Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

November 28, 2023 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

Active, not recruiting

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
Effectiveness of Restylane Lyft Lidocaine versus a no treatment control in jawline definition as measured by the Galderma Jawline Scale
Time Frame: 3 Months
Scale rating is 0-4, where higher score = more volume deficiency in the treatment area
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Restylane Lyft Lidocaine on the Galderma Jawline Scale
Time Frame: Baseline, 6, 9, and 12 Months
Scale rating is 0-4, where higher score = more volume deficiency in the treatment area
Baseline, 6, 9, and 12 Months
Evaluate the effectiveness of Restylane Lyft Lidocaine on the Global Aesthetic Improvement Scale (GAIS)
Time Frame: Baseline, 3, 6, 9, and 12 Months
Scale rating ranges from very much improved to very much worse appearance
Baseline, 3, 6, 9, and 12 Months
Evaluate the effectiveness of Restylane Lyft Lidocaine on Subject Satisfaction Questionnaire (SSQ)
Time Frame: 3, 6, 9, and 12 Months
Questionnaire rating ranges from very satisfied to very dissatisfied with aesthetic outcome and treatment
3, 6, 9, and 12 Months

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 (Estimated)

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)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

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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