Status:
COMPLETED
Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds
Lead Sponsor:
Galderma R&D
Conditions:
Skin Wrinkling
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
This was a 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 facia...
Eligibility Criteria
Inclusion
- 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
Exclusion
- The subject had active skin disease or inflammation on or near a nasolabial fold that, in the principal investigator's opinion, would interfere with the study device injections and/or study assessments.
- The subject had a history of sensitivity to hyaluronic acid
- The subject had a history of sensitivity to lidocaine or other amide type anesthetics
- The subject was, in the principal investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.
Key Trial Info
Start Date :
September 27 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2012
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01205061
Start Date
September 27 2010
End Date
January 12 2012
Last Update
October 23 2023
Active Locations (11)
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1
Galderma research site
Los Angeles, California, United States, 90036
2
Galderma research site
San Francisco, California, United States, 94115
3
Galderma research site
New Haven, Connecticut, United States, 06511
4
Galderma research site
Miami Beach, Florida, United States, 33140