Jawline Definition
Conditions
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
Interventions
DEVICERestylane Lyft Lidocaine
Treatment for Jawline definition
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments. Investigator blinding will be accomplished by having a Treating Investigator administer the treatments and having a Blinded Evaluator, to whom randomization and treatment are concealed, conduct blinded assessments. Safety assessments will be performed by non-blinded personnel.
Intervention model description
A prospective, randomized, evaluator-blinded, no treatment controlled, parallel group, multicenter phase IV study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for jawline definition. A parallel study: two or more groups of participants receive different interventions. Trial participants are assigned to one of the treatment arms at the beginning of the trial and remain in that trial arm throughout the length of the trial. A randomized group is usually assigned.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Participant flow
Recruitment details
The study was conducted at 9 sites in Canada from 16 February 2023 to 14 June 2024.
Pre-assignment details
A total of 150 participants were screened, of which 10 were screen failures. A total of 140 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Restylane Lyft Lidocaine Participants received Restylane Lyft Lidocaine injection at Day 1 and one optional touch-up treatment at 1 month after treatment. | 105 |
| No-treatment Control Group Participants remained untreated and were offered optional treatment at 12 months from Baseline (Day 1). | 35 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | No-treatment Control Group | Total | Restylane Lyft Lidocaine |
|---|---|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 11.13 | 54.7 years STANDARD_DEVIATION 10.89 | 55.2 years STANDARD_DEVIATION 10.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 135 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 126 Participants | 94 Participants |
| Sex: Female, Male Female | 32 Participants | 130 Participants | 98 Participants |
| Sex: Female, Male Male | 3 Participants | 10 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 35 |
| other Total, other adverse events | 39 / 105 | 12 / 35 |
| serious Total, serious adverse events | 2 / 105 | 1 / 35 |
Outcome results
Primary
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
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.
Time frame: Baseline, Month 3
Population: Analysis was performed on ITT population. The ITT population included all participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Lyft Lidocaine | 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 | 67.6 percentage of responders |
| No-treatment Control Group | 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 | 28.6 percentage of responders |
p-value: <0.00195% CI: [21.6, 56.5]Fisher's Exact Test.
Secondary
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
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.
Time frame: Baseline, Months 3, 6, 9 and 12
Population: Analysis was performed on the ITT population. The ITT population included all randomized participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Lyft Lidocaine | 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 | Month 3 | 93.1 percentage of participants |
| Restylane Lyft Lidocaine | 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 | Month 6 | 87.9 percentage of participants |
| Restylane Lyft Lidocaine | 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 | Month 9 | 80.4 percentage of participants |
| Restylane Lyft Lidocaine | 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 | Month 12 | 71.6 percentage of participants |
| No-treatment Control Group | 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 | Month 12 | 0.0 percentage of participants |
| No-treatment Control Group | 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 | Month 3 | 0.0 percentage of participants |
| No-treatment Control Group | 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 | Month 9 | 0.0 percentage of participants |
| No-treatment Control Group | 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 | Month 6 | 0.0 percentage of participants |
Comparison: Month 3p-value: <0.00195% CI: [88.2, 98]Fisher's Exact Test.
Comparison: Month 6p-value: <0.00195% CI: [81.4, 94.3]Fisher's Exact Test.
p-value: <0.00195% CI: [72.7, 88.1]Fisher's Exact Test.
Comparison: Month 12p-value: <0.00195% CI: [62.8, 80.3]Fisher's Exact Test.
Secondary
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
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.
Time frame: Baseline, Months 3, 6, 9 and 12
Population: Analysis was performed on the ITT population. The ITT population included all randomized participants. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Lyft Lidocaine | 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 | Month 3 | 99.0 percentage of participants |
| Restylane Lyft Lidocaine | 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 | Month 6 | 97.0 percentage of participants |
| Restylane Lyft Lidocaine | 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 | Month 9 | 90.2 percentage of participants |
| Restylane Lyft Lidocaine | 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 | Month 12 | 80.4 percentage of participants |
| No-treatment Control Group | 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 | Month 12 | 6.7 percentage of participants |
| No-treatment Control Group | 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 | Month 3 | 0.0 percentage of participants |
| No-treatment Control Group | 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 | Month 9 | 9.7 percentage of participants |
| No-treatment Control Group | 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 | Month 6 | 9.4 percentage of participants |
Comparison: Month 3p-value: <0.00195% CI: [97.1, 100]Fisher's Exact Test.
Comparison: Month 6p-value: <0.00195% CI: [76.9, 98.2]Fisher's Exact Test.
Comparison: Month 9p-value: <0.00195% CI: [68.6, 92.4]Fisher's Exact Test.
Comparison: Month 12p-value: <0.00195% CI: [61.9, 85.5]Fisher's Exact Test.
Secondary
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
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.
Time frame: Baseline, Months 6, 9 and 12
Population: Analysis was performed on ITT population. The ITT population included all participants who were randomized. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restylane Lyft Lidocaine | 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 | Month 6 | 62.2 percentage of responders |
| Restylane Lyft Lidocaine | 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 | Month 9 | 57.8 percentage of responders |
| Restylane Lyft Lidocaine | 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 | Month 12 | 49.5 percentage of responders |
| No-treatment Control Group | 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 | Month 6 | 21.9 percentage of responders |
| No-treatment Control Group | 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 | Month 9 | 16.1 percentage of responders |
| No-treatment Control Group | 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 | Month 12 | 19.4 percentage of responders |
Comparison: Month 6p-value: <0.00195% CI: [23.1, 57.6]Fisher's Exact Test.
Comparison: Month 9p-value: <0.00195% CI: [25.6, 57.8]Fisher's Exact Test.
Comparison: Month 12p-value: 0.00395% CI: [13.2, 47.1]Fisher's Exact Test.