Review of key Belotero Balance safety and efficacy trials.
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.
Z Paul
ZP
Lorenc
Steven
S
Fagien
Timothy C
TC
Flynn
Heidi A
HA
Waldorf
D002986:Clinical Trials as Topic; D003357:Cosmetic Techniques; D006801:Humans; D006820:Hyaluronic Acid / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use*; D060052:Nasolabial Fold; D016896:Treatment Outcome
C526061:Juvederm Ultra; C584568:belotero balance; D006820:Hyaluronic Acid; C445361:Restylane