CompletedInterventionalNot ApplicableUpdated Aug 26, 2022
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds | NCT00850889 | Trialant
CompletedInterventionalPhase 4Updated Jan 9, 2019
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
ClinicalTrials.gov ID
NCT00850889
Lead Sponsor
Allergan MedicalINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
32Actual
Last Update Posted
Jan 9, 2019Actual
Start Date
Nov 2008
Primary Completion Date
Nov 2008Actual
Completion Date
Nov 2008Actual
Brief Summary
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
Nasolabial Folds
Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine
A gel of hyaluronic acid (concentration of 20 mg/mL)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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