Contour
Conditions
Keywords
Lower Face Contouring
Brief summary
This study has been designed to evaluate the safety and effectiveness of sequential treatment with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline.
Detailed description
Participants may be treated with up to 6 treatments with Belkyra, followed by treatment with Voluma. Participants will have opportunity to participation in a skin biopsy sub-study.
Interventions
DRUGBELKYRA®
BELKYRA® was injected into preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart).
DEVICEJuvéderm® VOLUMA™ with Lidocaine
Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Grade 2 or above on Allergan Loss of Jawline Definition Scale (ALJDS) * Grade 2 or 3 on reported Clinician-Rated Submental Fat Rating Scale (CR-SMFRS) * Stable body weight for at least 26 weeks * Accept the obligation to forego any treatment or behavior (e.g., unshaven facial hair; significant changes to dietary or exercise habits) during the participants participation in the study that may affect the assessments of the submental area
Exclusion criteria
* Grade 4 on Submental Skin Laxity Grade (SMSLG) * Grade 4 on Allergan Jowl Fat Rating Scale (AJFRS) * Body mass index (BMI) \>35 kg/m\^2 * History of, or current symptoms of dysphagia * History of temporary, semi-permanent or permanent facial or neck dermal filler injections below the medial canthi at any time prior to treatment, or within 52 weeks before Screening for treatment above the medial canthi * History of facial and/or neck plastic surgery, tissue grafting or permanent facial implants anywhere in the face or neck * History of any intervention (e.g., liposuction, surgery, or lipolytic agents) to treat submental fat (SMF) * Evidence of any cause of enlargement in the submental area other than localized SMF * History of mesotherapy or ablative procedures to the face and/or neck 52 weeks before Screening * History of skin resurfacing in the neck or submental area within 26 weeks before Screening * Treatment with botulinum toxin injections in the neck or submental area within 26 weeks before Screening * Participants on prescription topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 26 weeks before Screening and who are unable to maintain regimen for the study * Systemic retinoid therapy within 52 weeks before Screening * Current use of oral corticosteroids * Is on a regimen of anticoagulation therapy (eg, warfarin, clopidogrel) * Has current injection site inflammatory or infectious processes, abscess, an unhealed wound, or a known cancerous or precancerous lesion in chin, masseter, or submental region * Planned oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 2 weeks prior to and after VOLUMA™ treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator | Baseline (Day 0) to Week 58 | The ALJDS was an investigator assessment of loss of jawline definition measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. Data is reported for both sides of the face, right side of the face and left side of the face. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score | Baseline (Day 0) to Week 58 | The participant assessed satisfaction using the 5 items on the Satisfaction of Lower Face and Jawline module of the FACE-Q™ questionnaire, measured on a 4-point scale where: 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied. The Rasch transformed scale total score was 0 (worst) to 100 (best). A positive change from baseline indicated improvement. |
| Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck | Baseline (Day 0) to Week 58 | The participant assessed satisfaction using the 10 items on the Appraisal of Neck module of the FACE-Q™ questionnaire measured on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, 4=extremely. The Rasch transformed scale total score was 0 (worst) to 100 (best). A positive change from baseline indicated improvement. |
| Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin | Baseline (Day 0) to Week 58 | The participant assessed satisfaction using the 5 items on the Appraisal of Area Under Chin module of the FACE-Q™ questionnaire measured on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, 4=extremely. The Rasch transformed scale total score was 0 (worst) to 100 (best). A negative change from baseline indicated worsening. |
| Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Baseline (Day 0) to Last Treatment (Up to Week 48) | The ALJDS was an investigator and independent reviewer assessment of jawline contour measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. A negative change from baseline indicated improvement. The data is reported for both sides of the face, right side of the face and left side of the face. |
| Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline (Day 0) to Week 58 | The PR-SMFRS was based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale where: 0=no chin fat at all, 1=a slight amount of chin fat, 2=a moderate amount of chin fat, 3=a large amount of chin fat, and 4=a very large amount of chin fat. A negative change from baseline indicated improvement. |
| Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score | Baseline (Day 0) to Week 58 | The SMSLG scale integrated 3 skin features: skin wrinkling, adherence to underlying neck structures (bone and muscle), and redundancy (horizontal and vertical folds) assessed by the investigator using a 4-point scale where: 1=none, 2=mild, 3=moderate and 4=severe. A negative change from baseline indicated improvement. |
| Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images | Baseline (Day 0) to Week 58 | The independent reviewer used photographic images collected at the time of the participant's live visit and the ALJDS to assess of loss of jawline definition using a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. A negative change from baseline indicates improvement. |
| Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline (Day 0) to Week 58 | The CR-SMFRS score was based on the investigator's clinical evaluation of the participant, where submental fullness was scored on a 5-point scale where: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme. A negative change from baseline indicated improvement. |
Countries
Australia
Participant flow
Recruitment details
Participants participated in the study at 3 study sites in Australia from 02 February 2018 to 05 December 2019.
Participants by arm
| Arm | Count |
|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Did not Meet all Eligibility Criteria Defined in the Protocol | 5 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrew Consent | 6 |
Baseline characteristics
| Characteristic | BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine |
|---|---|
| Age, Continuous | 48.0 years STANDARD_DEVIATION 11.07 |
| Race/Ethnicity, Customized Race Asian /Oriental | 1 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 51 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 53 / 53 |
| serious Total, serious adverse events | 2 / 53 |
Outcome results
Primary
Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator
The ALJDS was an investigator assessment of loss of jawline definition measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. Data is reported for both sides of the face, right side of the face and left side of the face.
Time frame: Baseline (Day 0) to Week 58
Population: Evaluable Set (ES) included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator | Both Sides of the Face | 92.9 percentage of participants |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator | Right Side of the Face | 92.9 percentage of participants |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator | Left Side of the Face | 92.9 percentage of participants |
Secondary
Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The CR-SMFRS score was based on the investigator's clinical evaluation of the participant, where submental fullness was scored on a 5-point scale where: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme. A negative change from baseline indicated improvement.
Time frame: Baseline (Day 0) to Week 58
Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline | 2.5 score on a scale | Standard Deviation 0.5 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Change From Baseline to Week 58 | -1.9 score on a scale | Standard Deviation 0.67 |
p-value: <0.001Paired t-test
Secondary
Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin
The participant assessed satisfaction using the 5 items on the Appraisal of Area Under Chin module of the FACE-Q™ questionnaire measured on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, 4=extremely. The Rasch transformed scale total score was 0 (worst) to 100 (best). A negative change from baseline indicated worsening.
Time frame: Baseline (Day 0) to Week 58
Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin | Baseline | 60.1 score on a scale | Standard Deviation 23.86 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin | Change From Baseline to Week 58 | -45.4 score on a scale | Standard Deviation 17.09 |
p-value: <0.001Paired t-test
Secondary
Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The PR-SMFRS was based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale where: 0=no chin fat at all, 1=a slight amount of chin fat, 2=a moderate amount of chin fat, 3=a large amount of chin fat, and 4=a very large amount of chin fat. A negative change from baseline indicated improvement.
Time frame: Baseline (Day 0) to Week 58
Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline | 2.3 score on a scale | Standard Deviation 0.71 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Change From Baseline to Week 58 | -1.6 score on a scale | Standard Deviation 0.61 |
p-value: <0.001Paired t-test
Secondary
Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score
The SMSLG scale integrated 3 skin features: skin wrinkling, adherence to underlying neck structures (bone and muscle), and redundancy (horizontal and vertical folds) assessed by the investigator using a 4-point scale where: 1=none, 2=mild, 3=moderate and 4=severe. A negative change from baseline indicated improvement.
Time frame: Baseline (Day 0) to Week 58
Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score | Baseline | 2.0 score on a scale | Standard Deviation 0.62 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score | Change From Baseline to Week 58 | -0.3 score on a scale | Standard Deviation 0.62 |
p-value: 0.003Paired t-test
Secondary
Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
The independent reviewer used photographic images collected at the time of the participant's live visit and the ALJDS to assess of loss of jawline definition using a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. A negative change from baseline indicates improvement.
Time frame: Baseline (Day 0) to Week 58
Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images | Both Side of the Face, Baseline | 2.9 score on a scale | Standard Deviation 1.05 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images | Both Side of the Face, End of Study | -0.7 score on a scale | Standard Deviation 0.91 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images | Right Side of the Face, Baseline | 2.7 score on a scale | Standard Deviation 1.12 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images | Right Side of the Face, End of study | -0.5 score on a scale | Standard Deviation 0.98 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images | Left Side of the Face, Baseline | 2.8 score on a scale | Standard Deviation 1.08 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images | Left Side of the Face, End of Study | -0.9 score on a scale | Standard Deviation 0.98 |
Comparison: Both Side of the Face, End of Studyp-value: <0.001Paired t-test
Comparison: Right Side of the Face, End of studyp-value: <0.001Paired t-test
Comparison: Left Side of the Face, End of Studyp-value: <0.001Paired t-test
Secondary
Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck
The participant assessed satisfaction using the 10 items on the Appraisal of Neck module of the FACE-Q™ questionnaire measured on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, 4=extremely. The Rasch transformed scale total score was 0 (worst) to 100 (best). A positive change from baseline indicated improvement.
Time frame: Baseline (Day 0) to Week 58
Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit. Overall number analyzed is the number of participants with available data at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck | Baseline | 13.8 score on a scale | Standard Deviation 8.85 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck | Change From Baseline to Week 58 | -11.0 score on a scale | Standard Deviation 13.44 |
p-value: 0.597Paired t-test
Secondary
Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score
The participant assessed satisfaction using the 5 items on the Satisfaction of Lower Face and Jawline module of the FACE-Q™ questionnaire, measured on a 4-point scale where: 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied. The Rasch transformed scale total score was 0 (worst) to 100 (best). A positive change from baseline indicated improvement.
Time frame: Baseline (Day 0) to Week 58
Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score | Baseline | 24.1 score on a score | Standard Deviation 16.78 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score | Change From Baseline to Week 58 | 55.9 score on a score | Standard Deviation 21.78 |
p-value: <0.001Paired t-test
Secondary
Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
The ALJDS was an investigator and independent reviewer assessment of jawline contour measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. A negative change from baseline indicated improvement. The data is reported for both sides of the face, right side of the face and left side of the face.
Time frame: Baseline (Day 0) to Last Treatment (Up to Week 48)
Population: FAS included all participants who received BELKYRA®. Number analyzed is the number of participants with available data at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Investigator: Both Sides of Face, Baseline | 2.7 score on a scale | Standard Deviation 0.52 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Investigator: Both Sides of Face, Last Treatment | -0.6 score on a scale | Standard Deviation 0.71 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Investigator: Right Side of Face, Baseline | 2.5 score on a scale | Standard Deviation 0.5 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Investigator: Right Side of Face, Last Treatment | -0.6 score on a scale | Standard Deviation 0.62 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Investigator: Left Side of Face, Baseline | 2.6 score on a scale | Standard Deviation 0.52 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Investigator: Left Side of Face, Last Treatment | -0.6 score on a scale | Standard Deviation 0.72 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Independent Reviewer: Both Sides of Face, Baseline | 2.9 score on a scale | Standard Deviation 1.04 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Independent Reviewer: Both Sides of Face, Last Treatment | -0.3 score on a scale | Standard Deviation 0.98 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Independent Reviewer: Right Side of Face, Baseline | 2.7 score on a scale | Standard Deviation 1.1 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Independent Reviewer: Right Side of Face, Last Treatment | -0.1 score on a scale | Standard Deviation 1.13 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Independent Reviewer: Left Side of Face, Baseline | 2.7 score on a scale | Standard Deviation 1.03 |
| BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine | Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS | Independent Reviewer: Left Side of Face, Last Treatment | -0.4 score on a scale | Standard Deviation 1.01 |
Comparison: Investigator: Both Sides of Face, Last Treatmentp-value: <0.001Paired t-test
Comparison: Investigator: Right Side of Face, Last Treatmentp-value: <0.001Paired t-test
Comparison: Investigator: Left Side of Face, Last Treatmentp-value: <0.001Paired t-test
Comparison: Independent Reviewer: Both Sides of Face, Last Treatmentp-value: 0.018Paired t-test
Comparison: Independent Reviewer: Right Side of Face, Last Treatmentp-value: 0.301Paired t-test
Comparison: Independent Reviewer: Left Side of Face, Last Treatmentp-value: 0.011Paired t-test