Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds

Inclusion criteria

• Desires correction of moderate to severe nasolabial folds (NLFs)
• Both NLFs have the same pre-treatment NLF severity score (either moderate or severe)
• Females of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study

Exclusion criteria

• Cosmetic facial procedures [e.g., facelift, resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, BOTOX Cosmetic injections, or mesotherapy] in the lower 2/3 of the face, including the neck, within 1 month prior to study entry or be planning to undergo any of these procedures at any time during the study
• Initiating 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 during the study
• Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment is within 5mL of the recommended annual maximum volume for HA dermal fillers
• Previous injection of semi-permanent fillers or placement of facial implants anywhere in the head and neck or implantation of any of these products during the study
• Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal protein
• Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region
• Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections