A Pivotal USA Randomized, Evaluator-blinded, Active-controlled, Multi-center, Split-face Comparison Study of Emervel® Deep Lidocaine Versus Juvederm® Ultra Plus in the Treatment of Moderate to Severe Facial Wrinkles and Folds
Status: Completed
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of the study was to compare the effectiveness and safety of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• The subject was a male or female 18 years of age or older
• The subject had bilateral nasolabial folds that, in the opinion of both the blinded evaluating investigator and the unblinded injecting investigator, was corrected with an injectable dermal implant
• The subject had the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold
Locations
United States
California
Galderma research site
Los Angeles
Galderma research site
San Francisco
Connecticut
Galderma research site
New Haven
Florida
Galderma research site
Miami Beach
Georgia
Galderma research site
Snellville
Maryland
Galderma research site
Hunt Valley
Michigan
Galderma research site
Warren
North Carolina
Galderma research site
Charlotte
New York
Galderma research site
White Plains
Tennessee
Galderma research site
Nashville
Texas
Galderma research site
Plano
Time Frame
Start Date: 2010-09-27
Completion Date: 2012-01-12
Participants
Target number of participants: 162
Treatments
Experimental: Emervel Deep Lidocaine
NLFs (Nasolabial Folds) were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).
Active_comparator: Juvederm Ultra Plus
NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).
Authors
Jeffrey Adelglass, Pearl Grimes, Robert Weiss, Steven Grekin, Michael Gold, Corey Maas, Lisa Donofrio, Leslie Baumann, Jonathan Weiss, Rhoda Narins
Sponsors
Leads: Galderma R&D