Status:
COMPLETED
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
Lead Sponsor:
Allergan Medical
Conditions:
Nasolabial Folds
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00850889
Start Date
November 1 2008
End Date
November 1 2008
Last Update
January 9 2019
Active Locations (1)
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1
Niagara Falls, Ontario, Canada