Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition

Not Applicable

Completed

Conditions: Jawline Definition

Interventions: Device: Restylane Lyft Lidocaine

Registration Number: NCT05622812

Lead Sponsor: Galderma R&D

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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Restylane Lyft Lidocaine	Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.