Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition

Detailed Description
-----------------
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

Official Title
-----------------
A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

Conditions
-----------------
Jawline Definition

Intervention / Treatment
-----------------
* Device: Restylane Lyft Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment | Device: Restylane Lyft Lidocaine<br>* Treatment for Jawline definition<br>|
| No Intervention: No-treatment control group<br>Optional treatment will be administered at 12 months | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Restylane Lyft Lidocaine versus a no treatment control in jawline definition as measured by the Galderma Jawline Scale | Scale rating is 0-4, where higher score = more volume deficiency in the treatment area | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Restylane Lyft Lidocaine on the Galderma Jawline Scale | Scale rating is 0-4, where higher score = more volume deficiency in the treatment area | Baseline, 6, 9, and 12 Months | 
| Evaluate the effectiveness of Restylane Lyft Lidocaine on the Global Aesthetic Improvement Scale (GAIS) | Scale rating ranges from very much improved to very much worse appearance | Baseline, 3, 6, 9, and 12 Months | 
| Evaluate the effectiveness of Restylane Lyft Lidocaine on Subject Satisfaction Questionnaire (SSQ) | Questionnaire rating ranges from very satisfied to very dissatisfied with aesthetic outcome and treatment | 3, 6, 9, and 12 Months |