Jowl Improvement With Injectable Fillers

Not Applicable

Completed

Conditions: Jowls

Interventions: Device: JUVÉDERM VOLUMA™ XC

Registration Number: NCT04389866

Lead Sponsor: Advanced Dermatology

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Both Jawline and Lateral (Zygomatic) Cheek Area Injections	JUVÉDERM VOLUMA™ XC	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	JUVÉDERM VOLUMA™ XC	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)

Primary Outcome Measures

Name	Time	Method
Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.	Baseline to 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.

Secondary Outcome Measures

Name	Time	Method
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.	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)
Number of Participants With Abnormal Confrontational Visual Fields Exam Findings	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.
Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.	Baseline to 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 1. = Mild sagging 2. = Moderate sagging 3. = Severe sagging 4. = Very Severe sagging
Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.	Baseline to 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 1. = Mild sagging 2. = Moderate sagging 3. = Severe sagging 4. = Very Severe sagging
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.	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
Number of Participants With Abnormal Ocular Motility Exam Findings	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.
Number of Participants With Adverse Events	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.
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.	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)
Number of Participants With Abnormal Eye Exam Findings	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.
Number of Participants With Abnormal Cranial Nerves II, III, IV and VII Assessments Findings	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.