Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-07-08

Brief Summary

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The primary objective of the study is to demonstrate non-inferiority of Restylane Lyft with Lidocaine versus a comparator-control for augmentation of the chin region to improve the chin profile.

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Detailed Description

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Conditions

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Chin Augmentation Chin Retrusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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New Dermal Filler for indication: Restylane Lyft with Lidocaine

hyaluronic acid dermal filler

Group Type EXPERIMENTAL

Restylane Lyft with Lidocaine

Intervention Type DEVICE

hyaluronic acid

Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC

hyaluronic acid dermal filler

Group Type ACTIVE_COMPARATOR

Juvederm Voluma XC

Intervention Type DEVICE

hyaluronic acid

Interventions

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Restylane Lyft with Lidocaine

hyaluronic acid

Intervention Type DEVICE

Juvederm Voluma XC

hyaluronic acid

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Males or non-pregnant, non-breastfeeding females, 22 years of age or older
* Intent to receive treatment for augmentation and correction of retrusion in the chin region.

Exclusion Criteria

* Known/previous allergy of hypersensitivity to any injectable hyaluronic acid (HA) gel or gram-positive bacterial proteins.
* Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics.
* Previous or present multiple severe allergies or severe allergies, such as manifested by anaphylaxis or angioedema or family history of angioedema.
* Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the subnasale.
* Any previous aesthetic procedures or implants
* Presence of any disease or lesion near or on the area to be treated.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes