Roy G Geronemus1, Suzanne L Kilmer2, Simeon H Wall3, Jeremy B Green4, Joel L Cohen5, Robert A Weiss6, Tina S Alster7, Michael S Kaminer8, Anjali Gupta9. 1. Laser and Skin Surgery of New York, New York, New York. 2. Laser and Skin Surgery Center of Northern, California, Sacramento, California. 3. The Wall Center for Plastic Surgery, Shreveport, Louisiana. 4. Skin Associates of South Florida, Coral Gables, Florida. 5. AboutSkin Research, LLC, Englewood, Colorado. 6. Maryland Laser Skin and Vein, Hunt Valley, Maryland. 7. Washington Institute of Dermatological Laser Surgery, Washington, DC. 8. SkinCare Physicians, Chestnut Hill, Massachusetts. 9. Ulthera, Inc.
Abstract
BACKGROUND: Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance. METHODS: Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study. RESULTS: The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance. CONCLUSION: This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.
BACKGROUND: Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance. METHODS: Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study. RESULTS: The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance. CONCLUSION: This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.