Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine

Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.

Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.

Inclusion Criteria:

• Be male or female, 18 years of age or older
• Desire correction of moderate to severe nasolabial folds (NLFs)
• Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score

Exclusion Criteria:

• Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.
• Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or are planning to begin use of such products during the study.
• Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.
• Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.
• Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study.
• Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area