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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07566286
Enrollment
100
Registered
2026-05-05
Start date
2026-06-03
Completion date
2028-02-28
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chin Augmentation

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.

Interventions

Sterile gel of hyaluronic acid.

Sponsors

Galderma R&D
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional RetreatmentFrom Month 12 up to 3 months after optional retreatment (i.e. Month 15)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.

Countries

United States

Contacts

CONTACTClinical Project Manager
clinical.studies@galderma.com817-961-5000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026