Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds

Completed · Not applicable

Conditions studied: Skin Wrinkling

In brief

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.

Key facts

Study ID

NCT01205048

Run by

Galderma R&D

People needed

171

Starts

2010-09-01

Expected to finish

2012-01-19

Last updated by the study team

2023-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Total Skin and Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• Skin Care & Laser Physicians of Beverly Hills — Los Angeles, California, United States
• FacesPlus Aesthetic Facility — San Diego, California, United States
• Therapeutics Research — San Diego, California, United States
• Steven Fagien — Boca Raton, Florida, United States
• Dermatology Research Institute — Coral Gables, Florida, United States
• Laser & Skin Surgery Center in Indiana — Carmel, Indiana, United States
• Callender Center for Clinical Research — Glendale, Maryland, United States
• The Center for Dermatology, Cosmetic & Laser Surgery — Mount Kisco, New York, United States
• Sadick Research Group — New York, New York, United States
• Oregon Medical Research PC — Portland, Oregon, United States
• DermResearch — Austin, Texas, United States

Full record on ClinicalTrials.gov

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