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

NCT07566286 | Not Yet Recruiting FDA Device

• 1 other identifier: 05DF2506
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Chin Augmentation

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Dermal Filler for Indication: Restylane Lyft with Lidocaine

EXPERIMENTAL

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

Interventions

Restylane Lyft with Lidocaine DEVICE

Sterile gel of hyaluronic acid.

Dermal Filler for Indication: Restylane Lyft with Lidocaine

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
• Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
• Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
• Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from subnasale.
• Any previous aesthetic procedures or implants.
• Presence of any disease or lesions near or on the area to be treated.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (8)

Galderma Investigational Site # 8680

Westport, Connecticut, 06880, United States

Location

Galderma Investigational Site # 8774

Boynton Beach, Florida, 33437, United States

Location

Galderma Investigational Site # 7030

Coral Gables, Florida, 33134, United States

Location

Galderma Investigational Site # 8682

Coral Gables, Florida, 33134, United States

Location

Galderma Investigational Site # 7042

Atlanta, Georgia, 30331, United States

Location

Galderma Investigational Site # 7043

Bethesda, Maryland, 20852, United States

Location

Galderma Investigational Site # 7118

Nashville, Tennessee, 37203, United States

Location

Galderma Investigational Site # 8662

Spring, Texas, 77388, United States

Location

Central Study Contacts

Clinical Project Manager

CONTACT

817-961-5000; clinical.studies@galderma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)