Status:
COMPLETED
Emervel Classic Lidocaine Versus Juvederm® Ultra 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 this study is to compare the effectiveness and safety of Emervel Classic Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and folds.
Eligibility Criteria
Inclusion
- The subject is a male or female 18 years of age or older
- The subject has bilateral nasolabial folds that, in the opinion of both the Blinded Evaluating Investigator and the Unblinded Injecting Investigator, can be corrected with an injectable dermal implant
- The subject has the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold
Exclusion
- The subject has 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 has a history of sensitivity to hyaluronic acid
- The subject has a history of sensitivity to lidocaine or other amide type anesthetics
- The subject is, 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 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2012
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01205048
Start Date
September 1 2010
End Date
January 19 2012
Last Update
July 25 2023
Active Locations (12)
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1
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States, 35202
2
Skin Care & Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
3
FacesPlus Aesthetic Facility
San Diego, California, United States, 92122
4
Therapeutics Research
San Diego, California, United States, 92123