, sometimes in the same patient.The first is diffuse rippling in pa- tients with increased adipose tissue and/or increased skin laxity – these patients may stand to benefit from lipolytic and skin tightening modalities.The second is dimpling, with discrete ellipsoid or linear depressions representing tethering by fibrous septae in patients with good skin tone – these patients stand to improve from subcision of fibrous septae by minimally invasive techniques such as tissue stabilized-guided subcision (TS-GS) (Cellfina® System, Merz North America, Inc., Raleigh, NC). TS- GS is approved by the United States Food and Drug Administra- tion for the long-term treatment of cellulite on the buttocks and thighs, with no reduction in benefits for 3 years of follow-up.4 Kaminer et al.5 recently reported the three-year results from treating 45 patients with a single treatment of the study device, demonstrating the safety and effectiveness of the device. Our goal was to augment these results with additional data from three-dimensional (3D) imaging analysis.

MATERIALS AND METHODS

As part of a larger registry study,6 we conducted a prospective non-randomized single center observational study of female subjects seeking treatment for cellulite. These subjects were consecutively enrolled into a registry within a multicenter study. The study was approved by the Asentral institutional review board (Protocol ULT-500). Subjects with unwanted cellulite of the buttocks and posterolateral thighs who met inclusion and exclusion criteria (Table 1) were enrolled in the study. Informed consent was obtained. 
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