Juvéderm injectable gel: a multicenter, double-blind, randomized study of safety and effectiveness.
BACKGROUND
A high concentration of crosslinked hyaluronic acid (HA) in a smooth, malleable formulation is the hallmark of the new Juvéderm dermal fillers.


OBJECTIVE
To determine the long-term effectiveness and safety of Juvéderm Ultra and Ultra Plus injectable gel.


METHODS
In the multicenter study approved by the Food and Drug Administration, subjects were randomized to treatment with Juvéderm Ultra or Ultra Plus in one nasolabial fold (NLF) and Zyplast collagen in the other. After optimal correction was achieved (treatment plus up to 2 touch-ups at 2-week intervals), effectiveness was assessed on a 5-point scale through the 6-month study period. An additional poststudy visit provided long-term effectiveness data. Safety was evaluated through subjects' daily diaries for 14 days after treatment.


RESULTS
A total of 292 subjects were randomized and treated, 146 in each cohort. A total of 280 subjects completed the 6-month study, and 227 attended the poststudy visit. Clinically significant mean wrinkle correction (>or= 1 point improvement) was still in evidence at >9 months for both Juvéderm formulations but not for the Zyplast control. At >9 months, 75% of Juvéderm Ultra- and 81% of Juvéderm Ultra Plus-treated NLFs maintained a clinically significant correction. Moreover, 78% of NLFs treated with Juvéderm Ultra Plus still had a clinically significant improvement beyond 1 year. Local treatment site reactions were comparable for Juvéderm and Zyplast.


CONCLUSIONS
These next-generation HA dermal fillers can be reliably expected to provide long-term correction, with Juvéderm Ultra lasting more than 9 months and Juvéderm Ultra Plus lasting for a year or more.
Pinsky
Mark A
MA
Private practice in West Palm Beach, FL, USA. mpinsky@pinskymd.com
Thomas
Jane A
JA
Murphy
Diane K
DK
Walker
Patricia S
PS
D000328:Adult; D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D003094:Collagen / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D003357:Cosmetic Techniques; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects; D007279:Injections, Subcutaneous; D008046:Lip; D008297:Male; D008875:Middle Aged; D009666:Nose; D011446:Prospective Studies; D012107:Research Design; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
D001672:Biocompatible Materials; C526061:Juvederm Ultra; C526062:Juvederm Ultra Plus; C048470:glutaraldehyde-cross-linked collagen; D006820:Hyaluronic Acid; D003094:Collagen