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

A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile

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

Study Overview

• Status: Completed
• Conditions: Chin Retrusion; Chin Augmentation
• Intervention / Treatment: Device: Restylane Lyft with Lidocaine; Device: Juvederm Voluma XC

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Galderma Research Site
• United States
  • California
    • Los Angeles, California, United States, 90025
      • Galderma Research Site
    • Manhattan Beach, California, United States, 90266
      • United States, California
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Galderma Research Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Galderma Research Site
    • Coral Gables, Florida, United States, 33143
      • Galderma Research Site
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Galderma Research Site
    • Atlanta, Georgia, United States, 30331
      • Galderma Research Site
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Galderma Research Site
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Galderma Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Galderma Research Site
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Galderma Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Dermal Filler for indication: Restylane Lyft with Lidocaine; hyaluronic acid dermal filler	Device: Restylane Lyft with Lidocaine; hyaluronic acid
Active Comparator: Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC; hyaluronic acid dermal filler	Device: Juvederm Voluma XC; hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Blinded Evaluators' Live Assessment Using the Galderma Chin Retrusion Scale (GCRS) at Month 3	GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Least squares (LS) mean, and 95 percent (%) confidence interval (CI) were obtained from a general linear mixed random intercept model with treatment group and baseline Galderma Chin Retrusion Scale score as fixed factors.	Baseline (last non-missing observation prior to the first administration of study product) and Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate Based on the Blinded Evaluator's Live Assessment Using the GCRS at Months 6, 9, and 12	GCRS is a validated 4-grade scale to assess the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Higher scores indicated more severity. Responder rate was defined as percentage of participants with an improvement of at least one grade on the GCRS from baseline. 95% CI was calculated using Clopper-Pearson method.	At Months 6, 9, and 12

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Study Director, Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): November 11, 2023
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: 43USCH2208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes