Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-16

Study Completion Date

2024-06-14

Brief Summary

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This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition

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Detailed Description

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A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada

Conditions

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Jawline Definition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, randomized, evaluator-blinded, no treatment controlled, parallel group, multicenter phase IV study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for jawline definition.

A parallel study: two or more groups of participants receive different interventions. Trial participants are assigned to one of the treatment arms at the beginning of the trial and remain in that trial arm throughout the length of the trial. A randomized group is usually assigned.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments.

Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments. Safety assessments will be performed by non-blinded personnel.

Study Groups

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Treatment group

Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment

Group Type EXPERIMENTAL

Restylane Lyft Lidocaine

Intervention Type DEVICE

Treatment for Jawline definition

No-treatment control group

Optional treatment will be administered at 12 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Restylane Lyft Lidocaine

Treatment for Jawline definition

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and female adults willing to comply with the requirements of the study and providing a signed written informed consent
* Consent the use of facial images for marketing purposes and educational material
* Subject with moderate to very severe (Grade 2 to 4) on the GJS
* Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
* Female of childbearing potential with a negative urine pregnancy test before treatment

Exclusion Criteria

* Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
* Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
* Subject with bleeding disorders or taking thrombolytics or anticoagulants
* Prior surgical procedure in the treatment area
* History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
* Presence of any disease or lesions near or on the area to be treated
* Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol
* Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period
* Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company
* Participation in any other interventional clinical study within 30 days before treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes