Jowl Improvement With Injectable Fillers: Jawline Injections Alone vs Jawline and Cheek Injections
Phase: NA
Conditions: Jowls
Sponsor: Advanced Dermatology

 
 
Protocol:  
Jowl Improvement with Injectable Fillers: Jaw 
line Injections alone vs Jawline and Cheek Injections 
 
 
 
NCT04389866 
 
 
 
 
 
 
 
 
 
 
 
Document date 
04/24/2020 

Jowl Improvement with Injectable Fillers: 
Jawline Injections alone vs Jawline and Cheek Injections 
Amy Forman Taub, MD 
  
  
  
  
Clinical Investigation Plan 
  
  
  
  
  
  
  
  
Date:                                   04/24/2020 
  
Protocol number:             10001 
  
Version:                           4 
  
  
  
 Investigator:                                                                          
Sponsor: 
  
Dr. Amy Forman Taub                                                                  Advanced Dermatology 
Advanced Dermatology                                                                275 Parkway Drive, Suite 521 
275 Parkway Drive, Suite 521                                     
          Lincolnshire, IL 60069  
Lincolnshire, IL 60069                                                                 Tel: 847-459-6400                                                                     
Tel:  847-459-6400                                                                      Fax: 847-459-4610 
Fax:  847-459-4610                                           
 
 
 
                                                              Funded By: 
                                                              Allergan                        
  
 
 
 
Introduction  
  
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.  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.    
  
 Present methods for treating jowling include: 
            
1.  Temporary, semi-permanent and permanent injectable filler substances 
  
2.  Tissue tightening devices and radiofrequency microneedling 
  
3.  Suture lifts 
  
4.  Surgical implants 
  
5.  Surgical face lifts 
  
Early experimentation by the author with volume replacement using JUVÉDERM VOLUMA® XC has yielded 
good results with an excellent safety profile and minimal downtime or adverse events. This study was 
undertaken to determine if patient satisfaction and results can be measured by a reduction in jowl laxity and 
jawline crispness with apparent lift and whether it is enough to treat the jawline alone or it is best to treat the 
jawline in conjunction with the cheeks.  
 
Study Rationale  
  
Hyaluronic acid fillers are used primarily for the reduction of wrinkles and age-related volume deficits. A 
common complaint of women is the formation of jowls, and they frequently pull up their skin toward their ears 
to indicate an outcome they wish for. In the past, face lift was the principle method to treat this problem, but 
many newer less-invasive techniques attempt to improve this area. One treatment that is a few years old is 
the dissolvable suture lift, targeting the mid cheek and jawline to lift the face.  Another newer technique is the 
radiofrequency needling technique. Older treatments include skin tightening treatments with radiofrequency 
or focused ultrasound.  
 
Many practitioners also use fillers with high G prime along the jawline or lateral face to accomplish improving 
the jowls. This technique, alternatively called “jawline filler, jawline lift”, has not received FDA approval. 
JUVÉDERM VOLUMA® XC injectable gel is currently FDA approved for deep injection in the cheek area to 
correct age-related volume loss. In practice, we have seen the advent of cheek treatments with Voluma 
causing noticeable lifting in the jowls and also the nasolabial fold. However, recent experimentation with filler 
into the mandible lateral to the jowl , sometimes accompanied by injection into the preauricular area by this 
author has revealed that this area has been underrepresented in filler solutions for jowling.  
 
  
 
 
Protocol Summary 
 
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 (1). 
  
Patients will be randomized 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 and with the Fotofinder at 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. Oneblinded 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. 
  
Name and Intended Use of Devices and Medications 
  
Proprietary name:  JUVÉDERM VOLUMA™ XC     
Common name:  non-animal hyaluronic acid 
Intended use:  correction of cheek volume loss 
  
Materials 
  
The devices will be maintained according to the manufacturer's suggested maintenance. The devices will be 
utilized as packaged with only the needles that were included in the packaging and without manipulating the 
filler device or contents. No cannulae will be utilized for this study. 
 
If needed for an adverse event, hyaluronidase will be utilized and will be stored according to manufacturers’ 
specification (Hylenex recombinant hyaluronidase human injection,150 USP units/cc). 
  
  
 
 
 
 
Benefit / Risk Analysis 
  
The benefits of participating in this study are to potentially improve moderate to severe facial volume loss 
leading to an aging appearance, specifically in the jowls.   
 
Commonly reported side effects (SEs) of JUVÉDERM® injectable fillers include, but are not limited to, 
injection-site erythema or redness, swelling, pain, tenderness, discomfort, firmness, lumps/bumps, bruising, 
discoloration, and itching. As most of these risks are common to filler injection procedures, the treating 
physician (TI) will use his/her medical judgment to determine any necessary intervention(s).    
 

Additional risks to undergoing a treatment like this include infection, blindness, stroke, vascular compromise, 
and scarring. More detailed information regarding the possible Adverse Events (AEs), safety assessments, 
and investigator protocol in the event of intravascular injection will be noted below. 
 
This study proposes to evaluate a new indication for JUVÉDERM VOLUMA™ XC, for which the benefit/risk 
profile has not been entirely assessed. While the risks of stroke and blindness may be small, the jawline and 
cheek are highly vascularized areas. Due to limited experience and research associated with dermal filler use 
in this area, the actual risk is unknown.  
Alternatives 
  
Alternatives to treatment include but are not limited to other injectable fillers, surgical implants, and surgery. 
 
 
Study Purpose and Objectives 
  
Purpose:       
 
 
The purpose of this clinical investigation is to study the perceived reduction of jowling 
following a volume replacement treatment using JUVÉDERM VOLUMA™ XC in the jawline 
or in the jawline and the cheek 
 
Primary Objective: 
  
The primary objective of this study is to see that a clinically relevant jowl improvement can be 
achieved with hyaluronic acid filler into the jawline and/or cheek (Endpoint #1). 
The secondary objective is to determine which of the 2 methods (jowl injection alone or jowl 
injection with cheek injection) is superior ( Endpoint #2).   
 
Study Design  
 
Scope:          
 
 
The clinical study will include 16 patients at one clinical site. 
  
 
Duration:       
 
 
Eligible patients will receive 1 treatment according to the study protocol, and will be followed 
for a period of 12 months to document safety and efficacy. Patient and/or doctor may choose 
to have a touchup at 1 month. All subjects will be followed for 12 months from the time of the 
last injection session. 
  
  
 
Patient Selection 
 
Each patient will be evaluated by the Investigator to assess his or her suitability for entry into the study. 
  
 
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 urine 
pregnancy tests before treatment. 
 
3. Non-pregnant females ages 35-65 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 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 clot, 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 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 subject at 
significant risk with participation.  
 
14.  Patients planning to undergo any dental procedure (other than prophylaxis and dental) 
fillings). 
 
15.  Patients who have undergone mesotherapy or cosmetic treatment (laser,               
photomodulation, intense pulsed light, radio frequency, 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 are typically excluded for safety reasons.  
 
18.  Patients who have porphyria, untreated epilepsy or active autoimmune disease.  
 
19. Patients who have 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 a concurrent regimen of drugs that reduce or inhibit hepatic metabolism (e.g., 
cimetidine, beta-blockers). 
 
21. Patients on a regimen of anti-coagulation therapy (e.g., warfarin, clopidogrel) or other 
prescription anti-coagulation 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 
was 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). 
 
25. Patients who have a pigmentation disorder. 
 
26. Patients currently on immunosuppressive therapy for the duration of the study. 
 
27. Patients unwilling to use contraceptive methods to prevent pregnancy for the duration of the 
study. 
 
 
  
 
Information on Gender and Racial Inclusion/participation in study: 
 
Men have been excluded from this study for two reasons:(1) the technique pioneered in this study 
may not give a desirable aesthetic effect for men even if they reach the endpoint of improved jowling, 
due to the fact that they have a different shape of jawline than women and (2) men often need a 
higher amount of filler than women to achieve endpoint and product is limited to grant from Allergan.   
 
The original Voluma study (see Package Insert), showed that there was no difference in response nor 
safety signals depended on Fitzpatrick skin types.  Although this study is looking at a different area of 
study than that already approved (cheeks), there is no reason to presume this would change this 
initial observation. We may not have access to all skin types to recruit for this single center 
Investigator Initiated Clinical Trial, although we will attempt to recruit skin types 4-6. 
 
 
 
 
 
Clinical Procedures 
  
Pre-Procedure Evaluation 
  
1.  At the first visit, the Investigator will obtain a detailed patient history, examine the patient and 
determine if she fits the study criteria.  
  
2.  The Investigator will discuss treatment options with the patient including injectable fillers and 
other treatment modalities. 
  
3.  During the first visit, the physician should obtain an informed consent from the subject, clearly 
indicating his / her understanding of the requirements and risks involved with study participation, 
including but not limited to: 
  
a.  
One to two treatments will be performed using JUVÉDERM VOLUMA™ XC  
 
b.  
A photographic record at baseline and all follow-up visits (2 weeks, 4 weeks, 8 
weeks, 12 weeks, and 16 weeks).  
  

c.  
There may be discomfort / pain / bruising and complete discussion of side effects 
potentially resulting from the treatment, including possible stroke, blindness and scarring 
  
d.  
Transient edema may occur immediately following the treatment. 
  
e.  
Erythema and bruising may occur following treatment and last up two weeks or 
longer. 
  
f.   
A full disclosure and written consent will be provided and signed. 
  
g.  
If necessary as deemed by patient and/or physician, a touch up may be performed at 
the 1-month visit. 
 
h.  Evaluations by phone and/or telemedicine will be performed at 72 hours after treatment, 
6 and 12 months. 
 
                            I. Patients will complete a safety diary daily via email for 30 days following treatments. 
  
  
If the patient passes all of the inclusion and exclusion criteria for entry into the study the investigator will 
obtain signed Informed consent, enroll the patient into the study, and record required data on the appropriate 
study data form. Pre-treatment photographs will be taken.  
 
 
 
 
 
Treatment 
  
1.   Photographs will be taken prior to treatment with the VISIA CR system and Fotofinder and 
with an iPad.  Frontal, 45- and 90-degree angle shots at standard illuminations will be taken. 
  
2. Patients will be randomized to 2 groups: 
  
Patient Group 1:  JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) in will be injected bilaterally 
into the lateral Jawline/lateral medial or 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. 
 
Note: Based on preclinical studies and a toxicological risk assessment, subjects will be limited to 20 mL of 
JUVEDERM VOLUMAXC per 60 kg (130 lbs) body mass per year. This includes any “Touch-up Volume” 
 
 
  
3.  During treatment cold air will be directed toward the injection sites to reduce discomfort. 

  
4.  Any complications will be noted at each visit and the patient will complete a diary via email or 
text every day. 
  
5.  Side Effects and possible adverse reactions will be monitored and documented before and 
after each treatment. Safety measures will be outlined below.  
 
6.   Safety exams will be performed prior to and 30 minutes after treatment. These tests include 
the Snellen Eye Exam, Ocular Motility Exam, and Confrontational Visual Fields Exam. Cranial 
Nerve evaluations will also be performed prior to and 30 minutes after treatment. 
  
7.  The patient will be given postoperative instructions. 
  
8.  Inclusion in the study will require participation in all the follow-up visits. 
  
 
Return Visits 
  
The subject will have a phone call with the study coordinator at 72 hours. 
 
The subject will return at 2 weeks,4 weeks, 8 weeks, and either 12 or 16 weeks following the treatment. 
 
The subject will have a live video telemedicine visit at 6 and 12 months after the last injection session. 
  
At all follow up in person visits, photographs will be taken.  
  
Any side effects or adverse events will be noted at each study visit. Any changes in condition, medical 
history, or medications will be noted.  
 
Safety eye exams will be performed. These tests include the Snellen Eye Exam, Ocular Motility Exam, and 
Confrontational Visual Fields Exam. Cranial Nerve evaluations will also be performed to further assess vision, 
oculomotor function, and lower face function.  
  
Patient questionnaire will be completed noting discomfort from the treatment, downtime following treatment, 
their perception of the results, would they have the treatment performed again in the future if they had the 
choice, and if they feel they need a touch-up (see below). 
 
The patient or treating physician may request one touchup at one month, with the identical amounts and 
procedures as the first injection.  If this takes place, the patient will have another safety phone visit at 72 
hours, another 1-month follow-up visit similar to the first and shall not be eligible for a touch up at the second 
1-month visit.  The patient shall then have a 3 month visit after the second injection as well as a 6- and 12-
month videoconference visit from the second injection. Additional treatment is optional for the patient. 
 
Additional treatment is optional for the patient, but must be agreed upon by both patient and physician that 
additional improvement may be obtained of the jowl by the treatment. 
  
Safety Assessments   
 
Safety measures include:  
 

Ophthalmologic exams that include Snellen Eye Exam, Ocular Motility Exam, and Confrontational Visual 
Fields Exam. These exams will be performed prior to any treatment, 30 minutes after treatment, and at all 
follow up in person visits. Refer to the case report forms (CRFs) for examination procedures. 
 
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. 
These exams will be performed prior to any treatment, 30 minutes after treatment, and at all follow up visits. 
Subjects will also be asked about cranial nerve functionality in their safety diaries. Refer to the case report 
forms (CRFs) for examination procedures and criteria. 
 
Patient will also have a jaw function assessment at all in person visits.  Please refer to the CRF for 
examination procedures and criteria. 
 
Patients will fill out a daily safety diary to monitor for any adverse events. Patients will be instructed to seek 
immediate medical attention if any signs of vascular compromise occur (pain in treatment site, excessive 
redness, purple coloration or blanching (white patches), blisters, and crusts. 
 
Adverse Reactions 
 
AEs will be monitored at every patient visit and through patient safety diaries completed daily for 1 month 
following treatment. Patients will be followed for a period of 12 months after final treatment.  
 
Adverse Events of Special Interest, including vision changes, will be reported to Allergan and the FDA within 
10 days. SAEs will be reported within 24 hours. All other AEs will be reported annually. 
 
More detailed information including the AE report form will be included below.  
 
The following is a list of common anticipated adverse reactions that have been reported with facial injection 
procedures in the area or at the injection site: 
● 
Bleeding 
● 
Bruising  
● 
Redness  
● 
Swelling 
● 
Lumps/bumps mass or nodule 
● 
Itching 
● 
Discoloration  
 
In rare circumstances, facial fillers have been associated with the following severe adverse events (SAEs): 
● 
Allergic reaction 
● 
Herpes Simplex Virus 1 outbreak 
● 
Giant cell reaction or granuloma formation 
● 
Vision changes (blurred vision, double vision, loss of peripheral vision, partial loss of the visual field) 
● 
Blindness (complete or partial) 
● 
Stroke 
● 
Vascular compromise 
● 
Scarring  
● 
Skin necrosis, ulceration and/ or nerve damage 
● 
Inability to chew or speak normally 
 
 
While rare, unintentional injection into a blood vessel has been reported for facial injections which can be 
serious and may be permanent. Any incidence of visual disturbances (including, but not limited to, any loss of 
vision, blurry vision, double vision, pain in or around the eye, blind spot or shadow in the visual field, trouble 

moving eyes, dizziness, confusion, weakness or numbness of the arms or legs, changes to consciousness or 
alertness, difficulty speaking or speech impairment, facial drooping etc.) will be immediately reported to the 
treating physician and the sponsor. In the event of blindness or any ophthalmic signs or symptoms, the 
subjects must undergo immediate evaluation by a retinal specialist. More details pertaining to the reporting 
protocol and treating vascular compromise will be outlined below.  
 
The incidence of serious adverse events associated with intravascular injection is very low. If a 
complication occurs, the subject will be advised to contact the study staff and treating physician 
immediately and the treating physician will use his/her medical judgement to determine the necessary 
interventions to treat the subject.  
 
There are also unforeseeable risks or results associated with this procedure. If the subject experiences any 
unanticipated adverse event an additional visit and/ or report form may be required.  
 
 
 
 
Vascular Compromise Procedure and Protocol  
 
Recognition and Treatment of Vascular Occlusion: 
 
Recognition: 
Recognize vascular occlusion by a livedoid or violaceous appearance to the 
treatment area and/or blanching of the treatment area and/or patient pain.   
 
Early signs: 
• 
Blanching followed by violaceous patches in distribution of artery   
• 
Pain 
* especially if they have had a filler treatment before and it is unusual and/or 
more severe in days following injection 
 
 
 
 
 
 
 
 
 
 

 
 
 
Delayed signs: 
• Violaceous or dusky reticulated patches 
in distribution of arteries 
• Pain 
• Necrosis  
 
 
 
 
 
 
 
Arterial Compromise vs. Bruising: 
• 
Does not typically develop yellow coloration like bruising  
• 
Not typically round or in dependent areas like bruising  
  
 
 
 
 
Treatment: 
When vascular occlusion is suspected, it is crucial that the injection is stopped immediately and treatment is 
rapidly instigated. The objective is to facilitate blood flow to the affected area. The steps for treatment of a 
vascular occlusion are: 
1. Immediately flood the entire treatment area with injected 200-300 U of Hyaluronidase (1.25-2.0 cc of 
Hylenex, 150 u/cc).  
2. Apply a warm compress 
3. Massage the area.   
4. If no reduction in violaceous or blanching appearance and/or pain after 10 minutes, apply 2% 
nitroglycerin paste to promote vasodilatation. 
5. 60 min later if no improvement, reinject 200-300U of hyaluronidase.  
6. Repeat Hourly and daily 
7. If none of these measures work and depending on severity, institute daily hyperbaric oxygen 
chamber treatments.   

Hyaluronidase should be injected immediately, regardless of the filler used, and administered hourly and/or 
daily in liberal doses where signs and symptoms are present. 
When injecting hyaluronidase to treat acute ischemia, consensus recommendations are that the entire 
ischemic area be treated, not just the site where HA was originally injected. Doses up to 1500 U may be 
required to achieve reversal of vascular compromise. 
 
References: 
1. 
Urdiales-Gálvez F, Delgado NE, Figueiredo V, Lajo-Plaza JV, Mira M, Moreno A,  
Ortíz-Martí F, Del Rio-Reyes R, Romero-Álvarez N, Del Cueto SR, Segurado MA, 
Rebenaque CV. Treatment of Soft Tissue Filler Complications: Expert Consensus 
Recommendations. Aesthetic Plast Surg. 2018 Apr;42(2):498-510. doi: 
10.1007/s00266-017-1063-0. Epub 2018 Jan 5. Review. 
 
2. 
Henderson R, Reilly DA, Cooper JS. Hyperbaric Oxygen for Ischemia due to 
Injection of Cosmetic Fillers: Case Report and Issues. Plast Reconstr Surg Glob 
Open. 2018 Jan 11;6(1):e1618. 
 
 
Recognition and Treatment of Retinal Occlusion 
If patient complains of loss of vision, periorbital pain, blurred vision, ptosis, or impairment of extraocular 
muscle functionality immediately perform Snellen Chart Visual Acuity Calculation.   
 
Fortunately, recent review of the literature asserted that the most common locations of injection leading to this 
complication were the forehead, nose and temple, and specifically the jawline was NOT involved in any single 
case  
Nevertheless, preparations will be made in event of this catastrophic complication. There is no definitive and 
completely accepted protocol for treating this complication. 
However, most experts recommend:  
1. Assess visual acuity with Snellen Chart examination 
2. Make sure pupils are round and equal and respond to light. 
3. Immediately arrange for transfer to a retinal surgeon office and transfer at first opportunity (surgeon 
or associate to drive). 
4. Apply 1 drop of Timolol to affected eye. 
5. Begin massage of the eye 
a. Digital massage should start immediately  
b. The patient should be placed in a supine position. 
c. Ensure the patient’s eyes are closed. 
d. Apply firm pressure (enough to ensure that the eyeball is indented about 2–3 mm) on the 
eyeball through the closed eyelids. 
e. Apply firm pressure for 5–15 s and quickly release. 
f. 
Repeat this cycle for at least 5 min. 
6. Flood the area of the supraorbital and supratrochlear notch on the side with deficit with 
hyaluronidase. 

7. Have the patient rebreathe into a plastic or paper bag 
8. Put either 325 mg ASA OR sublingual nitroglycerin 0.6 mg under the patient’s tongue. 
9. Only as a last resort and after blindness has been established by Snellen Chart, Retinal surgeon not 
available, then undertake a retrobulbar injection with hyaluronidase up to 1500 U, as in rare cases, it 
has been effective, although is not recommended due to poor literature and proof. 
 
Retinal Surgeon: 
Michael Blair, MD - Ophthalmologist (Retina Consultants, Ltd) 
C: 847- 217-5436  
O: (847) 299-0700 
michaelblairmd@gmail.com 
 
Aneta  - Practice Manager 
(847) 299-0700 / 0701 (direct #)      Fax: 847.390.0616 
 
 
Mondays: Libertyville 1-4:30 pm 
Tuesdays: Des Plaines 9-12:45 pm; Libertyville 2-4:30 pm  
Wednesdays: Libertyville 12-4:30  
Thursdays: Des Plaines 2 pm- 4:30 pm  
Fridays: Libertyville 1-4:30 pm 
Saturday: 4th Saturday of the month (select)  
 
Main Locations: 
 
2454 E Dempster St Ste 400  
Des Plaines, IL 60016  
13.3 miles from Lincolnshire 
14.2 miles from Glencoe  
 
755 South Milwaukee Ave. 
Suite 101 
Libertyville, IL 60048 
7.2 miles from Lincolnshire  
18.8 miles from Glencoe 
 
 
Other locations:  
 
3100 Ogden Ave. 
Lisle, IL 60532 
 
2250 Point Blvd. 
Suite 120 
Elgin, IL 60123 
 

Hickory Square Plaza 
7667 West 95th St. 
Suite 103 
Hickory Hills, IL 60457 
 
 
.  
 
 
References: 
1. 
Thanasarnaksorn W, Cotofana S, Rudolph C, Kraisak P, Chanasumon N, Suwanchinda 
A. Severe vision loss caused by cosmetic filler augmentation: Case series with review of 
cause and therapy. J Cosmet Dermatol. 2018 Oct;17(5):712-718. 
2. 
J Cosmet Dermatol. 2018 Oct;17(5):712-718. doi: 10.1111/jocd.12705. Epub 2018 Jul 
13. 
3. 
Paap MK, Milman T, Ugradar S, Goldberg R, Silkiss RZ. Examining the Role 
ofRetrobulbar Hyaluronidase in Reversing Filler-Induced Blindness: A Systematic 
Review. Ophthalmic Plast Reconstr Surg. 2019 Dec 24. 
4. 
Kapoor KM, Kapoor P, Heydenrych I, Bertossi D. Vision Loss Associated with 
Hyaluronic Acid Fillers: A Systematic Review of Literature. Aesthetic Plast Surg.2019 
Dec 10. 
 
 
 
 
 
 
 
Discontinuation Criteria 
 
Reasons for early discontinuation from the study for individual subjects include: 

●
Serious Adverse Event (including vascular embolic event, leading to skin necrosis,
vision loss or stroke)
●
Pregnancy
●
Protocol deviation
●
Physician decision
●
Subject withdrawal
●
Lost to follow-up
●
Death
Should any vascular embolic event, vision loss, or stroke occur, the study will be discontinued. 
The enrollment and treatment will be suspended and a root cause investigation will be 
conducted to determine the cause of the event and whether the outcome was anticipated (the 
investigator did not properly follow the treatment SOP) or unanticipated (the investigator DID 
properly follow the treatment SOP). If the event was unanticipated, the study will be 
immediately suspended and enrollment will be halted until the event can be properly 
characterized and an appropriate treatment strategy to avoid this unanticipated event can be 
devised. 
Patients enrolled in the study will be informed of any new events or risks to the study treatment 
and may choose to continue participation or be withdrawn at any time.  
Withdrawal 
Patients enrolled in the study will be free to discontinue their participation in the study at any time.  A decision 
to discontinue participation will not prejudice their medical care.  In those instances, the investigator will 
attempt to obtain clinical results and side effect evaluation concerning the patient prior to his / her withdrawal. 
Details of the subject’s withdrawal from the study will be noted and reported to sponsor.  
Data Analysis 
Data will be collected via digital photographs and questionnaires by the subjects. 
Photographs will remain unretouched. One blinded dermatologist and one unblinded dermatologist will rate 
the patient’s severity of jowling based on the Jawline Rating Scale (JRS) (1) at baseline, the 4-week, 8-week, 
and 12 or 16-week visits.  The patient will also rate their jowling based on the JRS as well as their 
satisfaction with the procedure. 
Analysis of Scientific Soundness of the Protocol 
The proposed study has been designed to provide a valid method to analyze the safety and efficacy of facial 
volume replacement.  Measure taken to assure that the study provides valid data are as follows: 
1.
Photographs will be taken under standardized conditions.  Photographs will be taken with a VISIA
CR, a device made by Canfield Scientific specifically to be utilized for clinical research to provide
uniformity in patient photographs.
2.
Adverse or unanticipated effects that occur during the course of this clinical study will be recorded
and carefully analyzed as to their relationship to the treatment.
3.
Evaluators will review individual photos without knowledge of if they are before or after photos.

 
Primary Outcome Measure: 
 
1. The primary outcome is a reduction of 1 or more points of the Jawline Rating Scale (JRS) 
Assessment (on scale of 0 to 4) at baseline versus that at 4 weeks from the last injection (whether 
initial or touch-up) based on any or all of one blinded dermatologist rating, one unblinded 
dermatologist rating, and patient rating.    (A lower number will mean a better outcome) Time Frame: 
Baseline to 4 weeks after last injection. 
 
 
Secondary Outcome Measures 
 
1. Reduction of 1 or more points of the Jawline Rating Scale (JRS) Assessment (on scale of 0 to 4) at 
baseline versus that at 4 weeks from the last injection based on the patients rating while looking in 
the mirror and at before and after photographs. A lower number will mean a better outcome. Time 
Frame: 4 weeks from last injection 
2.  Whether group 1 and group 2 has a higher reduction in the Jawline Rating Scale (JRS) (on scale of 
0 to 4)  at 4 weeks from the lastinjection compared to baseline based on ratings from one blinded 
dermatologist and one unblinded dermatologist. . A lower number will mean a better outcome. Time 
Frame: 4 weeks from last injection 
3. Whether group 1 or group 2 has a higher reduction in the Jawline Rating Scale (JRS) (on scale of 0 
to 4)  at 4 weeks from the last injection compared to baseline based on the patients rating while 
looking in the mirror and at before and after photographs. . A lower number will mean a better 
outcome. Time Frame: 4 weeks from last injection 
4. Jawline Rating Scale (JRS) Assessment on scale of 0 to 4 at 4 weeks: One blinded dermatologist 
and one unblinded dermatologist will rate the patient's severity of jowling based on the Jawline Rating 
Scale (JRS). The patient will also rate their jowling based on the Jawline Rating Scale (JRS). The 
scale is on a rating of 0 to 4. A lower number will mean a better outcome. [Time Frame: 4 weeks] 
5. Jawline Rating Scale (JRS) Assessment on scale of 0 to 4 at 8 weeks: One blinded dermatologist 
and one unblinded dermatologist will rate the patient's severity of jowling based on the Jawline Rating 
Scale (JRS). The patient will also rate their jowling based on the Jawline Rating Scale (JRS). The 
scale is on a rating of 0 to 4. A lower number will mean a better outcome. [Time Frame: 8 weeks] 
6. Jawline Rating Scale (JRS) Assessment on scale of 0 to 4 at 12 or 16 weeks: One blinded 
dermatologist and one unblinded dermatologist will rate the patient's severity of jowling based on the 
Jawline Rating Scale (JRS). The patient will also rate their jowling based on the Jawline Rating Scale 
(JRS). The scale is on a rating of 0 to 4. A lower number will mean a better outcome. [Time Frame: 3 
months from last treatment] 
7. Incidence of abnormal eye exam (Confrontational Visual Fields Exam) findings (Safety): 
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: up to 18 
months] 
8. Incidence of abnormal eye exam (Snellen Eye Exam) findings (Safety): 
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. [Time Frame: up to 18 months] 
9. Incidence of abnormal eye exam (Ocular Motility Exam) findings (Safety): 
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. [Time Frame: up to 18 months] 
10. Incidence of abnormal cranial nerves II, III, IV and VII assessments findings (Safety): 
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. These exams will be performed prior to any treatment, 30 minutes after treatment, 
and at all follow up visits. [Time Frame: up to 18 months] 
11. Adverse events: 

Adverse events will be recorded until 12 months after last treatment. [Time Frame: up to 12 months 
after last treatment] 
 
 
Adherence to Protocol 
  
The investigator will review the contents of this protocol.  Any alterations to the protocol will be made in 
writing to the sponsor. 
  
  
 
 
 
 
Records and Reports 
  
Data from the pre-treatment evaluation, the treatment procedure, complications, if any, the post-treatment 
evaluation and all follow up evaluations will be recorded on the clinical data forms prepared for the study. 
  
All records and reports concerning the clinical study will be forwarded to the Sponsor within a reasonable 
amount of time. The Investigator shall retain copies of all documentation for a period of two years following 
the date on which the entire clinical investigation is terminated or discontinued. 
  
  
Confidentiality 
  
This study is confidential. Information made public regarding subjects enrolled in this study will not disclose 
the name of any individual. 
 
 
Information made public regarding subjects enrolled in this study will not disclose the name of any individual. 
All our research records are stored securely in locked cabinets and password protected computers. Only a 
few people who are closely concerned with the research will be able to view information from participants.  
Data is coded. 
 
The results of this study will be provided to Allergan, including photographs, but no identifying subject 
information will be disclosed. 
 
The results of this research study may be presented at scientific or medical meetings or published in scientific 
journals. Subject identities will not be disclosed in any of these meetings or publications. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify subjects. At most, the Web site will 
include a summary of the results.   
 
 
Documentation of Consent Process 

 
Consent will be obtained prior to any study procedures being performed. Informed consent will be discussed 
with subject. A copy of the consent form will be provided for subject (in a language understandable to the 
patient) and/or authorized subject representative review. Subject and/or authorized subject representative will 
be given adequate time to read the consent form and discuss the study with study investigators and/or family 
members. All questions will be answered. Subject and/or authorized subject representative will be given time 
to discuss. HIPAA form will be reviewed with subject. Informed Consent process will be conducted in a 
manner and location that ensure patient privacy. 

References 
  
1. Jones K, Moradi A, Narins R, Narurkar V, Flynn T, Verma A.  Development and reliability of a new 
Merz Jawline Grading Scale for photographic and live assessments. 
JAAD. 2017 June; 76(6) S1:AB98. 
 
2.Lorenc ZP, Lee JC. Composite Volumization of the Aging Face: Supra-Periosteal 
Space as the Foundation for Optimal Facial Rejuvenation. J Drugs Dermatol. 2016 
Sep 1;15(9):1136-41. PubMed PMID: 27602979. 
 
3. Dallara JM, Baspeyras M, Bui P, Cartier H, Charavel MH, Dumas L. Calcium 
hydroxylapatite for jawline rejuvenation: consensus recommendations. J Cosmet 
Dermatol. 2014 Mar;13(1):3-14. doi: 10.1111/jocd.12074. PubMed PMID: 24641600. 
 
4. Moy RL, Fincher EF. Poly-L-lactic acid for the aesthetic correction of facial 
volume loss. Aesthet Surg J. 2005 Nov-Dec;25(6):646-8. doi: 
10.1016/j.asj.2005.10.001. PubMed PMID: 19338874. 
 
5. Braz, Andre; Humphrey, Shannon; MD, FRCPC; Weinkle, Susan; Yee, G; Remington, B; Kent MD, 
FRCP; Lorenc, Z; Paul MD, FACS; Yoelin, Steve; Waldorf, Heidi; Azizzadeh, Babak; MD, FACS; 
Butterwick, Kimberly; de Maio, Mauricio; MD, ScM; Sadick, Neil; MD, FAAD;  FAACS, FACP; Trevidic, 
Patrick; Criollo-Lamilla, Gisella; Garcia, Philippe. Lower Face:  Clinical Anatomy and Regional 
Approaches with Injectable Fillers. Plastic &amp; Reconstructive Surgery. 136(5S) Soft-Tissue Fillers and 
Neuromodulators: International and Multidisciplinary Perspectives:235S-257S, November 2015. 
 
6. Bates B. A guide to physical examination and history taking. J.B. Lippincott & Co. 6th 
edition. 1995. Chapter 7:168–9, 172–5; Chapter 18:505–8. 
 
7. Yen TL, Driscoll CL, Lalwani AK. Significance of House-Brackmann facial nerve grading global score in 
the setting of differential facial nerve function. Otol Neurotol. 2003 Jan;24(1):118–22. 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Voluma Jowl/Jawline Study 10001  Appendix 1: Study Schematics Retreatment 
 
Visit # 
     1 
     2 
    3 
     4 
     5 
     6 
    7 
    8 
     9 
    10 
 
Screening 
Treat
ment 
Safety 
Follow 
Up Call 
In 
Office 
Follow 
Up 
In 
Office 
Follow 
Up 
Safety 
Follow 
Up Call 
In  
office 
Follow 
Up 
In  
Office 
Follow 
Up 
Tele 
medicine 
Video 
Call 
Tele 
medicine 
Video Call 
 
 
 
72 hours 
after 
treat 
ment 
2 
weeks 
+/- 3 
days 
4 
weeks 
+/- 3 
days 
72 
hours 
after 
RTx 
8 
weeks 
+/- 3 
days 
16 
weeks 
+/- 3 
days 
6  
months 
after RTx 
+/- 3 days
12  
months  
after RTx 
+/- 3 days 
Informed Consent 
 
     X 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
 
     X 
 
 
 
 
 
 
 
 
 
Medical History 
      
     X 
 
 
 
 
 
 
 
0 
 
Urine Pregnancy 
Test 
   
     X 
 
   X 
 
 
 
   X 
 
 
 
 
 
Photography 
 
 
  X 
 
 
  X 
 
  X 
 
 
  X 
 
   X 
 
 
Blinded Evaluation 
 
    X 
 
 
 
 
 
   X 
 
 
   X 
 
   X 
  
 
 
      
Adverse Events 
 
 
  X 
 
    X 
 
   X 
 
   X 
 
    X 
 
    X 
 
    X 
 
     X 
 
      X 
Physical Exam 
 
 
 X 
 
 
  X 
 
   X 
 
 
  X 
 
  X 
 
 
Safety Eye 
Assessments 
 
 
 X** 
 
 
   X 
 
   X 
 
 
  X 
 
  X 
 
 
Cranial Nerve 
Assessments 
 
 
   X 
 
 
   X 
 
   X 
 
 
  X 
 
   X 
 
    
 
Patient 
Questionnaire/ 
Evaluation 
 
       X 
 
 
     
 
    X 
 
   X 
 
 
   X 
 
   X 
 
     X 
 
     X 
Patient Pain 
Evaluation 
 
 
   X 
 
     X 
 
    X 
 
    X 
 
   X 
 
   X 
 
    X 
 
      X 
 
      X 
Patient Safety 
Diary*** 
 
 
   X 
   
     X 
 
    
    X 
 
    X 
  
     
 
 
 
Retreatment 
 
 
 
 
 
    X* 
 
    
      
     
 
 
 
*If requested by physician or patient and agreeable to both 
**Safety Eye Assessments will be performed prior to treatment and 30 minutes after treatment 
***Patient diary to be completed daily by email for 30 days following treatment 

Voluma Jowl/Jawline Study 10001 Appendix 1: Study Schematics No Retreatment 
 
Visit # 
     1 
     2 
    3 
     4 
     5 
    6 
     7 
     8 
    9 
 
Screening 
Treat
ment 
Safety 
Follow 
Up Call 
In 
Office 
Follow 
Up 
In 
Office 
Follow 
Up 
In  
office 
Follow 
Up 
In  
Office 
Follow 
Up 
Tele 
medicine 
Video 
Call 
Tele 
medicine 
Video 
Call 
 
 
 
72 
hours 
+/- 4 
hours 
2 
weeks 
+/- 3 
days 
4 
weeks 
+/- 3 
days 
8 
weeks 
+/- 3 
days 
12 
weeks 
+/- 3 
days 
6  
months 
after Tx 
+/- 3 
days 
12 
months  
after Tx 
+/- 3 
days 
Informed Consent 
 
     X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
 
     X 
 
 
 
 
 
 
 
 
Medical History 
      
     X 
 
 
 
 
 
 
 
 
Urine Pregnancy 
Test 
 
    X 
 
  X 
 
 
 
 
 
 
 
Photography 
 
 
  X 
 
 
  X 
 
  X 
 
  X 
 
   X 
 
 
Blinded Evaluation 
 
    X 
 
 
 
   
 
   X 
 
   X 
 
   X 
  
 
 
      
Adverse Events 
 
 
  X 
 
    X 
 
   X 
 
   X 
 
    X 
 
    X 
 
     X 
 
      X 
Physical Exam 
 
 
 X 
 
 
  X 
 
   X 
 
  X 
 
  X 
 
 
Safety Eye 
Assessments 
 
 
 X* 
 
 
   X 
 
   X 
 
  X 
 
  X 
 
 
Cranial Nerve 
Assessments 
 
 
   X 
 
 
   X 
 
   X 
 
  X 
 
   X 
 
    
 
Patient 
Questionnaire/ 
Evaluation 
 
       X 
 
 
     
 
    X 
 
   X 
 
   X 
 
   X 
 
     X 
 
     X 
Patient Pain 
Evaluation 
 
 
   X 
 
     X 
 
    X 
 
    X 
 
   X 
 
    X 
 
      X 
 
      X 
Patient Safety 
Diary** 
 
 
   X 
   
     X 
 
 
  
     
 
 
 
Retreatment*** 
 
 
 
 
 
    
      
     
 
 
 
* Safety Eye Assessments will be performed prior to treatment and 30 minutes after treatment 
**Patient diary to be completed daily by email for 30 days following treatment 
***No Retreatment done per patient and/or physician 

 Jowl Improvement with Injectable Fillers: Jawline       
Injections alone vs Jawline and Cheek Injections  
 
                                               Blinded Physician Assessment 
 
Patient Number________   Date: __________ 
 
Baseline or Date post 1st Injection: Baseline____ 4w_____ 8w_____ 12 week____ 16 week__ 
Baseline or Date Post 2nd Injection: Baseline____4w_____ 8w_____12 week___ 16 week ___ 
 
 Grading of Jowls Instructions: Without referring to previous photographs and using the Grading scale 
pictured above, put an X by the value you feel represents the appearance of this patient today.   
 
    1______   2______   3______   4______    5______ 
 
 
Grading of Jowls by photographic assessment of before and after photos:  Reviewing the photographs of 
the patient prior to injection and the photograph of the patient today, please evaluate the subjects 
(dis)improvement by putting an X by the value you feel represents the change in these photographs.  
 
             Much improved___ 
         
Improved____ 
         
No change____ 
         
Worse____ 
         
Much Worse ______ 
 
Comments:__________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________ 
  
 
Blinded Physician: Name_______________________Signature____________________ 
Date:____________________________ 

 Jowl Improvement with Injectable Fillers: Jawline 
Injections alone vs Jawline and Cheek Injections 10001 
Subject Self-Assessment of Results 
Patient Number________ 
 
Date: __________ 
 
Baseline or Date post 1st Injection:     Baseline______ 4 w____ 8w_____ 12 w_____16 week___ 
Or: 
Date Post 2nd Injection: Baseline       4 w______ 8w_____ 12 w_____16 week___ 
 
 
Grading of Jowls Instructions: Without referring to previous photographs and using the Grading scale 
pictured above, put an X by the value you feel represents the appearance of your jowls/jawline today.   
 
    1______   2______   3______   4______    5______ 
 
Grading of Jowls by photographic assessment of before and after photos:  Reviewing the photographs of 
yourself prior to injection and the photograph of yourself today, please evaluate your (dis)improvement by 
putting an X by the value you feel represents the change in these photographs.  
 
             Much improved___ 
         
Improved____ 
         
No change____ 
         
Worse____ 
         
Much Worse ______ 
 
Comments:__________________________________________________________________________
____________________________________________________________________________________ 
  
 
Signature of Coordinator___________________Date: ____________________________ 

Voluma Jowl/Jawline Study 10001-Patient Diary 
Patient Number_____________________                                            Date_______________________ 
Days since treatment________________ 
Please Complete all of the following questions daily. Record your patient number, the date, and how 
many days it has been since treatment above. For the questions which require to answer mild, 
moderate, or severe, please follow these guidelines:  
• 
Mild: mild symptoms; clinical or diagnostic observations only; no intervention needed 
• 
Moderate: minimal, and/or local or noninvasive intervention needed 
• 
Severe: significant but not immediately life threatening; hospitalization or prolongation of 
hospitalization needed 
Have you experienced any of the following symptoms? 
• 
Moderate to Severe Dizziness                                               YES______    NO______   
If yes was it Mild_________  Moderate__________ Severe______________ 
 
• 
Confusion                                                                                  YES______    NO______ 
If yes was it Mild_________  Moderate__________ Severe______________ 
 
• 
Weakness or numbness in your arms or legs                     YES______    NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
• 
Changes to consciousness or alertness                               YES______    NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
• 
Difficulty speaking/ speech impairment                             YES______    NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
• 
Facial droop                                                                               YES______    NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
***If you have answered yes to any of the above questions, please 
dial 911 and seek immediate medical attention.  
• 
 Changes in vision (i.e. loss of vision, blurriness, double vision, pain in or around your eye, blindness, blind 
spots, problems moving your eyes)                                     YES______    NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
• 
Skin changing color on any portion of the face?                YES______    NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
 
• 
Crusty or scabby skin around the eyelids or any other area of the face 
  YES______    NO______ 
             If yes was it  Mild_________  Moderate__________ Severe______________ 
 

• 
Moderate to Severe Pain in any area?                                YES______    NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
 
• 
Moderate to Severe Headache                                             YES______    NO______    
 If yes was it  Mild_________  Moderate__________ Severe______________ 
                                    
• 
Fever                                                                                          YES______    NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
• 
Difficulty Chewing or Swallowing                                         YES_______   NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
• 
Moderate to Severe Pain in Jaw at Rest                               YES_______   NO______ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
**If you have answered yes to any of the above questions, please call 
the office immediately at 847-459-6400 during business hours, or Dr 
Taub at 847-772-8180 if after hours  
 
These questions will track any adverse events that may occur. Please let us know if you have had 
any of the following: 
 
1. Have you noticed any other symptoms not listed above?             Yes_____ No________ 
If yes, list symptoms______________________________________________________ 
_______________________________________________________________________ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
2. Have you had any continuing symptoms since your last diary?    Yes______ No_______ 
If yes, please list__________________________________________________________ 
_______________________________________________________________________ 
3. Have any symptoms/side effects subsided since last diary?          Yes_______ No_______ 
If yes, please list___________________________________________________________ 
________________________________________________________________________ 
4. Any change in medications, including over the counter medications since your last visit or diary?              
Yes_____ No________ 
If yes, list medications_____________________________________________________ 
________________________________________________________________________ 
5. Have you been diagnosed with any new medical conditions since your last visit or diary? 
Yes_____ No_______ If yes, please list________________________________________ 
_______________________________________________________________________ 
6. Have you had any illnesses since your last visit or diary?               Yes_____ No_________ 
If yes, list illness___________________________________________________________ 
_________________________________________________________________________ 
7. Have you undergone any surgeries since your last visit or diary?   Yes____ No_________ 
If yes, list surgeries_________________________________________________________ 

________________________________________________________________________ 
 
8. Please rate your pain on the pain scale: 
 
9. Are you experiencing any of the following today: 
 
Bruising                                                                         Yes_________ No____________ 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
Redness 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
Firmness 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
Lumps/Bumps 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
Itching 
If yes was it  Mild_________  Moderate__________ Severe______________ 
 
 Do you feel comfortable going out in public today?  Yes_______  No_________ 
If not, why not?___________________________________________________________________ 
 
Any other observations or comment you have?___________________________________________ 
_________________________________________________________________________________ 
 
                                                 
 
 
 
 
 
 
 
 

 
 
Jowl Improvement with Injectable Fillers: 
Jawline Injections alone vs Jawline and  
Cheek Injections-Operative Note 
 
 
Subject #  ________    Date___________ 
Start Time of Injection_______ Stop Time of Injection_______ 
Lot # Voluma _____________ Expiration Date Voluma ___________ 
 
This form is to be completed at the time of injection.  Areas injected will be represented by hand drawing 
on the diagram by the injector indicating the below labels (A1-D2).  The amount (cc) placed in each area 
represented by the labels below injected will be written into the boxes below by the injector and the depth 
of injection as abbreviated herein will be circled. 
Depth of Injection: P=Periosteal, SC=Subcutaneous 
 
 
 
A1:     ____ ___cc 
P         SC (circle one both) 
 
A2:     ____ ___cc 
P         SC (circle one both) 
 
 
B1:     ____ ___cc 
P         SC (circle one both) 
 
B2:     ____ ___cc 
P         SC (circle one both) 
 
C1:     ____ ___cc 
P         SC (circle one both) 
 
C2:     ____ ___cc 
P         SC (circle one both) 
 
D1:     ____ ___cc 
P         SC (circle one both) 
 
D2:     ____ ___cc 
P         SC (circle one both) 
 
 
 
Signature__________________________   Date _____________ 
               Amy Forman Taub, MD 

Cranial Nerve Evaluations CRF 
Subject Number: ________                       Date: ________  
 
Visit Type:________ 
 
Cranial Nerves II-VII; IX, X, XII Evaluation Criteria 
Cranial 
Nerve 
Nerve Name 
Function 
Test 
II 
III 
Optic Nerve 
Oculomotor Nerve 
Pupillary 
reaction to 
light and 
accommodati
on 
Tell the subject to look into the distance. Shine a bright light obliquely into each pupil. 
Look for: 
• Direct light reflex – Pupillary constriction in the same eye. 
• Consensual reaction – Pupillary constriction in the opposite eye. 
• Accommodation – move the penlight toward the nose and observe pupillary 
constriction. 
III 
IV 
VI 
Oculomotor Nerve 
Trochlear Nerve 
Abducens Nerve 
Extraocular 
movements 
Stand two feet directly in front of subject. Use your finger to make a horizontal sweep 
from the subject’s left to the right at the level of the subject’s eyes. Repeat this 
horizontal sweep at the level of the forehead and the chin. Look for normal conjugate 
movement of the eyes in each direction or any deviation from normal. A few beats of 
nystagmus on far lateral gaze is normal. 
V 
Trigeminal Nerve 
Motor 
Ask the subject to clench their teeth. Palpate the temporal and masseter muscles and 
note strength of muscle contraction. 
Gross 
sensation 
Tell subject to close their eyes. Using a cotton swab stick or similar object, touch the 
subject’s forehead, cheeks and jaw with the dull cotton end and the sharper wooden 
end in random fashion. Ask the subject to say if they feel the object is dull or sharp. 
Compare sensation on both sides of the face. 
VII 
Facial Nerve 
Motor 
The Regional House-Brackmann Facial Nerve Grading System will be used to evaluate 
the facial nerve branches at rest and during conversation with the subject. Ask the 
subject to: 
• Raise both eyebrows 
• Frown 
• Close both eyes tightly while Investigator tries to open eye lids 
• Show both upper and lower teeth 
• Smile 
• Puff out both cheeks 
IX 
Glossopharyngeal  
Nerve 
Vagus Nerve 
Gagging, 
swallowing 
(gross 
sensation and 
motor); 
Speech  
Ask subject to swallow while palpating front of the neck. Subject should have no issues 
or discomfort when swallowing.  
(Assess gag reflex if patient reports changes from baseline and if there is reason to 
suspect related pathology).  
Ask subject to say “Ahhh”. The uvula should elevate symmetrically as a normal 
response. Subject should have no difficulty or impairments when speaking. Note if 
hoarseness is present. 
 
X 
XII 
Hypoglossal 
Tongue 
Movement 
(Motor) 
Ask patient to stick their tongue out and have them move side to side, from cheek to 
cheek. Tongue movements should be symmetrical.  
 
 
ASSESSMENT OF CRANIAL NERVES II-VII; IX, X, XII 

 
Subject Number: ________                       Date: ________  
 
Visit Type:________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subject Number: ________                       Date: ________  
 
Visit Type:________ 
 Rating/Description 
 1 = Normal 
 2 = Abnormal, not clinically     
significant 
 
 3 = Abnormal, clinically significant 
 4 = Not assessed 
Cranial 
Nerve # 
Nerve 
Function 
Result 
Score each side for each nerve function 
Right Side of Face 
Left Side of Face 
II 
OPTIC 
Pupillary Reaction to Light 
and Accommodation 
 
 
III 
OCULOMOTOR 
III 
OCULOMOTOR 
Extraocular Movements 
 
 
IV 
TROCHLEAR 
VI 
ABDUCENS 
V 
TRIGEMINAL 
Motor 
 
 
V 
TRIGEMINAL 
Gross Sensation 
 
 
VII 
FACIAL 
Motor 
Complete Regional House-Brackmann Facial 
Nerve Grading System
IX 
GLOSSOPHARYNGEAL 
Gross Sensation and Motor 
 
 
X 
VAGUS 
Gross Sensation and Motor 
 
 
XII 
HYPOGLOSSAL 
Motor 
 
 

 
REGIONAL HOUSE-BRACKMANN FACIAL NERVE GRADING SYSTEM 
VII - Facial Nerve Assessment (Motor function)  
Region and Score Description 
Score each side of face 
for each region 
Right 
Side of Face 
Left 
Side of Face 
Forehead 
1 = Normal forehead movement 
2 = Slight weakness in forehead movement 
3 = Obvious but not disfiguring asymmetry with motion, symmetric at rest 
4 = Obvious weakness of disfiguring asymmetry with motion, symmetric at rest 
5 = Barely perceptible motion in forehead, asymmetric at rest 
6 = No movement 
 
 
 
 
 
 
 
 
 
Eye 
1 = Normal eye closure 
2 = Mild weakness in eye closure 
3 = Obvious weakness but able to close eyes 
4 = Unable to close eye with maximal effort 
5 = Barely perceptible eyelid movement 
6 = No movement 
 
 
 
 
 
 
 
 
Midface 
1 = Normal midface movement 
2 = Slight weakness in midface movement 
3 = Obvious but not disfiguring weakness, symmetric at rest 
4 = Obvious weakness and disfiguring asymmetry with motion, symmetric at rest 
5 = Barely perceptible motion in midface, asymmetric at rest  
6 = No movement 
 
 
Mouth 
1 = Normal corner of mouth movement 
2 = Slight weakness of corner of mouth movement 
3 = Obvious but not disfiguring weakness, symmetric at rest 
4 = Obvious weakness and disfiguring asymmetry with motion, symmetric at rest 
5 = Barely perceptible corner of mouth movement, asymmetric at rest 
6 = No movement 
 
 
Synkinesis  
(voluntary muscle movement causing the simultaneous involuntary contraction of other 
muscles)  
1 = None 
2 = Mild - obvious but not disfiguring 
3 = Severe - disfiguring or interferes with function  
 
 
 

Safety Eye Exams 
 
1.  Snellen Visual Exam: 
 
RIGHT EYE:      20/10____    20/15____    20/20____     
                             20/25____    20/30____    20/40____                             TIME:__________   
 
 
 
 
 LEFT EYE:       20/10____    20/15____    20/20____     
                             20/25____    20/30____    20/40____                             TIME:__________    
 
  
2. Ocular Motility Exam: 
 
RIGHT EYE:                                                                                              TIME:__________    
Elevation Central:                            Normal____ Abnormal___     
Elevation Upper Lateral Quadrant:  Normal____ Abnormal____ 
Elevation Upper Medial Quadrant:  Normal____ Abnormal  
Depression Central:                          Normal ____Abnormal_____ 
Depression Inferior Lateral:             Normal____ Abnormal_____ 
Depression Inferior Medial:             Normal ____ Abnormal____ 
Change from Previous Exam:          Yes______      No______         
 
                                            
 
LEFT EYE:                                                                                                 TIME:__________    
Elevation Central:                            Normal____ Abnormal___     
Elevation Upper Lateral Quadrant:  Normal____ Abnormal____ 
Elevation Upper Medial Quadrant:  Normal____ Abnormal  
Depression Central:                          Normal ____Abnormal_____ 
Depression Inferior Lateral:             Normal____ Abnormal_____ 
Depression Inferior Medial:             Normal ____ Abnormal____ 
Change from Previous Exam:          Yes______      No______                 
 
 
 
3.  Confrontational Visual Fields Exam: 
 
RIGHT EYE:                                                                                               TIME:___________ 
           Right upper outer quadrant:     Normal______       Abnormal______ 
           Right lower outer quadrant:     Normal______       Abnormal______ 
           Right inner outer quadrant:      Normal______       Abnormal______ 
           Right inner outer quadrant:      Normal_______     Abnormal______ 
          Change from Previous Exam:   Yes______      No______                                    
 
                        
 
LEFT EYE:                                                                                                  TIME:___________ 
           Right upper outer quadrant:     Normal______       Abnormal______ 
           Right lower outer quadrant:     Normal______       Abnormal______ 
           Right inner outer quadrant:      Normal______       Abnormal______ 
           Right inner outer quadrant:      Normal_______     Abnormal______ 
          Change from Previous Exam:   Yes______      No______                                
                            
 
 
 

Physical and Visual Exam 
 
 
 
Visual Evaluation: 
Is Any Drooping of the Face Observed                                              Yes_____________    No_____________ 
Is There Any Change in Skin Color Around the Eyelids                 Yes_____________     No____________ 
Is there any Crusty or Scabby Skin Around the Eyelids                  Yes_____________    No____________ 
Any Other Observations or Notes                                                       Yes_____________    No_____________ 
_________________________________________________________________________________________ 
_________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
_________________________________________________________________________________________ 
 
 
 
Was Evaluation of Neurological Function Completed                      Yes_____________     No_____________ 
Notes:____________________________________________________________________________________ 
__________________________________________________________________________________________ 
__________________________________________________________________________________________ 
__________________________________________________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
TMJ Exam 
TMJ examination begins with palpation of the muscles in the face and neck regions. 
 
Palpation of the Right masseter muscle: 
• 
Pain:       Yes_____ No_____      Explain_______________________________________________ 
• 
Masses:  Yes_____ No_____       
Palpation of the Left masseter muscle: 
• 
Pain:       Yes_____ No_____      Explain_______________________________________________ 
• 
Masses:  Yes_____ No_____      
 
1. Patient open and close mouth:                                                         Yes_____ No_____ 
2. Normal range of motion:                                                                  Yes_____   No______ 
3. Pain with opening or closing mouth:                                               Yes______ No______        
Explain__________________________________________________________________________ 
_________________________________________________________________________________ 
4. Any reported problems with chewing or swallowing:                    Yes_____ No_____ 
5. Any pain with chewing?                                                                    Yes______ No______        
Explain___________________________________________________________________________ 
             _________________________________________________________________________________ 
 
Any other observation?                                                                      Yes______ No______ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________ 
________________________________________________________________________________________
 

PAIN ASSESSMENT FORM CRF 
 
Subject 
 
 
Date: 
      
1. 
Are you experiencing any pain today? Yes____   No_____   * If yes please answer the following questions. 
2. 
Where is your paint located? 
 
3. 
When did your pain begin? 
 
4. 
Does the pain radiate or travel to other areas? 
 
5. 
Is your pain: (please check answer) ο Intermittent ο Continuous ο Both? 
6. 
 Does your pain vary in intensity? ο Yes ο No 
7. 
Rate the intensity of your pain: 
 
8. 
How does your pain affect your lifestyle? (↑, ↓ , no change) 
Choose 
 Sleep? 
 Appetite? 
 Activity? 
 Energy? 
Are you 
experiencing 
any other 
symptoms? 
Nausea 
Yes 
No 
Sleepiness 
Yes 
No 
Weakness 
Vomiting 
Confusion 
Itching 
 
 
 
Additional Notes: 
 

 
 
 
 
 
Hyaluronic Acid 
 
POST-TREATMENT INSTRUCTIONS 
 
 
• 
Immediately after the treatment, there may be redness, swelling, tenderness, bruising and an 
itching sensation in the treated area. This is a normal result of the injections.  The 
inconvenience is temporary and generally disappears within a few days.  If the inconvenience 
continues or, if other reactions occur, please contact the office. 
 
• 
Some patients experience swelling for about a week and can look somewhat uneven during 
this time. This means that the result directly after the treatment should not been seen as the 
final result. Cool compresses or ice packs for 48 hours may help to reduce swelling. Bruising 
in all treated areas may last up to 2 weeks. 
 
• 
Avoid excessive sun and UV lamp exposure until any initial swelling and redness have 
resolved.   
 
• 
The treated areas may be washed with soap and water. If required, light makeup may be 
applied with clean fingers following treatment. 
 
• 
Until the initial swelling and redness have resolved, do not expose the treated area to intense 
heat (e.g. sauna and sunbathing) or extreme cold. 
 
• 
If you have previously suffered from facial cold sores, there is a risk that the needle punctures 
could contribute to another eruption of cold sores. Please tell your provider if you have a 
history of cold sores. 
 
• 
If you are using aspirin or any similar medication, be aware that these may increase the 
bruising and bleeding at the injection site. If pain medication is necessary, please use Tylenol 
(acetaminophen). 
 
• 
In a study to evaluate Voluma for injection of the cheeks, the average duration for the 
majority of patients was  up to 2 years, but not every patient achieved this duration. This 
study of  of Voluma in the jawline and cheeks is not intended to study duration of effect.  After 
the effect of the injection wears off (estimate from 6 months to 2 years), you would have to be 
reinjected outside of the study to reestablish effect.  To properly evaluation the safety in this 
study, you would not be eligible for reinjection until 12 months after your last study injection.   
• 
Complete Patient diary daily for 30 days following treatment. 
 
• 
If you experience any side effects or unusual symptoms, or have any other questions or 
concerns, please contact the office immediately at: 847-459-6400.    

 
 
 
 
 
 
Photography Release Consent Form 
 
I, ___________________________________, hereby authorize Advanced Dermatology to 
release the photograph(s) obtained during my participation in the Jowl/Jawline Voluma Study 
 
This authorizes Advanced Dermatology to use the photographs listed below in promotional or 
educational materials. These materials might include printed or electronic publications, websites 
or other electronic communications/presentations. These images may be used indefinitely 
without compensation to the owner. I understand that my name will not be released.     
 
For internal use: (dates of photos) 
Baseline: 
 
_____ / _____ / _____ 
 
2-week Follow-up: 
_____ / _____ / _____ 
 
4-week Follow-up: 
_____ / _____ / _____ 
 
8-week follow-up:          _____ / _____ / _____ 
 
I consent to the release of photos.   
Patient: 
 
_________________________________ 
______________________________________ 
Print Name 
 
 
 
 
Signature 
 
________________________________  
______________________________________  
Today’s Date 
 
 
 
 
Date of Birth 
 
Witness: 
________________________________             _______________________________________ 
Print Name 
 
 
 
 
Signature 
 
________________________________ 
Today’s Date 
 
 
 
 
 
Medical Director: 
 
 
________________________________  
______________________________________ 
Amy Forman Taub, MD  
 
 
Today’s Date 
 
 

 
DOCUMENTATION OF CONSENT PROCESS 
 
 
Subject Name: __________________________________________      Time Obtained:_______________ 
 
Person obtaining consent to initial each completed step in the process: 
 
____ Informed consent was discussed with subject for the above referenced study. Copy of the consent form 
was provided for subject (in a language understandable to the patient) and/or authorized subject 
representative review. 
 
 
 
____ Subject and/or authorized subject representative was given adequate time to read the consent form and 
discuss the study with study investigators and/or family members.  
 
____ All questions were answered. Subject and/or authorized subject representative was given time to  
discuss. 
 
____ Subject and/or authorized subject representative signed and dated the informed consent. A copy of the 
consent form was provided to the subject and/or authorized subject representative upon conclusion of 
the consent process. 
 
____    HIPAA form was reviewed with subject. Informed Consent process was conducted in a manner and  
location that ensured patient privacy. 
 
____ During informed consent process, the following questions were asked by the subject and/or authorized 
representative and were answered by study personnel: 
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
 
_____ Consent has been signed prior to any study procedures being performed. 
 
Consent process documented by: ____________________________             
 
 
                   
     Print Name 
 
       
 
 
                ______________________________ 
    __________ 
                                                     Signature   
 
 
 
    Date 
 
 
Consent process verified by:     ____________________________ 
 
 
                   
     Print Name 
 
       
 
 
                ______________________________ 
    __________ 
                                                     Signature 
   Date