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

Galderma

Status: Completed

Conditions: Skin Wrinkling

Treatments: Device: Juvederm Ultra Plus; Device: Emervel Deep Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01205061

RD.06.CIP.18159

Details and patient eligibility

About

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.

Full 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 facial wrinkles and folds. Two physicians, an Unblinded Injecting Investigator and a Blinded Evaluating Investigator, were required at each study center. The Unblinded Injecting Investigator was different from the Blinded Evaluating Investigator.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 2 patient groups

Emervel Deep Lidocaine

Experimental group

Description:

NLFs (Nasolabial Folds) were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).

Treatment:

Device: Emervel Deep Lidocaine

Juvederm Ultra Plus

Active Comparator group

Description:

NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).

Treatment:

Device: Juvederm Ultra Plus