Jawline Definition
Conditions
Brief summary
This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition
Interventions
DEVICEVOLUX XC
Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.
OTHERNo-treatment control
No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Has Moderate or Severe loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3 * Treating Investigator (TI) considers the subject's jaw amenable to an improvement of at least 1 grade on the scale for the jawline definition * Written Informed Consent (IC) has been obtained
Exclusion criteria
* Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study * Has ever undergone fat injections in the malar, chin or jawline area or is planning to undergo this procedure during the study * Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) below the subnasale within 36 months before enrollment or is planning to undergo such treatment during the study * Has received deoxycholic acid treatment in the submental region in the last 6 months * Has active autoimmune disease * Females who are pregnant, nursing, or planning a pregnancy during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS) | Month 6 | The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Note Improved or Much Improved in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | Month 6 | The Evaluating Investigator (EI) will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported. |
| Percentage of Participants Who Note Improved or Much Improved in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS) | Month 6 | The participant will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported. |
| Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score | Baseline to Month 6 | The subject will assess satisfaction using the 5 questions on the Satisfaction of Lower Face and Jawline scale of the FACE-Q™ questionnaire measured on a 4-point scale (1=Very Dissatisfied 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied). The raw scale summed score will then be converted into a Rasch-transformed score from 0 (worst) to 100 (best) |
Countries
United States
Participant flow
Recruitment details
Study consists of 2 groups: Treatment and Control. The treatment group rec'd treatment Day 1 and was followed up to Month 12. At Month 12 they had the option to exit the study or receive maintenance treatment with an add'l 3 months of follow-up after treatment. The control group followed a 6-month no-treatment control period after which they had the option to exit the study or proceed to the post-control period where they receive treatment with 12 months of follow-up after their last treatment.
Participants by arm
| Arm | Count |
|---|---|
| No-treatment Control No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.
No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. | 49 |
| VOLUX XC Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.
VOLUX XC: Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12. | 157 |
| Total | 206 |
Baseline characteristics
| Characteristic | Total | VOLUX XC | No-treatment Control |
|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 8.5 | 59.3 years STANDARD_DEVIATION 8.22 | 57.9 years STANDARD_DEVIATION 9.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 31 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 164 Participants | 126 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Participant Level Allergan Loss of Jawline Definition Scale (ALJDS) Extreme | 9 units on a scale | 9 units on a scale | 0 units on a scale |
| Participant Level Allergan Loss of Jawline Definition Scale (ALJDS) Moderate | 47 units on a scale | 34 units on a scale | 13 units on a scale |
| Participant Level Allergan Loss of Jawline Definition Scale (ALJDS) Severe | 150 units on a scale | 114 units on a scale | 36 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 21 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 174 Participants | 132 Participants | 42 Participants |
| Region of Enrollment United States | 206 participants | 157 participants | 49 participants |
| Sex: Female, Male Female | 180 Participants | 141 Participants | 39 Participants |
| Sex: Female, Male Male | 26 Participants | 16 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 156 | 0 / 42 | 0 / 87 |
| other Total, other adverse events | 0 / 50 | 9 / 156 | 5 / 42 | 1 / 87 |
| serious Total, serious adverse events | 1 / 50 | 17 / 156 | 3 / 42 | 4 / 87 |
Outcome results
Primary
Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)
The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)
Time frame: Month 6
Population: All modified intent-to-treat (mITT) participants who have Month 6 assessment on the ALJDS scale on both sides of the jaw. Multiple imputation was performed on participants with missing data for the Month 6 assessment on the ALJDS on both sides of jaw
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No-treatment Control | Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS) | 38.0 percentage of participants |
| VOLUX XC | Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS) | 69.0 percentage of participants |
p-value: 0.000195% CI: [15.33, 46.54]Multiple Imputation
Secondary
Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score
The subject will assess satisfaction using the 5 questions on the Satisfaction of Lower Face and Jawline scale of the FACE-Q™ questionnaire measured on a 4-point scale (1=Very Dissatisfied 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied). The raw scale summed score will then be converted into a Rasch-transformed score from 0 (worst) to 100 (best)
Time frame: Baseline to Month 6
Population: As per the Protocol and the Statistical Analysis Plan: During the Control Period these data were collected only for participants that were randomized and received VOLUX treatment at the beginning of the Control Period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No-treatment Control | Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score | 45.9 score on a scale | Standard Deviation 33.09 |
p-value: <0.000195% CI: [40.45, 51.28]Paired T-test
Secondary
Percentage of Participants Who Note Improved or Much Improved in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
The Evaluating Investigator (EI) will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.
Time frame: Month 6
Population: Modified intent-to-treat (mITT) Population included all randomized participants with non-missing baseline on the ALJDS scale on both sides of the jaw
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No-treatment Control | Percentage of Participants Who Note Improved or Much Improved in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | 13 Participants |
| VOLUX XC | Percentage of Participants Who Note Improved or Much Improved in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | 130 Participants |
Secondary
Percentage of Participants Who Note Improved or Much Improved in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
The participant will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.
Time frame: Month 6
Population: As per the Protocol and the Statistical Analysis Plan: During the Control Period these data were collected only for participants that were randomized and received VOLUX treatment at the beginning of the Control Period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No-treatment Control | Percentage of Participants Who Note Improved or Much Improved in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS) | 129 Participants |