NCT05777759

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

March 9, 2023

Last Update Submit

January 15, 2025

Conditions

Chin AugmentationChin Retrusion

Outcome Measures

Primary Outcomes (1)

  • Primary Effectiveness Objective

    Change from Baseline in the Blinded Evaluators' live assessment using the GCRS (Galderma Chin Retrusion Scale).

    3 months after last treatment

Secondary Outcomes (1)

  • Secondary Effectiveness Objective

    6, 9, and 12 months after last treatment.

Study Arms (2)

New Dermal Filler for indication: Restylane Lyft with Lidocaine

EXPERIMENTAL

hyaluronic acid dermal filler

Device: Restylane Lyft with Lidocaine

Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC

ACTIVE COMPARATOR

hyaluronic acid dermal filler

Device: Juvederm Voluma XC

Interventions

Restylane Lyft with LidocaineDEVICE

hyaluronic acid

New Dermal Filler for indication: Restylane Lyft with Lidocaine
Juvederm Voluma XCDEVICE

hyaluronic acid

Active Comparator: FDA approved Dermal Filler: Juvederm Voluma XC

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Galderma Research Site

Los Angeles, California, 90025, United States

Location

United States, California

Manhattan Beach, California, 90266, United States

Location

Galderma Research Site

Westport, Connecticut, 06880, United States

Location

Galderma Research Site

Aventura, Florida, 33180, United States

Location

Galderma Research Site

Coral Gables, Florida, 33143, United States

Location

Galderma Research Site

Alpharetta, Georgia, 30022, United States

Location

Galderma Research Site

Atlanta, Georgia, 30331, United States

Location

Galderma Research Site

Rockville, Maryland, 20852, United States

Location

Galderma Research Site

Chestnut Hill, Massachusetts, 02467, United States

Location

Galderma Research Site

Nashville, Tennessee, 37203, United States

Location

Galderma Research Site

Pflugerville, Texas, 78660, United States

Location

Galderma Research Site

San Juan, 00917, Puerto Rico

Location

Study Officials

  • Study Director

    Galderma R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

March 22, 2023

Primary Completion

November 11, 2023

Study Completion

July 8, 2024

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(11)PR(1)