Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

March 4, 2025 updated by: Galderma R&D

A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E1
        • Galderma Research Site
      • Vancouver, British Columbia, Canada, V6H4E1
        • Galderma Research Site
    • Ontario
      • Burlington, Ontario, Canada, L7N3N2
        • Galderma Research Site
      • London, Ontario, Canada, N6H5L5
        • Galderma Research Site
      • Oakville, Ontario, Canada, L6J7W5
        • Galderma Research Site
      • Toronto, Ontario, Canada, M5R3N8
        • Galderma Research Site
      • Windsor, Ontario, Canada, N8W5L7
        • Galderma Research Site
      • Woodbridge, Ontario, Canada, L4L8E2
        • Galderma Research Site
    • Quebec
      • Westmount, Quebec, Canada, H3Z1C3
        • Galderma Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female adults willing to comply with the requirements of the study and providing a signed written informed consent
  • Consent the use of facial images for marketing purposes and educational material
  • Subject with moderate to very severe (Grade 2 to 4) on the GJS
  • Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
  • Female of childbearing potential with a negative urine pregnancy test before treatment

Exclusion Criteria:

  • Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
  • Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
  • Subject with bleeding disorders or taking thrombolytics or anticoagulants
  • Prior surgical procedure in the treatment area
  • History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
  • Presence of any disease or lesions near or on the area to be treated
  • Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol
  • Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period
  • Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company
  • Participation in any other interventional clinical study within 30 days before treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment
Device: Restylane Lyft Lidocaine
Treatment for Jawline definition
No Intervention: No-treatment control group
Optional treatment will be administered at 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator
Time Frame: Baseline, Month 3
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Baseline, Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator
Time Frame: Baseline, Months 6, 9 and 12
The GJS is a validated 5-point scale for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. Here, higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Baseline, Months 6, 9 and 12
Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12
Time Frame: Baseline, Months 3, 6, 9 and 12
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the Treating Investigator was reported here.
Baseline, Months 3, 6, 9 and 12
Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12
Time Frame: Baseline, Months 3, 6, 9 and 12
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the participant was reported here.
Baseline, Months 3, 6, 9 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Study Director: Study Director, Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Actual)

October 16, 2023

Study Completion (Actual)

June 14, 2024

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05DF2209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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