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Juvéderm injectable gel: a multicenter, double-blind, randomized study of safety and effectiveness.
Mark A Pinsky1, Jane A Thomas, Diane K Murphy
1Private practice in West Palm Beach, FL, USA. mpinsky@pinskymd.com
Aesthetic Surgery Journal
|December 17, 2008
Summary
Juvéderm Ultra and Ultra Plus dermal fillers offer long-term wrinkle correction, with Juvéderm Ultra Plus providing over a year of effectiveness. Both formulations demonstrated safety and sustained results compared to traditional collagen treatments.
Area of Science:
- Dermatology
- Aesthetic Medicine
- Biomaterials Science
Background:
- Juvéderm dermal fillers utilize a high concentration of crosslinked hyaluronic acid (HA) in a smooth, malleable formulation.
- This study focuses on the novel Juvéderm Ultra and Ultra Plus injectable gel formulations.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of Juvéderm Ultra and Ultra Plus injectable gels.
- To compare the performance of Juvéderm against Zyplast collagen for nasolabial fold correction.
Main Methods:
- A multicenter, FDA-approved study randomized subjects to Juvéderm or Zyplast treatment in opposing nasolabial folds.
- Effectiveness was assessed using a 5-point scale over 6 months, with additional long-term follow-up.
- Safety was monitored via daily diaries for 14 days post-treatment.
Main Results:
- Both Juvéderm formulations showed clinically significant wrinkle correction beyond 9 months, unlike Zyplast.
- At over 9 months, 75% of Juvéderm Ultra and 81% of Juvéderm Ultra Plus treated sites maintained correction.
- Juvéderm Ultra Plus demonstrated sustained improvement in 78% of subjects beyond one year.
Conclusions:
- Juvéderm Ultra and Ultra Plus represent next-generation HA dermal fillers.
- These fillers reliably provide long-term correction, with Juvéderm Ultra lasting over 9 months and Juvéderm Ultra Plus lasting over a year.
- Treatment-site reactions were comparable between Juvéderm and Zyplast.
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