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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-27

Study Completion Date

2012-01-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Skin Wrinkling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Emervel Deep Lidocaine

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

Group Type EXPERIMENTAL

Emervel Deep Lidocaine

Intervention Type DEVICE

20 mg/mL + 0.3% lidocaine

Juvederm Ultra Plus

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

Group Type ACTIVE_COMPARATOR

Juvederm Ultra Plus

Intervention Type DEVICE

24mg/mL

Interventions

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Emervel Deep Lidocaine

20 mg/mL + 0.3% lidocaine

Intervention Type DEVICE

Juvederm Ultra Plus

24mg/mL

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No