Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

Study Overview
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Brief Summary
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This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.

Official Title
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A Multicenter, Open-Label, Prospective Study of Cannula Injection of Restylane Lyft With Lidocaine for Cheek Augmentation and the Correction of Age Related Midface Contour Deficiencies

Conditions
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Cheek Augmentation, Midface Contour Deficiencies

Intervention / Treatment
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* Device: Restylane Lyft with Lidocaine


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: Subjects willing to comply with the requirements of the study and providing a signed written informed consent. Males or non-pregnant, non-breastfeeding females, 22 years of age or older. Mild to Substantial Midface Volume Loss Primary Exclusion Criteria: Allergy or hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins Allergy or hypersensitivity to lidocaine or other amide-type anaesthetics, or topical anaesthetics or nerve blocking agents Undergone prior surgery to midface

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br> | Device: Restylane Lyft with Lidocaine<br>* a sterile gel of hyaluronic acid (HA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events [Safety] | To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Aesthetic Improvement | To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as Improved or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). | 16 weeks | 
| Number of Participants That Responded to Treatment | To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). | 16 weeks | 
| Subject Satisfaction | To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction. | 8 weeks |