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

Not Applicable

Completed

• Conditions: Chin Augmentation; Chin Retrusion
• Interventions: Device: Restylane Lyft with Lidocaine; Device: Juvederm Voluma XC

• Registration Number: NCT05777759
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-21
• Study Start: 2023-03-22
• Primary Completion: 2023-11-11
• Disposition First Posted: 2023-12-05
• Disposition First Submitted: 2024-04-30
• Study Completion: 2024-07-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Dermal Filler for indication: Restylane Lyft with Lidocaine	Restylane Lyft with Lidocaine	hyaluronic acid dermal filler
Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC	Juvederm Voluma XC	hyaluronic acid dermal filler

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Objective	3 months after last treatment	Change from Baseline in the Blinded Evaluators' live assessment using the GCRS (Galderma Chin Retrusion Scale).

Secondary Outcome Measures

Name	Time	Method
Secondary Effectiveness Objective	6, 9, and 12 months after last treatment.	Responder rate based on the Blinded Evaluator's live assessment using the GCRS (Galderma Chin Retrusion Scale) at 6, 9, and 12 months after last treatment.

Trial Locations

Locations (2)

United States, California; 🇺🇸 Manhattan Beach, California, United States

Galderma Research Site; 🇵🇷 San Juan, Puerto Rico