Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region

A Prospective, Multicenter Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile

The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Chin Augmentation
• Intervention / Treatment: Device: Restylane Lyft with Lidocaine

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Project Manager; Phone Number: +1 817-961-5000; Email: clinical.studies@galderma.com

Study Locations

• United States
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Galderma Investigational Site # 8680
      • Contact: Galderma Project Manager
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Galderma Investigational Site # 8774
      • Contact: Galderma Project Manager
    • Coral Gables, Florida, United States, 33134
      • Galderma Investigational Site # 7030
      • Contact: Galderma Project Manager
    • Coral Gables, Florida, United States, 33134
      • Galderma Investigational Site # 8682
      • Contact: Galderma Project Manager
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Galderma Investigational Site # 7042
      • Contact: Galderma Project Manager
  • Maryland
    • Bethesda, Maryland, United States, 20852
      • Galderma Investigational Site # 7043
      • Contact: Galderma Project Manager
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Galderma Investigational Site # 7118
  • Texas
    • Spring, Texas, United States, 77388
      • Galderma Investigational Site # 8662
      • Contact: Galderma Project Manager

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermal Filler for Indication: Restylane Lyft with Lidocaine; Participants will receive initial treatment with Restylane Lyft with Lidocaine in the chin region at Baseline with an optional touch-up treatment at 1 month after initial treatment and an optional retreatment 12 months after the last treatment.	Device: Restylane Lyft with Lidocaine; Sterile gel of hyaluronic acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment	An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational product (IP). TEAEs that are related to the device and/or injection procedure after the Month 12 optional retreatment will be reported.	From Month 12 up to 3 months after optional retreatment (i.e. Month 15)

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 05DF2506

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