Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

Galderma

Status: Completed

Conditions: Cheek Augmentation; Midface Contour Deficiencies

Treatments: Device: Restylane Lyft with Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03160716

43USC1633

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Treatment

Other group

Treatment:

Device: Restylane Lyft with Lidocaine