Juvéderm injectable gel: a multicenter, double-blind, randomized study of safety and effectiveness.

4 Large controlled trial

What this means for you: this demonstrably works.

Type of study: controlled trial
Studied in: people
Participants: 292
Published: 2009 in Aesthetic surgery journal
Cited: 15 times by other research
Who paid: Not declared. PubMed carries no conflict-of-interest statement for most articles; that is not the same as independent.
Source: PubMed 19083502 · doi 10.1016/j.asj.2007.09.005

The plain-language write-up of this study is still being written. Below is the abstract exactly as the researchers published it.

Abstract by the researchers — original text

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.