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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This is a prospective clinical study to demonstrate a reduction in jowling and laxity of the jawline that can be achieved following facial volume enhancement using JUVÉDERM VOLUMA™ XC (0.3% w/w lidocaine). The secondary measure will be if this can be achieved with Jawline injection only, or if a superior result can be obtained with both cheek and jowl injection.
This study is proposed to evaluate the best protocol for achieving improvement in the sagging jawline.
JUVÉDERM VOLUMA™ XC will be injected in each of 16 women with sagging of grades 1-3 using a published jawline evaluation scale.
Patients will be randomized into 1:1 into 2 groups:
Patient Group 1: JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 1-2)
Patient Group 2: JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 2-5)
High-resolution photographs from multiple angles will be taken in identical lighting and position with the VISIA CR (clinical research) and with the Fotofinder at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 or 16 weeks. Additional real-time video telemedicine visits will take place at 6 months and 12 months. In addition, a 72-hour safety phone call will be completed with the subject after each injection session. All visit timing will be based on the last injection session. One blinded dermatologist and one unblinded dermatologist will rate the patient's severity of jowling based on the Jawline Rating Scale (JRS) (1) at the 4-week, 8-week, and either 12 or 16-week visits. The patient will also rate their jowling based on the JRS as well as their satisfaction with the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Experimental | JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 2-5) |
|
| Jawline Injections | Experimental | JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 1-2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM VOLUMA™ XC | Device | Injectable gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. | The primary outcome is a reduction of 1 or more points of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) at baseline versus that at 4 weeks from the last injection (whether initial or touch-up) based on one blinded dermatologist rating. (A lower number will mean a better outcome) All subject data in respective groups were averaged into a single value at each time point. To clarify the Time Point "4 Weeks from last injection" it means 8 to 12 weeks after baseline as subjects were eligible for treatment 4 weeks after baseline and possible retreatment 8 weeks after baseline. The study wanted to capture results 4 weeks after last injection. | Baseline to 4 weeks after last injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. | One of the secondary outcomes is a reduction of 1 or more points of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) at baseline versus that at 4 weeks from the last injection (whether initial or touch-up) based on one unblinded dermatologist rating. (A lower number will mean a better outcome). To clarify the Time Point "4 Weeks from last injection" it means 8 to 12 weeks after baseline as subjects were eligible for treatment 4 weeks after baseline and possible retreatment 8 weeks after baseline. The study wanted to capture results 4 weeks after last injection. Scale Range Description 0 = No sagging
|
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Amy Taub, MD | Advanced Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Dermatology | Lincolnshire | Illinois | 60069 | United States |
Photographs were obtained prior to randomization and treatment.
Participants were recruited based on physician referral and review of clinic's electronic medical records at one clinical medical center between August 2020 and August 2021. The first participant was enrolled on September 25, 2020 and the last participant was enrolled in September 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Jawline Injections | JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 1-2) JUVÉDERM VOLUMA™ XC: Injectable gel |
| FG001 | Both Jawline and Lateral (Zygomatic) Cheek Area Injections | JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 2-5) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Female subjects with jowls with severity grade 2-3 on the Merz Jawline Scale.
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| ID | Title | Description |
|---|---|---|
| BG000 | Jawline Injections | JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 1-2) JUVÉDERM VOLUMA™ XC: Injectable gel |
| 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 | Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. | The primary outcome is a reduction of 1 or more points of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) at baseline versus that at 4 weeks from the last injection (whether initial or touch-up) based on one blinded dermatologist rating. (A lower number will mean a better outcome) All subject data in respective groups were averaged into a single value at each time point. To clarify the Time Point "4 Weeks from last injection" it means 8 to 12 weeks after baseline as subjects were eligible for treatment 4 weeks after baseline and possible retreatment 8 weeks after baseline. The study wanted to capture results 4 weeks after last injection. | Intent to treat population (participants assigned to jawline injections versus both jawline and lateral (zygomatic) cheek area injections). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 4 weeks after last injection. |
|
12 months after last treatment
Adverse events were monitored at every patient visit and through patient safety diaries completed daily for 1 month following 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 | Jawline Injections | JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 1-2) JUVÉDERM VOLUMA™ XC: Injectable gel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
The limitations and caveats are the following: Small sample size, limited to females only, interrupted by COVID with some discontinuous visits, 2 patients were evaluated as mild at baseline by the blinded physician and they should have been excluded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Forman Taub | Advanced Dermatology | 8474596400 | drtaub@advdermatology.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2020 | Dec 16, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 20, 2020 | Dec 16, 2022 | ICF_001.pdf |
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| Baseline to 4 weeks after last injection. |
| Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. | One of the secondary outcomes is a reduction of 1 or more points of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) at baseline versus that at 4 weeks from the last injection (whether initial or touch-up) based on each subjects' ratings. (A lower number will mean a better outcome) To clarify the Time Point "4 Weeks from last injection" it means 8 to 12 weeks after baseline as subjects were eligible for treatment 4 weeks after baseline and possible retreatment 8 weeks after baseline. The study wanted to capture results 4 weeks after last injection. Scale Range Description 0 = No sagging
| Baseline to 4 weeks after last injection. |
| Number of Participants With Abnormal Confrontational Visual Fields Exam Findings | -Ophthalmologic exams that include Confrontational Visual Fields Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. | From initial treatment visit until12 weeks post last injection |
| Number of Participants With Abnormal Eye Exam Findings | -Ophthalmologic exams that include Snellen Eye Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. The Snellen Eye Exam measures visual acuity, by reading a Snellen chart from 20 feet away. The farther down the chart the patient can read, the better their visual acuity is. | From initial treatment visit until12 weeks post last injection |
| Number of Participants With Abnormal Ocular Motility Exam Findings | -Ophthalmologic exams that include Ocular Motility Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. Ocular motility examination is a binocular exam without the patient's glasses. Each eye of the subject is assessed for abnormalities in six positions of gaze: elevation upper lateral, elevation upper medial, elevation central, depression inferior lateral, depression inferior medial, and depression central. | From initial treatment visit until 12 weeks post final injection |
| Number of Participants With Abnormal Cranial Nerves II, III, IV and VII Assessments Findings | To further assess vision and oculomotor function, cranial nerves II, III, IV, and VII will be assessed (left and right sides separately). To assess lower face function, cranial nerves V, VII, IX, X and XII will be assessed. Individual tests will be rated (normal, abnormal that is not clinically significant, and abnormal that is clinically significant) assessing the function of the cranial nerves. These exams will be performed prior to any treatment, 30 minutes after treatment, and at all follow up visits. | From initial treatment visit until 12 weeks post last injection |
| Number of Participants With Adverse Events | Adverse events will be recorded until 12 months after last treatment. All study visits will assess Adverse Events: Treatment visits, 72 hr post Treatments, Week 2, Week 4, Week 8, Week 12/16, 6 Month and 12 Month follow-up visits. | From initial treatment visit until 12 months after last injection treatment |
| Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. | One of the secondary outcomes is a statistically significant difference of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) when comparing group 1 (Jawline Injections) and group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) 4 weeks from the last injection (whether initial or touch-up) based on one blinded dermatologist rating. (A lower number will mean a better outcome). Photos will be taken at Baseline and 4 weeks after last injection treatment | From Baseline to 4 weeks after last injection |
| Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. | One of the secondary outcomes is a statistically significant difference of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) when comparing group 1 (Jawline Injections) and group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) 4 weeks from the last injection (whether initial or touch-up) based on one unblinded dermatologist rating. (A lower number will mean a better outcome) | From Baseline until 4 weeks after last injection |
| Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. | One of the secondary outcomes is a statistically significant difference of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) when comparing group 1 (Jawline Injections) and group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) 4 weeks from the last injection (whether initial or touch-up) based on subjects' ratings. (A lower number will mean a better outcome) | From Baseline until 4 weeks after last injection |
| BG001 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections |
JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 2-5) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Moderate to Severe Jowl Severity | Name of scale and what it measures: Merz Jawline Rating Scale which measures the degree of Jowl sagging. Scale range: 0 = No sagging
Better outcome: Reduced sagging/lower number on scale | Mean | Standard Deviation | Jawline Rating Scale units. Range 0 to 4 |
|
| Jawline Injections |
JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 1-2) JUVÉDERM VOLUMA™ XC: Injectable gel |
| OG001 | Both Jawline and Lateral (Zygomatic) Cheek Area Injections | JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 2-5) |
|
|
|
| Secondary | Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. | One of the secondary outcomes is a reduction of 1 or more points of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) at baseline versus that at 4 weeks from the last injection (whether initial or touch-up) based on one unblinded dermatologist rating. (A lower number will mean a better outcome). To clarify the Time Point "4 Weeks from last injection" it means 8 to 12 weeks after baseline as subjects were eligible for treatment 4 weeks after baseline and possible retreatment 8 weeks after baseline. The study wanted to capture results 4 weeks after last injection. Scale Range Description 0 = No sagging
| Intent to treat population (participants assigned to jawline injections versus both jawline and lateral (zygomatic) cheek area injections). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 4 weeks after last injection. |
|
|
|
|
| Secondary | Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. | One of the secondary outcomes is a reduction of 1 or more points of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) at baseline versus that at 4 weeks from the last injection (whether initial or touch-up) based on each subjects' ratings. (A lower number will mean a better outcome) To clarify the Time Point "4 Weeks from last injection" it means 8 to 12 weeks after baseline as subjects were eligible for treatment 4 weeks after baseline and possible retreatment 8 weeks after baseline. The study wanted to capture results 4 weeks after last injection. Scale Range Description 0 = No sagging
| Intent to treat population (participants assigned to jawline injections versus both jawline and lateral (zygomatic) cheek area injections). | Posted | Mean | Standard Deviation | score on a scale | Baseline to 4 weeks after last injection. |
|
|
|
|
| Secondary | Number of Participants With Abnormal Confrontational Visual Fields Exam Findings | -Ophthalmologic exams that include Confrontational Visual Fields Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. | Posted | Count of Participants | Participants | From initial treatment visit until12 weeks post last injection |
|
|
|
| Secondary | Number of Participants With Abnormal Eye Exam Findings | -Ophthalmologic exams that include Snellen Eye Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. The Snellen Eye Exam measures visual acuity, by reading a Snellen chart from 20 feet away. The farther down the chart the patient can read, the better their visual acuity is. | Posted | Count of Participants | Participants | From initial treatment visit until12 weeks post last injection |
|
|
|
| Secondary | Number of Participants With Abnormal Ocular Motility Exam Findings | -Ophthalmologic exams that include Ocular Motility Exam will be performed prior to any treatment, 30 minutes after treatment, and at all follow up in-person visits. Ocular motility examination is a binocular exam without the patient's glasses. Each eye of the subject is assessed for abnormalities in six positions of gaze: elevation upper lateral, elevation upper medial, elevation central, depression inferior lateral, depression inferior medial, and depression central. | Posted | Count of Participants | Participants | From initial treatment visit until 12 weeks post final injection |
|
|
|
| Secondary | Number of Participants With Abnormal Cranial Nerves II, III, IV and VII Assessments Findings | To further assess vision and oculomotor function, cranial nerves II, III, IV, and VII will be assessed (left and right sides separately). To assess lower face function, cranial nerves V, VII, IX, X and XII will be assessed. Individual tests will be rated (normal, abnormal that is not clinically significant, and abnormal that is clinically significant) assessing the function of the cranial nerves. These exams will be performed prior to any treatment, 30 minutes after treatment, and at all follow up visits. | Posted | Number | participants | From initial treatment visit until 12 weeks post last injection |
|
|
|
| Secondary | Number of Participants With Adverse Events | Adverse events will be recorded until 12 months after last treatment. All study visits will assess Adverse Events: Treatment visits, 72 hr post Treatments, Week 2, Week 4, Week 8, Week 12/16, 6 Month and 12 Month follow-up visits. | Posted | Number | number of subjects with Adverse Events | From initial treatment visit until 12 months after last injection treatment |
|
|
|
| Secondary | Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. | One of the secondary outcomes is a statistically significant difference of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) when comparing group 1 (Jawline Injections) and group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) 4 weeks from the last injection (whether initial or touch-up) based on one blinded dermatologist rating. (A lower number will mean a better outcome). Photos will be taken at Baseline and 4 weeks after last injection treatment | Posted | Mean | Standard Deviation | score on a scale | From Baseline to 4 weeks after last injection |
|
|
|
| Secondary | Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. | One of the secondary outcomes is a statistically significant difference of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) when comparing group 1 (Jawline Injections) and group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) 4 weeks from the last injection (whether initial or touch-up) based on one unblinded dermatologist rating. (A lower number will mean a better outcome) | Posted | Mean | Standard Deviation | score on a scale | From Baseline until 4 weeks after last injection |
|
|
|
| Secondary | Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 for Group 1 (Jawline Injections) Versus Group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) at 4 Weeks After Last Injection. | One of the secondary outcomes is a statistically significant difference of the Jawline Rating Scale (JRS) Assessment (on a scale of 0 to 4) when comparing group 1 (Jawline Injections) and group 2 (Jawline and Lateral Zygomatic Cheek Area Injections) 4 weeks from the last injection (whether initial or touch-up) based on subjects' ratings. (A lower number will mean a better outcome) | Posted | Mean | Standard Deviation | score on a scale | From Baseline until 4 weeks after last injection |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | Both Jawline and Lateral (Zygomatic) Cheek Area Injections | JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area (preauricular area) (the latter area will be added if necessary to achieve visual improvement in jowl attenuation). Total syringes used per person will have a range of 2-5) | 0 | 7 | 0 | 7 | 7 | 7 |
| mild discomfort with chewing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Mild jaw ache | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Moderate jaw ache | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Moderate discomfort with chewing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Lumps/bumps mass or nodule | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Firmness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Cheek pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ear ache | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Inability to fully extend jaw | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bilateral eyelid droop | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Moderate bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| arm or leg numbness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| Mean Reduction in Jawline Rating Score Baseline vs 4 Weeks after last injection |
|
| Superiority |
| The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection. | t-test, 2 sided | The df = 13 for jawline and lateral (zygomatic) cheek area injections arm analysis of Jawline Rating Scale Assessments given by unblinded physician. | 0.0000728 | The threshold for statistical significance was p = 0.05. | Mean Difference (Final Values) | -0.714 | Standard Deviation | 0.497 | 2-Sided | Treatment Difference = 4 Weeks after last injection - Baseline | Superiority |
| Mean Reduction in Jawline Rating Score Baseline vs 4 Weeks after last injection |
|
| Superiority |
| The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection. | t-test, 2 sided | The df = 13 for jawline and lateral (zygomatic) cheek area injections analysis of Jawline Rating Scale Assessments given by the subjects. | 0.0065 | The threshold for statistical significance was p = 0.05. | Mean Difference (Final Values) | -0.714 | Standard Deviation | 0.726 | 2-Sided | Treatment Difference = 4 Weeks after last injection - Baseline | Superiority |
| Mild Jaw Ache |
|
| Moderate Jaw Ache |
|
| Moderate Discomfort With Chewing |
|
| Swelling |
|
| Lumps/Bumps |
|
| Redness |
|
| Firmness |
|
| Headache |
|
| Cheek Pain |
|
| Ear Ache |
|
| Inability to Fully Extend Jaw |
|
| Bilateral Eyelid Drooping |
|
| Basal Cell Carcinoma |
|
| Right Arm and Right Leg Numbness |
|
| Moderate Bruising |
|