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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BELKYRA® | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) to Week 58 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) to Last Treatment (Up to Week 48) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Silberberg | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Darlinghurst Dermatology | Darlinghurst | New South Wales | 2010 | Australia | ||
| Living Art |
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Participants participated in the study at 3 study sites in Australia from 02 February 2018 to 05 December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
FAS included all participants who received BELKYRA®.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 0) to Week 58 |
|
Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Volvulus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2020 | Dec 4, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 21, 2018 | Dec 4, 2020 | Prot_001.pdf |
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| Juvéderm® VOLUMA™ with Lidocaine | Device | Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border. |
|
| 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. | Baseline (Day 0) to Week 58 |
| 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. | Baseline (Day 0) to Week 58 |
| 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. | Baseline (Day 0) to Week 58 |
| 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. | Baseline (Day 0) to Week 58 |
| 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. | Baseline (Day 0) to Week 58 |
| 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. | Baseline (Day 0) to Week 58 |
| 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. | Baseline (Day 0) to Week 58 |
| East Melbourne |
| Victoria |
| 3002 |
| Australia |
| Dermatology Institute of Victoria | South Yarra | Victoria | 3141 | Australia |
| Did not Meet all Eligibility Criteria Defined in the Protocol |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| 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. | FAS included all participants who received BELKYRA®. Number analyzed is the number of participants with available data at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) to Last Treatment (Up to Week 48) |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a score | Baseline (Day 0) to Week 58 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) to Week 58 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) to Week 58 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) to Week 58 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) to Week 58 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) to Week 58 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) to Week 58 |
|
|
|
|
| 0 |
| 53 |
| 2 |
| 53 |
| 53 |
| 53 |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site discolouration | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site hypoaesthesia | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site mass | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site warmth | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
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| Investigator: Right Side of Face, Baseline |
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| Investigator: Right Side of Face, Last Treatment |
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| Investigator: Left Side of Face, Baseline |
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| Investigator: Left Side of Face, Last Treatment |
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| Independent Reviewer: Both Sides of Face, Baseline |
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| Independent Reviewer: Both Sides of Face, Last Treatment |
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| Independent Reviewer: Right Side of Face, Baseline |
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| Independent Reviewer: Right Side of Face, Last Treatment |
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| Independent Reviewer: Left Side of Face, Baseline |
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| Independent Reviewer: Left Side of Face, Last Treatment |
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| Paired t-test |
| <0.001 |
P-value was based on paired t-test for the mean difference. |
| Other |
| Investigator: Left Side of Face, Last Treatment | Paired t-test | <0.001 | P-value was based on paired t-test for the mean difference. | Other |
| Independent Reviewer: Both Sides of Face, Last Treatment | Paired t-test | 0.018 | P-value was based on paired t-test for the mean difference. | Other |
| Independent Reviewer: Right Side of Face, Last Treatment | Paired t-test | 0.301 | P-value was based on paired t-test for the mean difference. | Other |
| Independent Reviewer: Left Side of Face, Last Treatment | Paired t-test | 0.011 | P-value was based on paired t-test for the mean difference. | Other |
|
|
| Right Side of the Face, End of study |
|
| Left Side of the Face, Baseline |
|
| Left Side of the Face, End of Study |
|
| <0.001 |
P-value was based on paired t-test for the mean difference. |
| Other |
| Left Side of the Face, End of Study | Paired t-test | <0.001 | P-value was based on paired t-test for the mean difference. | Other |