Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-16

Study Completion Date

2017-10-31

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.

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Detailed Description

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Conditions

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Cheek Augmentation Midface Contour Deficiencies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type OTHER

Restylane Lyft with Lidocaine

Intervention Type DEVICE

a sterile gel of hyaluronic acid (HA)

Interventions

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Restylane Lyft with Lidocaine

a sterile gel of hyaluronic acid (HA)

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes