Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds

Completed · Not applicable

Conditions studied: Skin Wrinkling

In brief

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.

Key facts

Study ID

NCT01205061

Run by

Galderma R&D

People needed

162

Starts

2010-09-27

Expected to finish

2012-01-12

Last updated by the study team

2023-10-23

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Galderma research site — Los Angeles, California, United States
• Galderma research site — San Francisco, California, United States
• Galderma research site — New Haven, Connecticut, United States
• Galderma research site — Miami Beach, Florida, United States
• Galderma research site — Snellville, Georgia, United States
• Galderma research site — Hunt Valley, Maryland, United States
• Galderma research site — Warren, Michigan, United States
• Galderma research site — White Plains, New York, United States
• Galderma research site — Charlotte, North Carolina, United States
• Galderma research site — Nashville, Tennessee, United States
• Galderma research site — Plano, Texas, United States

Full record on ClinicalTrials.gov

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