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

Galderma

Status

Completed

Conditions

Skin Wrinkling

Treatments

Device: Emervel Classic Lidocaine

Device: Juvederm® Ultra

Study type

Interventional

Funder types

Industry

Identifiers

NCT01205048

RD.06.CIP.18156

Details and patient eligibility

About

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.

Enrollment

171 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.