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Randomized Sham-Controlled Trial to Evaluate the Safety and Effectiveness of a High-Intensity Focused Ultrasound Device for Noninvasive Body Sculpting

Jewell, Mark L. M.D.; Baxter, Richard A. M.D.; Cox, Sue Ellen M.D.; Donofrio, Lisa M. M.D.; Dover, Jeffrey S. M.D.; Glogau, Richard G. M.D.; Kane, Michael A. M.D.; Weiss, Robert A. M.D.; Martin, Patrick B.S.; Schlessinger, Joel M.D.

Plastic & Reconstructive Surgery: July 2011 - Volume 128 - Issue 1 - pp 253-262
doi: 10.1097/PRS.0b013e3182174278
Cosmetic: Original Articles
Discussion
Press Release

Background: High-intensity focused ultrasound presents a noninvasive approach to body sculpting for nonobese patients. The purpose of this study was to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for sculpting of the abdomen and flanks.

Methods: Adults (aged 18 to 65 years) with subcutaneous abdominal fat greater than or equal to 2.5 cm thick who met screening criteria were randomized to receive high-intensity focused ultrasound treatment of the anterior abdomen and flanks at energy levels (a total of three passes each) of 47 J/cm2 (141 J/cm2 total), 59 J/cm2 (177 J/cm2), or 0 J/cm2 (no energy applied, sham control). The primary endpoint was change from baseline waist circumference at the iliac crest level at posttreatment week 12. Subjective aesthetic assessments included the Global Aesthetic Improvement Scale and a patient satisfaction questionnaire. Safety assessments included adverse events, laboratory values, and physical examinations.

Results: For the primary endpoint, in the intent-to-treat population, statistical significance versus sham was achieved for the 59-J/cm2 (–2.44; p = 0.01) but not the 47-J/cm2 treatment group (–2.06 cm; p = 0.13). In a per-protocol population, statistical significance versus sham was achieved for both the 59-J/cm2 (–2.52 cm; p = 0.002) and the 47-J/cm2 treatment groups (–2.10 cm; p = 0.04). Investigator subjective measures of global aesthetic improvement and patient satisfaction also favored each active treatment versus sham. Adverse events included mild to moderate discomfort, bruising, and edema. Laboratory values and physical examinations were unremarkable.

Conclusions: Treatment with this high-intensity focused ultrasound device reduced waist circumference and was generally well tolerated for noninvasive body sculpting. Reduction in waist circumference was statistically significant with both active treatments (per protocol).

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

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Eugene, Ore.; Mountlake Terrace, Wash.; Chapel Hill, N.C.; New Haven, Conn.; Chestnut Hill, Mass.; San Francisco, Calif.; New York, N.Y.; Hunt Valley, Md.; Scottsdale, Ariz.; and Omaha, Neb.

From Oregon Health Science University; Cosmetic and Reconstructive Plastic Surgery; Aesthetic Solutions; The Savin Center; Skin Care Physicians; private practice; the Maryland Laser, Skin, and Vein Institute; Medicis Technologies Corporation; and the Advanced Skin Research Center.

Received for publication December 16, 2010; accepted January 7, 2011.

Presented in part at the 6th European Masters in Aesthetic and Anti-aging Medicine, in Paris, France, October 15 through 17, 2010; the American Society for Dermatologic Surgery Annual Meeting, in Chicago, Illinois, October 21 through 24, 2010; World Congress on Controversies in Plastic Surgery and Dermatology, in Barcelona, Spain, November 4 through 7, 2010; the International Master Course on Aging Skin Annual Meeting, in Paris, France, January 6 through 9, 2011; the American Academy of Cosmetic Surgery 27th Annual Scientific Meeting, in Phoenix, Arizona, January 12 through 16, 2011; and the Winter Clinical Dermatology Conference, in Kohala Coast, Hawaii, January 14 through 19, 2011.

Disclosures: Financial support was provided by Medicis Technologies Corporation, Scottsdale, Ariz. Dr. Jewell has served as a consultant for Allergan, AorTech, Medicis, and Sound Surgical. He has received grants for clinical research from Allergan, Medicis, and Mentor and has received grants for educational activities from Medicis. Dr. Baxter has served as a consultant to Allergan, Lifecell, and Medicis. Dr. Cox has received grants for clinical research from Allergan and Medicis; has served as a principal investigator for Allergan, Medicis, and Revance; has served as a consultant to Allergan, Medicis, Johnson & Johnson, and Merz; and has served as an advisor for Allergan and Medicis. Dr. Donofrio has received grant/research support from Allergan, Cynosure, Medicis, Mentor, and Merz; has served as a consultant for Medicis, Niadyne, and Vichy; has been on speakers bureaus for Mentor and Vichy; and has served on an advisory board for Medicis. Dr. Dover has served as an advisor or consultant for Iridex Corporation, Zeltiq, Lumenis, Medicis, Shaser, and Solta Medical; has received grants for clinical research from Allergan, Cynosure, Lumenis, Medicis, Merz Pharma, OpusMed, Palomar, Shaser, Syneron, and Solta Medical; and owns stock, stock options, or bonds from CVS/Skin Effects and Shaser. Dr. Glogau has served as an advisor or consultant for Allergan, Medicis, Revance, Liposonix, and Lumenis; has received grants for clinical research from Allergan, Medicis, Revance, and Liposonix; and does not own stock, stock options, or bonds from any of the companies. Dr. Kane has served as an advisor or consultant for Allergan, BioForm Medical, Medicis, QMed, and Stiefel Laboratories; has served as a speaker or a member of a speaker's bureau for Allergan, Medicis, QMed, and Sanofi-Aventis; has received grants for clinical research from Coapt Systems, Medicis, and Revance Therapeutics; and owns stock, stock options, or bonds from Allergan, Medicis, and Revance. Dr. Weiss has received grant/research support from Medicis, Palomar, Ultrashape, and Zeltiq; has served as a consultant for Cooltouch and Medicis; has been on speakers bureaus for Allergan, Colbar, Cooltouch, Johnson & Johnson, and Palomar; and is a stockholder in Cooltouch. Patrick Martin is an employee of Medicis Technologies Corporation. Dr. Schlessinger has served on an advisory board or as a consultant to Abbott Pharma, Allergan, Amgen, Artes, Dermik, Galderma, Genentech, GSK/Stiefel, Kythera, Medicis, Mentor, Merz, Novartis, Obagi, and Ortho Pharma (Johnson & Johnson); has served as a researcher for 3M Pharma, Abbott Pharma, Allergan, Amgen, Astellas, Barrier Therapeutics, Biogen, Centocor, Clay-Park Labs, Collagenix, Connetics, Dermik, Dow, Lumenis, Galderma, Genentech, GSK/Stiefel, Glenmark Pharma, HealthPoint, Immunex, Kythera, Medicis, Mentor, Merz, Novartis, Novum, Nucryst, Ortho Pharma (Johnson & Johnson), Penederm Pharma, Perrigo, Pfizer, QLT USA, Regeneratio Pharma AG, Sandoz, Schering-Plough, Stiefel Labs, and UBC/Vitae; and is a stockholder in Allergan, Revance, Excel Cosmeceuticals, Medicis, and Obagi.

Mark L. Jewell, M.D., Jewell Plastic Surgery Center, 10 Coburg Road, Suite 300, Eugene, Ore. 97401, mjewell@teleport.com

©2011American Society of Plastic Surgeons