Clinical Information

With the approval of Juvéderm®, you can now offer a “next-generation” hyaluronic acid dermal filler to patients seeking treatment for moderate to severe facial wrinkles and folds, such as nasolabial folds and oral commissures. Juvéderm® injectable gel is a nonsurgical, physician-administered treatment made from the naturally occurring substance hyaluronic acid. There is minimal recovery or downtime and the risks of allergic reactions are minimal.

With JUVÉDERM® injectable gel, innovative HYLACROSS® technology provides:

Resistance to degradation

  • Clinically proven persistence up to 1 year in both formulations ¹
  • High concentration of hyaluronic acid (HA)
    • 24 mg/mL
  • High concentration of cross-linked HA

Smooth consistency gel for enhanced performance

Juvéderm® injectable gel is the only smooth consistency gel—other hyaluronic acid dermal fillers currently on the market are made of granular consistency gels.*

JUVÉDERM & Restylane

JUVÉDERM®                                              RESTYLANE†

*Dry test, extrusion of a small amount (≈.025 mL) of JUVÉDERM® injectable gel and RESTYLANE onto a glass surface at 9x magnification.

†RESTYLANE is a registered trademark of Q-Med AB.

JUVÉDERM® was the subject of the largest investigational device exemption (IDE) study ever conducted on hyaluronic acid dermal fillers¹

  • About 146 subjects in each study arm (439 total subjects in 3-arm trial)
  • Within-subject control, JUVÉDERM® injectable gel in one nasolabial fold (NLF) and ZYPLAST® dermal filler in the other
  • Primary end point: Improvement in NLF severity over the 6-month follow-up period
    • NLF severity was ranked on a 5-point scale
    • Assessed by a masked Independent Expert Reviewer through 24 weeks

JUVÉDERM® Ultra: A highly cross-linked formulation for versatility in contouring and volumizing facial wrinkles and folds.

88% of subjects maintained at least 1 grade improvement at 6 months

JUVÉDERM® Ultra Plus: A robust formulation for volumizing and correcting deeper folds and wrinkles.

94% of subjects rated as severe at baseline maintained at least 1 grade improvement at 6 months

Patient Preference

  • Patients overwhelmingly preferred Juvéderm® products over study control
     
    • 78%-88% of patients preferred Juvéderm® injectable gel at 6 months post-treatment
       

Safety Profile

  • Frequency and severity of treatment site responses were similar to control.
     
  • The smooth, uniform consistency of Juvéderm® allows it to flow easily and consistently into the skin. Click here to learn more about administering Juvéderm® injectable gel.
     
  • Studies with Juvéderm® showed no increased risk of hyperpigmentation or hypertrophic scarring in patients of color.
     

Materials for Healthcare Professionals and Patients

Juvéderm® Ultra Directions for Use

Juvéderm® Ultra Plus Directions for Use

Juvéderm® Ultra Patient Safety Information

Juvéderm® Ultra Plus Patient Safety Information

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Juvéderm® injectable gel is available...

... in two formulations to treat moderate to severe wrinkles and folds, allowing you to tailor treatment to your patients' facial aesthetic needs.

Learn More.

References

¹ Juvéderm® Ultra and Juvéderm® Ultra Plus Package Inserts

² Data on file, Allergan, Inc.

Important JUVÉDERM® Treatment Considerations

Juvéderm® Ultra and Juvéderm® Ultra Plus are indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Side effects were usually mild to moderate lasting 7 days or less and included temporary injection site reactions like redness, pain, firmness, swelling and bumps. For more information, please click on the “About Safety” link, or call the Allergan Product Support line at 1-877-345-5372.

BOTOX® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18-65.

Important Safety Information about BOTOX® Cosmetic

Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other reactions, such as difficulty swallowing, speaking or breathing, call your doctor immediately. The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness and/or bleeding/bruising may be associated with the injection. Patients with certain neuromuscular disorders such as ALS, myasthenia gravis or Lambert-Eaton syndrome may be at increased risk of serious side effects.

Click here for full BOTOX® Cosmetic prescribing information