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Completed

NCT Number: NCT05622812

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

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Key information

Conditions

Jawline Definition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Research Site, Vancouver, British Columbia, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Restylane Lyft Lidocaine

Device

Treatment for Jawline definition

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 21, 2022
Registry last updated
Mar 7, 2025

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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