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

Sponsored by Galderma R&D

About this trial

Last updated 3 years ago

Study ID

RD.06.CIP.18159

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Ended 14 years ago

What is this trial 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.

What are the participation requirements?

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.