Trial Outcomes & Findings for Jowl Improvement With Injectable Fillers (NCT NCT04389866)

Last Updated: 2024-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Baseline to 4 weeks after last injection.

Results posted on

2024-02-15

Participant Flow

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.

Photographs were obtained prior to randomization and treatment.

Participant milestones

Participant milestones
Measure	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	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)
Overall Study STARTED	8	8
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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)
Overall Study Patient with COVID-19 exposure concerns 03Dec2020	1	1

Baseline Characteristics

Jowl Improvement With Injectable Fillers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)	Total n=14 Participants Total of all reporting groups
Age, Continuous	53.65 years n=5 Participants	59.47 years n=7 Participants	56.92 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White, non-hispanic	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized White, hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Moderate to Severe Jowl Severity	2.214 Jawline Rating Scale units. Range 0 to 4 STANDARD_DEVIATION .699 • n=5 Participants	2.071 Jawline Rating Scale units. Range 0 to 4 STANDARD_DEVIATION .616 • n=7 Participants	2.143 Jawline Rating Scale units. Range 0 to 4 STANDARD_DEVIATION .651 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 4 weeks after last injection.

Population: Intent to treat population (participants assigned to jawline injections versus both jawline and lateral (zygomatic) cheek area injections).

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Mean Jawline Rating Scores at baseline	2.214 score on a scale Standard Deviation .699	2.071 score on a scale Standard Deviation .616
Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Mean Jawline Rating Scores at 4 weeks after last injection	1.857 score on a scale Standard Deviation 0.864	1.857 score on a scale Standard Deviation 0.864
Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Reduction in Jawline rating score Baseline vs 4 Weeks after last injection	.357 score on a scale Standard Deviation .864	.214 score on a scale Standard Deviation .864

SECONDARY outcome

Timeframe: Baseline to 4 weeks after last injection.

Population: Intent to treat population (participants assigned to jawline injections versus both jawline and lateral (zygomatic) cheek area injections).

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 1. = Mild sagging 2. = Moderate sagging 3. = Severe sagging 4. = Very Severe sagging

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Mean Jawline Rating Scores at 4 weeks after last injection	1.357 score on a scale Standard Deviation 0.497	1.643 score on a scale Standard Deviation 0.497
Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Mean Jawline Rating Scores at Baseline	2.357 score on a scale Standard Deviation 0.497	2.357 score on a scale Standard Deviation 0.497
Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Mean Reduction in Jawline Rating Score Baseline vs 4 Weeks after last injection	1.0 score on a scale Standard Deviation 0.497	.714 score on a scale Standard Deviation 0.497

SECONDARY outcome

Timeframe: Baseline to 4 weeks after last injection.

Population: Intent to treat population (participants assigned to jawline injections versus both jawline and lateral (zygomatic) cheek area injections).

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 1. = Mild sagging 2. = Moderate sagging 3. = Severe sagging 4. = Very Severe sagging

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Mean Jawling Rating Scores at Baseline	2.286 score on a scale Standard Deviation 0.469	2.429 score on a scale Standard Deviation 0.514
Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Mean Jawline Rating Scores at 4 weeks after last injection	1.714 score on a scale Standard Deviation 0.611	1.714 score on a scale Standard Deviation 0.726
Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection. Mean Reduction in Jawline Rating Score Baseline vs 4 Weeks after last injection	.571 score on a scale Standard Deviation .545	.714 score on a scale Standard Deviation .629

SECONDARY outcome

Timeframe: From initial treatment visit until12 weeks post last injection

-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.

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
Number of Participants With Abnormal Confrontational Visual Fields Exam Findings	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From initial treatment visit until12 weeks post last injection

-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.

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
Number of Participants With Abnormal Eye Exam Findings	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From initial treatment visit until 12 weeks post final injection

-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.

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
Number of Participants With Abnormal Ocular Motility Exam Findings	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From initial treatment visit until 12 weeks post last injection

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.

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
Number of Participants With Abnormal Cranial Nerves II, III, IV and VII Assessments Findings	1 participants	0 participants

SECONDARY outcome

Timeframe: From initial treatment visit until 12 months after last injection treatment

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.

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
Number of Participants With Adverse Events Firmness	2 number of subjects with Adverse Events	3 number of subjects with Adverse Events
Number of Participants With Adverse Events Headache	1 number of subjects with Adverse Events	0 number of subjects with Adverse Events
Number of Participants With Adverse Events Bilateral Eyelid Drooping	0 number of subjects with Adverse Events	1 number of subjects with Adverse Events
Number of Participants With Adverse Events Basal Cell Carcinoma	0 number of subjects with Adverse Events	2 number of subjects with Adverse Events
Number of Participants With Adverse Events Moderate Bruising	0 number of subjects with Adverse Events	1 number of subjects with Adverse Events
Number of Participants With Adverse Events Mild Bruising	2 number of subjects with Adverse Events	6 number of subjects with Adverse Events
Number of Participants With Adverse Events Mild Discomfort With Chewing	6 number of subjects with Adverse Events	3 number of subjects with Adverse Events
Number of Participants With Adverse Events Mild Jaw Ache	4 number of subjects with Adverse Events	5 number of subjects with Adverse Events
Number of Participants With Adverse Events Moderate Jaw Ache	1 number of subjects with Adverse Events	0 number of subjects with Adverse Events
Number of Participants With Adverse Events Moderate Discomfort With Chewing	1 number of subjects with Adverse Events	0 number of subjects with Adverse Events
Number of Participants With Adverse Events Swelling	0 number of subjects with Adverse Events	2 number of subjects with Adverse Events
Number of Participants With Adverse Events Lumps/Bumps	1 number of subjects with Adverse Events	2 number of subjects with Adverse Events
Number of Participants With Adverse Events Redness	0 number of subjects with Adverse Events	1 number of subjects with Adverse Events
Number of Participants With Adverse Events Cheek Pain	0 number of subjects with Adverse Events	3 number of subjects with Adverse Events
Number of Participants With Adverse Events Ear Ache	1 number of subjects with Adverse Events	0 number of subjects with Adverse Events
Number of Participants With Adverse Events Inability to Fully Extend Jaw	1 number of subjects with Adverse Events	0 number of subjects with Adverse Events
Number of Participants With Adverse Events Right Arm and Right Leg Numbness	0 number of subjects with Adverse Events	1 number of subjects with Adverse Events

SECONDARY outcome

Timeframe: From Baseline to 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

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
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.	1.857 score on a scale Standard Deviation .8644	1.857 score on a scale Standard Deviation .8644

SECONDARY outcome

Timeframe: From Baseline until 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)

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
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.	1.357 score on a scale Standard Deviation .497	1.643 score on a scale Standard Deviation .497

SECONDARY outcome

Timeframe: From Baseline until 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)

Outcome measures

Outcome measures
Measure	Jawline Injections n=7 Participants 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 Participants 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)
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.	1.714 score on a scale Standard Deviation .611	1.714 score on a scale Standard Deviation .726

Adverse Events

Jawline Injections

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Both Jawline and Lateral (Zygomatic) Cheek Area Injections

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Amy Forman Taub

Advanced Dermatology

Phone: 8474596400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Jawline Injections n=7 participants at risk 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	Both Jawline and Lateral (Zygomatic) Cheek Area Injections n=7 participants at risk 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)
Skin and subcutaneous tissue disorders Mild bruising	28.6% 2/7 • Number of events 2 • 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.	85.7% 6/7 • Number of events 9 • 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.
Skin and subcutaneous tissue disorders mild discomfort with chewing	85.7% 6/7 • Number of events 6 • 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.	42.9% 3/7 • Number of events 3 • 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.
Skin and subcutaneous tissue disorders Mild jaw ache	57.1% 4/7 • Number of events 5 • 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.	71.4% 5/7 • Number of events 5 • 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.
Skin and subcutaneous tissue disorders Moderate jaw ache	14.3% 1/7 • Number of events 2 • 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.	0.00% 0/7 • 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.
Skin and subcutaneous tissue disorders Moderate discomfort with chewing	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/7 • 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.
Skin and subcutaneous tissue disorders Swelling	0.00% 0/7 • 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.	28.6% 2/7 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Lumps/bumps mass or nodule	14.3% 1/7 • Number of events 2 • 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.	28.6% 2/7 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Redness	0.00% 0/7 • 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.	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Firmness	28.6% 2/7 • Number of events 2 • 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.	42.9% 3/7 • Number of events 3 • 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.
Nervous system disorders Headache	14.3% 1/7 • Number of events 2 • 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.	0.00% 0/7 • 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.
Skin and subcutaneous tissue disorders Cheek pain	0.00% 0/7 • 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.	42.9% 3/7 • Number of events 3 • 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.
Ear and labyrinth disorders Ear ache	14.3% 1/7 • Number of events 1 • 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.	0.00% 0/7 • 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.
Skin and subcutaneous tissue disorders Inability to fully extend jaw	14.3% 1/7 • Number of events 2 • 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.	0.00% 0/7 • 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.
Skin and subcutaneous tissue disorders Bilateral eyelid droop	0.00% 0/7 • 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.	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Basal Cell Carcinoma	0.00% 0/7 • 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.	28.6% 2/7 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Moderate bruising	0.00% 0/7 • 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.	14.3% 1/7 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders arm or leg numbness	0.00% 0/7 • 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.	14.3% 1/7 • Number of events 1 • 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.