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

Galderma

Status: Completed

Conditions: Chin Augmentation; Chin Retrusion

Treatments: Device: Restylane Lyft with Lidocaine; Device: Juvederm Voluma XC

Study type: Interventional

Funder types: Industry

Identifiers

NCT05777759

43USCH2208

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

New Dermal Filler for indication: Restylane Lyft with Lidocaine

Experimental group

Description:

hyaluronic acid dermal filler

Treatment:

Device: Restylane Lyft with Lidocaine

Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC

Active Comparator group

Description:

hyaluronic acid dermal filler

Treatment:

Device: Juvederm Voluma XC