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Review of Key Belotero Balance Safety and Efficacy Trials

Lorenc, Z. Paul M.D.; Fagien, Steven M.D.; Flynn, Timothy C. M.D.; Waldorf, Heidi A. M.D.

Plastic and Reconstructive Surgery: October 2013 - Volume 132 - Issue 4S-2 - p 33S–40S
doi: 10.1097/PRS.0b013e31829a07d5
Cosmetic: Original Articles

Summary: Belotero Balance is a novel highly cross-linked hyaluronic acid that uses cohesive polydensified matrix technology to achieve cohesive gel; improved adaptation by the dermis; and a soft, smooth fill. Several studies have now compared Belotero Balance to bovine collagen and other hyaluronic acids. Two pivotal studies demonstrated the noninferiority and superiority of Belotero Balance to bovine collagen. In the first study, more than half of the patients maintained optimal correction at 6 months on the Belotero-treated side of the face. The second of those two studies followed patients to week 96 and demonstrated that the effects of Belotero Balance in this long-term, open-label study persisted in the majority of subjects without repeated treatment for at least one interval of 48 weeks. The filler was well tolerated, with only one of 34 total adverse events (injection-site bruising) considered to be related to the study device. A third study compared the safety and efficacy of other hyaluronic acids (i.e., Juvéderm and Restylane) with Belotero Balance. In this study, the safety profiles of all three hyaluronic acids were generally favorable, with site-specific adverse events mild to moderate and comparable across each hyaluronic acid. Aesthetic results were also similar, although Belotero Balance resulted in greater evenness than Restylane at 4 weeks by one indicator used in the study. Finally, a 5-year retrospective safety review of 317 patients treated with Belotero Balance over a 5-year period revealed no severe adverse events in any patients, including the absence of persistent nodules or granulomas.

New York and Nanuet, N.Y.; Boca Raton, Fla.; and Cary, N.C.

From private practice; and Mount Sinai School of Medicine.

Received for publication March 6, 2013; accepted May 1, 2013.

Disclosure:Dr. Lorenc is a consultant for Mentor, Merz Aesthetics, Medicis, and Johnson & Johnson. Dr. Fagien is an advisory board member and investigator for Allergan, Medicis, Merz Aesthetics, and Galderma. Dr. Flynn is a physician in private practice and a consultant for Merz and Canfield Scientific. Dr. Waldorf is an advisory board member, consultant, and speakers’ bureau member for Merz Aesthetics, Medicis, Allergan, Valeant, Solta, Bropelle, P&G, Johnson & Johnson, Unilever, and Kythera.

Z. Paul Lorenc, M.D., Lorenc Aesthetic Plastic Surgery Center, 983 Park Avenue, New York, N.Y. 10028, lorenc@lorenc.com

©2013American Society of Plastic Surgeons