Jowls
Conditions
Keywords
Jowls, Lower Face Laxity, Filler, JUVÉDERM VOLUMA™ XC., Melolabial Folds, Wrinkles
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.
Interventions
DEVICEJUVÉDERM VOLUMA™ XC
Injectable gel
Sponsors
Allergan
Advanced Dermatology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Jowling grade 2-3 by the Lower Face Jawline at Rest Scale (1), by both MD evaluator and patient. 2. Female patients must not be pregnant or trying to get pregnant and must have negative pregnancy tests before treatment. 3. Non-pregnant females ages 35-75 in good general health. 4. A study participant must be able to give proper informed consent in writing and be willing to follow the treatment schedule and undertake to carry out all necessary precautions and instructions. 5. Able to participate in telemedicine video visits. 6. Able to understand the requirements of the study and willing and able to follow all study procedures and attend all study visits, and successfully complete the study. 7. Willing to refrain from any other cosmetic procedures on the face including surgery, thread lifting, botulinum toxin in the masseters, jawline, neck, lips or chin, chemical peels, lasers or energy-based devices meant to improve volume or laxity of the face, and additional injectable fillers from the first visit through 12 months after last injection session.
Exclusion criteria
1. Pregnancy or nursing 2. Hyaluronic acid filler injections in the past 6 months in the lower face or unwilling to refrain from such injections other than in the study for the duration of the study. 3. Radiesse or Sculptra in the past 24 months in the lower face 4. Permanent fillers or injectable fat at any time in the past. 5. Facial surgery, tissue tightening, or laser treatments within the past 24 months in the lower face, or unwilling to refrain from having these treatments for the duration of the study. 6. History of keloid or scar formation 7. Unwillingness to refrain from excessive sun exposure or tanning beds during the healing process 8. Taking any medications or supplements that will increase the potential for bruising, or discontinuation of same for 10 days prior to the procedure if medically allowed. These include but are not limited to aspirin of any dosage, any prescription blood thinner, vitamin E, and fish oil. 9. Any of the following significant medical problems: diabetes, obesity, autoimmune disease, cancer, inflammation at the site of injection, current infection any place on the body, dental work in the prior 2 weeks or scheduled for the post-treatment 2-week period, dementia, facial nerve abnormalities, history of blood clots, Bell's Palsy or any neurological condition affecting the facial muscles or nerves. 10. Prior tattoos, piercings, facial hair, or scars below and including the subnasal area that could interfere with visual assessment of the chin, jowls, jawline, and could promote bias in the evaluation of improvement or safety. 11. Known allergy or sensitivity to any components of the injection material, lidocaine, or hyaluronidase. 12. Current enrollment in any other investigational drug or device trial. 13. Any condition that the investigator believes might interfere with study results or put the subject at significant risk with participation. 14. Patients planning to undergo any dental procedure (other than prophylaxis and dental) fillings) during the study will be excluded in order to reduce risks related to seeding infection during injections. 15. Patients who have undergone mesotherapy or cosmetic treatment (laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck, or botulinum toxin treatment below the subnasal region (including injections to the masseter muscles) within 6 months before enrollment or was planning to undergo any of these procedures during the study. 16. Patients who experienced trauma to the chin and jaw area within 6 months before enrollment or had residual deficiencies, deformities, or scarring. 17. Patients with a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein, or was planning to undergo desensitization therapy during the term of the study. 18. Patients who had porphyria, untreated epilepsy, or active autoimmune disease. 19. Patients who had current cutaneous or mucosal inflammatory or infectious processes (e.g., acne, herpes, gum disease), abscess, an unhealed wound, or a cancerous or precancerous lesion, below the subnasal (study device injection may have been delayed for participants with a history of recurrent oral herpes lesions who take prophylactic doses of antiviral/herpes medication for at least 2 days before study treatment administration) 20. Patients on a concurrent regimen of lidocaine or structurally-related local anesthetics (e.g., bupivacaine) or was on a concurrent regimen of drugs that reduce or inhibit hepatic metabolism (e.g., cimetidine, beta-blockers) 21. Patients on a regimen of anticoagulation therapy (e.g., warfarin, clopidogrel) or other prescription anticoagulation therapy. 22. Patients on a regimen of medications (e.g., aspirin or ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or Gingko Biloba) within 10 days of undergoing study device injection (study device injection may have been delayed as necessary to accommodate this 10-day washout period) 23. Patients who received any investigational product within 30 days prior to study enrollment or were planning to participate in another investigation during the course of this study. 24. Patients who have begun using any new over-the-counter or prescription oral or topical, anti-wrinkle products below the subnasal area within 30 days before enrollment or was planning to begin using such products during the study (participants who had been on a regimen of such products for at least 30 days were eligible for the study if they intended to continue their regimen throughout the study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 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. |
| 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 |
| 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. |
| 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 |
| 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) |
| 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 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Photographs were obtained prior to randomization and treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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) | 7 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient with COVID-19 exposure concerns 03Dec2020 | 1 | 1 |
Baseline characteristics
| Characteristic | Jawline Injections | Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Total |
|---|---|---|---|
| Age, Continuous | 53.65 years | 59.47 years | 56.92 years |
| Moderate to Severe Jowl Severity | 2.214 Jawline Rating Scale units. Range 0 to 4 STANDARD_DEVIATION 0.699 | 2.071 Jawline Rating Scale units. Range 0 to 4 STANDARD_DEVIATION 0.616 | 2.143 Jawline Rating Scale units. Range 0 to 4 STANDARD_DEVIATION 0.651 |
| Race/Ethnicity, Customized White, hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White, non-hispanic | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 7 / 7 | 7 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Jawline Injections | 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 0.699 |
| Jawline Injections | 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 |
| Jawline Injections | 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 0.864 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 | 2.071 score on a scale | Standard Deviation 0.616 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 | .214 score on a scale | Standard Deviation 0.864 |
Comparison: The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.p-value: 0.018t-test, 2 sided
Comparison: 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 blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.p-value: 0.082t-test, 2 sided
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
Time frame: From Baseline to 4 weeks after last injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jawline Injections | 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 0.8644 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 0.8644 |
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.
Time frame: From initial treatment visit until12 weeks post last injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jawline Injections | Number of Participants With Abnormal Confrontational Visual Fields Exam Findings | 0 Participants |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Abnormal Confrontational Visual Fields Exam Findings | 0 Participants |
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.
Time frame: From initial treatment visit until 12 weeks post last injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Jawline Injections | Number of Participants With Abnormal Cranial Nerves II, III, IV and VII Assessments Findings | 1 participants |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Abnormal Cranial Nerves II, III, IV and VII Assessments Findings | 0 participants |
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.
Time frame: From initial treatment visit until12 weeks post last injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jawline Injections | Number of Participants With Abnormal Eye Exam Findings | 0 Participants |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Abnormal Eye Exam Findings | 0 Participants |
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.
Time frame: From initial treatment visit until 12 weeks post final injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jawline Injections | Number of Participants With Abnormal Ocular Motility Exam Findings | 0 Participants |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Abnormal Ocular Motility Exam Findings | 0 Participants |
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.
Time frame: From initial treatment visit until 12 months after last injection treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Jawline Injections | Number of Participants With Adverse Events | Mild Discomfort With Chewing | 6 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Headache | 1 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Swelling | 0 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Cheek Pain | 0 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Moderate Jaw Ache | 1 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Ear Ache | 1 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Lumps/Bumps | 1 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Inability to Fully Extend Jaw | 1 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Mild Jaw Ache | 4 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Bilateral Eyelid Drooping | 0 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Redness | 0 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Basal Cell Carcinoma | 0 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Moderate Discomfort With Chewing | 1 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Right Arm and Right Leg Numbness | 0 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Firmness | 2 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Moderate Bruising | 0 number of subjects with Adverse Events |
| Jawline Injections | Number of Participants With Adverse Events | Mild Bruising | 2 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Moderate Bruising | 1 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Mild Bruising | 6 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Mild Discomfort With Chewing | 3 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Mild Jaw Ache | 5 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Moderate Jaw Ache | 0 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Moderate Discomfort With Chewing | 0 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Swelling | 2 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Lumps/Bumps | 2 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Redness | 1 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Firmness | 3 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Headache | 0 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Cheek Pain | 3 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Ear Ache | 0 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Inability to Fully Extend Jaw | 0 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Bilateral Eyelid Drooping | 1 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Basal Cell Carcinoma | 2 number of subjects with Adverse Events |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | Number of Participants With Adverse Events | Right Arm and Right Leg Numbness | 1 number of subjects with Adverse Events |
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 1. = Mild sagging 2. = Moderate sagging 3. = Severe sagging 4. = Very Severe sagging
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Jawline Injections | 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 |
| Jawline Injections | 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 |
| Jawline Injections | 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 0.545 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 | 2.429 score on a scale | Standard Deviation 0.514 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 0.726 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 | .714 score on a scale | Standard Deviation 0.629 |
Comparison: The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection 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.p-value: 0.014t-test, 2 sided
Comparison: 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.p-value: 0.0065t-test, 2 sided
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)
Time frame: From Baseline until 4 weeks after last injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jawline Injections | 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 0.611 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 0.726 |
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 1. = Mild sagging 2. = Moderate sagging 3. = Severe sagging 4. = Very Severe sagging
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Jawline Injections | 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 |
| Jawline Injections | 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 |
| Jawline Injections | 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 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 | 1.643 score on a scale | Standard Deviation 0.497 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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 | .714 score on a scale | Standard Deviation 0.497 |
Comparison: The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection 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.p-value: 3.1e-7t-test, 2 sided
Comparison: 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.p-value: 0.0000728t-test, 2 sided
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)
Time frame: From Baseline until 4 weeks after last injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jawline Injections | 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 0.497 |
| Both Jawline and Lateral (Zygomatic) Cheek Area Injections | 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. | 1.643 score on a scale | Standard Deviation 0.497 |