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.