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NCT Number: NCT07566286

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

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.

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Key information

Conditions

Chin Augmentation

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Investigational Site # 8680, Westport, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Restylane Lyft with Lidocaine

Device

Sterile gel of hyaluronic acid.

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

    Time frame: From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Project Manager

CONTACT

[email protected]

817-961-5000 ext. +1

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 5, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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