Adults 35 to 75, female only, with Jowls. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Blinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.Primary· 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. Th
Mean Jawline Rating Scores at baseline
Group
Value
95% CI
Jawline Injections
2.214
± .699
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
2.071
± .616
Mean Jawline Rating Scores at 4 weeks after last injection
Group
Value
95% CI
Jawline Injections
1.857
± 0.864
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
1.857
± 0.864
Reduction in Jawline rating score Baseline vs 4 Weeks after last injection
Group
Value
95% CI
Jawline Injections
.357
± .864
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
.214
± .864
Unblinded Physician Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.Secondary· 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 De
Mean Jawline Rating Scores at Baseline
Group
Value
95% CI
Jawline Injections
2.357
± 0.497
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
2.357
± 0.497
Mean Jawline Rating Scores at 4 weeks after last injection
Group
Value
95% CI
Jawline Injections
1.357
± 0.497
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
1.643
± 0.497
Mean Reduction in Jawline Rating Score Baseline vs 4 Weeks after last injection
Group
Value
95% CI
Jawline Injections
1.0
± 0.497
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
.714
± 0.497
Subject Jawline Rating Scale (JRS) Assessment on Scale of 0 to 4 at Baseline Versus 4 Weeks After Last Injection.Secondary· 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 =
Mean Jawling Rating Scores at Baseline
Group
Value
95% CI
Jawline Injections
2.286
± 0.469
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
2.429
± 0.514
Mean Jawline Rating Scores at 4 weeks after last injection
Group
Value
95% CI
Jawline Injections
1.714
± 0.611
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
1.714
± 0.726
Mean Reduction in Jawline Rating Score Baseline vs 4 Weeks after last injection
Group
Value
95% CI
Jawline Injections
.571
± .545
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
.714
± .629
Number of Participants With Abnormal Confrontational Visual Fields Exam FindingsSecondary· 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.
Group
Value
95% CI
Jawline Injections
0
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
0
Number of Participants With Abnormal Eye Exam FindingsSecondary· 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.
Group
Value
95% CI
Jawline Injections
0
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
0
Number of Participants With Abnormal Ocular Motility Exam FindingsSecondary· 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.
Group
Value
95% CI
Jawline Injections
0
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
0
Number of Participants With Abnormal Cranial Nerves II, III, IV and VII Assessments FindingsSecondary· 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.
Group
Value
95% CI
Jawline Injections
1
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
0
Number of Participants With Adverse EventsSecondary· 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.
Mild Bruising
Group
Value
95% CI
Jawline Injections
2
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
6
Mild Discomfort With Chewing
Group
Value
95% CI
Jawline Injections
6
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
3
Mild Jaw Ache
Group
Value
95% CI
Jawline Injections
4
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
5
Moderate Jaw Ache
Group
Value
95% CI
Jawline Injections
1
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
0
Moderate Discomfort With Chewing
Group
Value
95% CI
Jawline Injections
1
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
0
Swelling
Group
Value
95% CI
Jawline Injections
0
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
2
Lumps/Bumps
Group
Value
95% CI
Jawline Injections
1
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
2
Redness
Group
Value
95% CI
Jawline Injections
0
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
1
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.Secondary· 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
Group
Value
95% CI
Jawline Injections
1.857
± .8644
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
1.857
± .8644
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.Secondary· 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)
Group
Value
95% CI
Jawline Injections
1.357
± .497
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
1.643
± .497
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.Secondary· 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)
Group
Value
95% CI
Jawline Injections
1.714
± .611
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
1.714
± .726
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months after last treatment.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Jawline Injections
Serious: 0/7 (0%)
Deaths: 0/7
Both Jawline and Lateral (Zygomatic) Cheek Area Injections
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Advanced Dermatology
Last refreshed: 15 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04389866.