A Randomized, Split-face Clinical Study on Comparative Ultrasound Analysis of Two Hyaluronic Acid Fillers for Midface Correction
Phase: NA
Conditions: Volume Deficiency of the Midface
Sponsor: Galderma R&D

 
 
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Protocol Version 2: 19 October, 2022 
 
 
 
Title 
A randomized, split-face clinical study on comparative 
ultrasound analysis of two Hyaluronic Acid fillers for midface 
correction 
Protocol number: 
GLI.04.US.SL.015 
Sponsor name and 
address: 
Galderma Laboratories, L.P. 
14501 North Freeway 
Fort Worth, TX 76177 
USA 
Test products: 
Restylane® Contour 
Juvéderm® Voluma® 
Investigator agreement: I have read the clinical study described herein, recognize its 
confidentiality, and agree to conduct the described study in 
compliance with Good Clinical Practices (GCP), the ethical 
principles contained within the Declaration of Helsinki, this 
protocol, and all applicable regulatory requirements. 
Principle Investigator: 
 
 
 
Signature 
 
 
 
 
Date 
Name: 
Steve F. Weiner, MD 
Address: 
The Aesthetic Clinique 
2050 West County Highway 30A Suite 114 
Santa Rosa Beach, FL 32459 
USA 
Telephone: 1-850-600-6997 

 
 
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A RANDOMIZED, SPLIT-FACE CLINICAL STUDY ON COMPARATIVE ULTRASOUND 
ANALYSIS OF TWO HYALURONIC ACID FILLERS FOR MIDFACE CORRECTION 
 
APPROVAL SIGNATURE PAGE 
 
 
_________________________________________  
 
_______________ 
Steven F. Weiner, MD 
 
 
 
 
 
Date 
Principle Investigator 
The Aesthetic Clinique 
 
 
_________________________________________  
 
_______________ 
Jessica Hicks, PhD 
 
 
 
 
 
 
Date 
Senior Medical Affair Advisor 
Galderma Laboratories, L.P. 
 
 
_________________________________________  
 
_______________ 
Matthew Meckfessel, PhD 
 
 
 
 
 
Date 
Director, Medical Affairs 
Galderma Laboratories, L.P. 
 
 

 
 
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1. 
SYNOPSIS 
Study Objective 
To assess and compare tissue aggregation and visualization of 
two (2) Hyaluronic Acid fillers via ultrasound 
Methodology 
Randomized, split-face, subject-blinded, comparative study 
Number of Subjects at the 
end 
15 subjects to complete 
Study duration 
24 weeks 
Test products 
Restylane Contour 
Juvéderm Voluma 
Conditions of use 
Per on-label instruction 
Study visits 
Day 0, week 4, and week 24 
Specific Inclusion Criteria: 
o Demographics and study skin conditions 
- Any race and ethnicity (to be recorded) 
- Fitzpatrick skin type (to be recorded) 
- Women or men  
- Age: 22 to 65 years old 
- Subject with midface volume loss and contour deficiency 
 
o Administrative 
- Ability of giving consent for participation in the study  
- Agreement to adhere to the procedures and requirements of the 
study and to report to the institute on the day(s) and at the time(s) 
scheduled for the assessments. 
Specific Exclusion 
Criteria: 
o Skin conditions 
- History of allergy or hypersensitivity to lidocaine and/or injectable 
hyaluronic acid (HA) 
- Previous permanent or semi-permanent implant in proposed 
treatment area 
- Previous biodegradable tissue augmentation therapy in the 
proposed treatment area within 12 months prior to the baseline 
visit 

 
 
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- History of other facial treatment/procedure at the study area 
(midface) in the previous 6 months that would potentially interfere 
with study injections (e.g., facial surgery, oral surgery, resurfacing, 
mesotherapy, lipolytic injections, botulinum toxin injections) 
Procedure 
o D0 
- Subjects will report to the site as D0 visit, will be given an 
informed consent form, HIPAA form, photography release form, 
Code of Conduct form, and medical history form to complete. 
- Subjects will be screened on the basis of the selection criteria for 
study qualification. 
- Ultrasound will be performed on enrolled subject’s cheeks, left 
and right side will be assessed separately.  
- 2D photography will be performed at neutral expression (3/4 left, 
front, 3/4 right) and at smiling (3/4 left, front 3/4 right). 3D 
photography will be performed at neutral expression on entire face. 
- Investigator will perform injection to the subjects, based on the 
predetermined randomization and the test products’ instruction to 
achieve the maximum correction.  
- Immediately post-injection, ultrasound will be performed at the 
same location of the injection, on either side of the face. 
o W4 
- Subjects to return to the site at week 4 post-treatment (± 3 days).  
- Ultrasound, 2D and 3D photography will be performed similarly to 
D0. 
- Self-assessment questionnaire will be performed by the subjects. 
- If needed, subjects will be offered a touch up to correct uneven 
side upon study completion. 
o W24 
- Subjects to return to the site at week 24 post-treatment (± 3 
days).  
- Ultrasound, 2D and 3D photography will be performed similarly to 
D0. 
- Self-assessment questionnaire will be performed by the subjects. 
Statistical analysis 
Comparison of filler aggregation, volume change, and self-
assessment questionnaire. 
 
 

 
 
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2. 
TABLE OF CONTENTS 
 
1. 
SYNOPSIS ......................................................................................................................... 3 
2. 
TABLE OF CONTENTS ..................................................................................................... 5 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................. 7 
4. 
BACKGROUND AND RATIONALE .................................................................................... 8 
5. 
STUDY OBJECTIVE AND CLINICAL HYPOTHESIS ......................................................... 8 
5.1 
Study Objective ............................................................................................................ 8 
5.2 
Clinical Hypothesis ....................................................................................................... 8 
6. 
SELECTION AND DISPOSITION OF STUDY POPULATION ............................................ 8 
6.1 
Number of Subjects ..................................................................................................... 8 
6.2 
Study Population Characteristics ................................................................................. 8 
6.3 
Inclusion Criteria .......................................................................................................... 8 
6.4 
Exclusion Criteria ......................................................................................................... 9 
6.5 
Concomitant Therapies ................................................................................................ 9 
6.5.1. 
Authorized Therapies ............................................................................................ 9 
6.5.2. 
Prohibited Therapies ............................................................................................. 9 
7. 
STUDY TREATMENT .......................................................................................................10 
7.1 
Product Identification and Use ....................................................................................10 
7.2 
Additional Products and Materials ...............................................................................10 
7.3 
Study Product Accountability ......................................................................................11 
7.4 
Method of Treatment Assignment ...............................................................................11 
7.5 
Treatments Administered ............................................................................................11 
8. 
STUDY PROCEDURES ....................................................................................................12 
8.1 
Visits and Examinations ..............................................................................................13 
8.1.1. 
Screening/Baseline/Day 0 Visit (Visit 1) ...............................................................13 
8.1.2. 
Visit 2 (Week 4 or Day 28 ±3 days) ......................................................................14 
8.1.3. 
Visit 3 (Week 24 or Day 168 ±3 days) ..................................................................14 
8.2 
Discontinued Subjects ................................................................................................14 
9. 
STUDY ASSESSMENTS ..................................................................................................15 
9.1 
Clinical Photography (VISIA) .......................................................................................15 
9.2 
Clinical Photography (Vectra 3D) ................................................................................15 
9.3 
Ultrasound ..................................................................................................................16 
9.4 
Self-Assessment Questionnaire ..................................................................................16 
10. 
STATISTICAL ANALYSIS ..............................................................................................16 

 
 
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11. 
ADVERSE EVENTS .......................................................................................................17 
11.1 
Definitions ...............................................................................................................17 
11.1.1. 
Adverse Events (AE) ......................................................................................17 
11.1.2. 
Local tolerability signs and symptoms (only applicable for cosmetic safety 
studies) 
17 
11.1.3. 
Serious Adverse Events (SAE) and serious undesirable effect/related SAE ...18 
11.2 
Severity Assessment ...............................................................................................18 
11.3 
Causality Assessment .............................................................................................18 
11.4 
Collection, Management and Reporting Procedures ................................................19 
11.4.1. 
Management and reporting procedures for undesirable effects (i.e. related 
adverse events ..................................................................................................................19 
11.4.2. 
Management and reporting procedures for Serious Adverse Events ..............19 
11.5 
Pregnancy ...............................................................................................................20 
11.6 
Process for Suspected Allergic Reactions ................. Error! Bookmark not defined. 
12. 
ETHICAL AND REGULATORY PROCEDURES ............................................................20 
12.1 
Research Standards/Good Clinical Practice ............................................................20 
12.2 
Quality Assurance/Audit/Inspection .........................................................................20 
12.3 
Institutional Review Board .......................................................................................21 
13. 
STUDY CONDUCT CONDISERATIONS ........................................................................21 
13.1 
Clinical Monitoring ...................................................................................................21 
13.2 
Data Collection ........................................................................................................21 
13.3 
Record Retention ....................................................................................................22 
13.4 
Changes in Study Conduct/Amendments ................................................................22 
13.5 
Confidentiality ..........................................................................................................22 
14. 
REFERENCES ...............................................................................................................22 
APPENDIX I: SELF-ASSESSMENT QUESTIONNAIRE ...........................................................24 
 
 
 
 
 

 
 
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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE  
Adverse Event 
°C 
Degrees Celsius 
CRF 
Case Report Form 
etc. 
et cetera 
e.g.  
for example (Latin; exempla gratia) 
°F 
Degrees Fahrenheit 
GCP 
Good Clinical Practice 
HA 
Hyaluronic Acid 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
International Conference on Harmonization  
ICT 
Information and communication technologies 
i.e. 
that is (Latin; id est) 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
N or n 
Number 
% 
percent 
SAE 
Serious Adverse Event 
SD 
Standard deviation 
SOP 
Standard Operating Procedure 
 

 
 
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4. 
BACKGROUND AND RATIONALE 
The hallmark signs of aging in the mid-face are often characterized by the decrease in skin 
elasticity and thickness, loss of tissue volume and body mass, and redistribution of fat tissues. 
Overtime, they result in the formation of deep wrinkles, folds, sagging skin, and hollowing.1 One 
of the most popular non-invasive aesthetic treatments for mid-face volume restoration is the use 
of hyaluronic acid (HA) fillers. Due to their safety, effectiveness, and reversibility by hyaluronidase, 
HA fillers can help correct facial wrinkles and folds, while improving facial contour and volume 
augmentation.1-3 
Currently in the market, there are various types of HA fillers have been approved for the midface 
volume restoration. Among them are two well-known fillers: Restylane® Contour (Galderma, 
Uppsala, Sweden) and Juvéderm® Voluma® (AbbVie/Allergan Aesthetics, Irvine, CA). They each 
contain 20mg/mL of hyaluronic acid with different crosslinking gel technologies, resulting in 
varying biophysical properties. Restylane® Contour has moderate lifting capacity (G’) and 
flexibility whereas Juvéderm® Voluma® has a higher lifting capacity (G’) and low flexibility.  
The mechanism that each HA filler integrates into the skin tissue reflects the overall appearance 
of the midface. This study is to investigate how the two HA fillers behave in the skin tissue using 
ultrasound.  
5. 
STUDY OBJECTIVE AND CLINICAL HYPOTHESIS 
5.1 
Study Objective  
To assess and compare tissue aggregation and visualization of two Hyaluronic Acid 
fillers via ultrasound.   
5.2 
Clinical Hypothesis 
When each HA filler is injected and integrated into the tissue, it will add volume to the skin 
to achieve different lifting and contouring effect. 
6. 
SELECTION AND DISPOSITION OF STUDY POPULATION 
6.1 
Number of Subjects 
A minimum 15 subjects meeting inclusion/exclusion criteria listed below will be enrolled on the 
study to achieve 15 subjects who complete the study as planned.  
6.2 
Study Population Characteristics 
Males and females of any skin type with diagnosis of midface volume loss and contour 
deficiency.   
6.3 
Inclusion Criteria 
1. Subjects of 22 to 65 years of age. 
2. Subjects with a clinical diagnosis of midface volume loss and contour deficiency, and in 
the opinion of the investigator, is otherwise a good candidate for treatment with HA 
fillers.  
3. Subjects of any gender. 
4. Subjects of any race and ethnicity. 

 
 
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5. Subjects of any Fitzpatrick skin type. 
6. Subjects who are able and willing to provide written informed consent prior to any study 
related procedures.  
7. Subjects who agree to be photographed at each visit. 
8. Subjects apprised of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA) and applicable state Bill of Rights. 
9. Subjects who agree to adhere to the procedures and requirements of the study, to report 
to the institute on the day(s) and at the time(s) scheduled for the assessments, and to 
complete all required visits. 
6.4 
Exclusion Criteria 
1. Subjects with any diseases, condition or presentation that may, in the opinion of the 
investigator, may put the subject at risk, may confound study results, or may interfere 
with participation in the study.  
2. Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast 
feed during the course of the trial. 
3. Subjects that are relatives of the investigator or are themselves or a relative of any study 
staff or any Galderma employee.  
4. Subjects who have participated in an investigational study within 30 days of enrollment; 
participated in biologic investigational studies within 90 days of enrollment, or subjects 
planning to participate in any other interventional clinical research study while enrolled in 
this trial.  
5. Subjects with history of allergy or hypersensitivity to lidocaine and/or injectable HA 
6. Subjects with previous permanent or semi-permanent implant in proposed treatment 
area 
7. Subjects with previous biodegradable tissue augmentation therapy in the proposed 
treatment area within 12 months prior to the baseline visit 
8. Subjects with history of other facial treatment/procedure at the study area (midface) in 
the previous 6 months that would potentially interfere with study injections (e.g., facial 
surgery, oral surgery, resurfacing, mesotherapy, lipolytic injections, botulinum toxin 
injections). 
9. Use of concomitant medications that have the potential to prolong bleeding times such 
as anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other nonsteroidal 
anti-inflammatory drugs, Omega 3 or Vitamin E), within 14 days prior to injection. Omega 
3 and Vitamin E were acceptable only as part of a standard multivitamin formulation. 
6.5 
Concomitant Therapies 
All treatments and therapies used 30 days prior to enrollment (visit 1/baseline) or 90 days prior 
to enrollment for biologics and all treatments or therapies used during the course of the study 
must be recorded in the Case Report Form (CRF) or electronic Case Report Form (eCRF). 
6.5.1. Authorized Therapies 
Unless listed under the exclusion criteria (Section 6.4) or in Prohibited Therapies (Section 
6.5.2), other therapies to treat ongoing conditions are authorized. 
6.5.2. Prohibited Therapies 
None other than as specified in the Inclusion/Exclusion criteria.  

 
 
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The decision to administer a prohibited medication/treatment should be made with the safety of 
the subject being the primary consideration. Whenever possible, Galderma Laboratories, L.P. 
should be notified before the prohibited medication/treatment is administered to discuss 
possible alternatives. 
If a subject receives prohibited therapy during the study, the subject may be allowed (at the 
discretion of the investigator / Galderma Laboratories, L.P.) to continue in the study for safety 
evaluation purposes, only. 
7. 
STUDY TREATMENT 
The term “study treatment” refers to the study products (HA Fillers, see Section 7.1) 
7.1 
Product Identification and Use 
Study product: Restylane® Contour 
Form 
Transparent gel of HA with the addition of lidocaine 
hydrochloride 3 mg/mL 
Mode of Administration 
Injection 
How supplied 
Pre-filled plastic syringes containing 1 mL of gel. 
Each syringe is co-packed with two ultra-thin wall 
needles.  
Lot numbers 
19741 
Storage and Handling 
The syringes are to be stored in the original packaging, 
under controlled room temperature conditions 20°C to 
25°C (68°F to 77°F), protected from freezing and 
sunlight. 
 
Study product: Juvéderm® Voluma® 
Form 
Sterile, biodegradable, non-pyrogenic, viscoelastic, 
clear, colorless, homogenous gel implant of HA 
crosslinked with BDDE, formulated to a concentration of 
20 mg/mL and 0.3% w/w lidocaine in a physiologic 
buffer. 
Mode of Administration 
Injection 
How supplied 
Individual treatment syringes with needles. 
Lot numbers 
VB20B20024 
Storage and Handling 
Store at room temperature (up to 25°C/77°F). DO NOT 
FREEZE. 
 
7.2 
Additional Products and Materials 
The Sponsor will only provide Restylane® Contour for the study. The study overhead will cover 
any additional materials or supplies.  

 
 
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7.3 
Study Product Accountability 
Upon receipt of the study products, the investigator or designee will conduct an inventory. In 
accordance with federal regulations, the investigator must agree to keep all test article in a 
secure location with restricted access. Designated study personnel will provide the test article to 
the subjects in accordance with the protocol.  
During the study, the investigator must maintain records of study treatment dispensation and 
collection for each subject. This record must be made available to the study monitor for the 
purposes of verifying the accounting of clinical supplies. Any discrepancies and/or deficiencies 
between the observed disposition and the written account must be recorded along with an 
explanation. At the conclusion of the study, the investigator will be responsible for returning all 
unused study product (i.e., Restylane® Contour) unless otherwise instructed by the Sponsor. 
Shipping label and cost will be provided to the investigator by the Sponsor. 
7.4 
Method of Treatment Assignment 
Before the start of the study, a randomization list will be prepared by the Sponsor utilizing a 
computer-generated software. 
7.5 
Treatments Administered 
The study products contain lidocaine hydrochloride, but additional topical or local anesthesia or 
ice pack may be used at the discretion of the Investigator to enhance the experience of the 
subjects. Any additional topical or local anesthesia used will be recorded in the CRFs. 
The injection tools (needles or cannulas) will be determined at the discretion of the Investigator. 
However, for each subject, the Investigator must use the same type of injection tool to perform 
injection for both sides of the face. Switching device within the subject will not be allowed in 
order to avoid any inconsistent comparison. Either needles or cannulas will be used per subject.  
The brand name, gauge and length of the cannulas and incision needles used by the 
Investigator will be recorded in the CRFs. 
The study products will be injected into the midface at the supraperiosteal to subcutaneous 
layer in the prezygomatic space lateral to the plane of the medial canthus, along the plane of the 
zygomatic arch ~1cm medial to hairline (described in Figure 1 below). 

 
 
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Figure 1. Description of injection boundary. 
The amount of each study products needed varies between subjects and within subjects 
bilaterally, given the natural asymmetry of the face. However, subjects will be treated to optimal 
correction of the midface as agreed by the Investigator and subjects. The product volume 
injected during each treatment session for each subject will be recorded in the CRFs. 
8. 
STUDY PROCEDURES 
There will be three (3) visits during the course of the study:  
1. Visit 1 – Screening/Baseline/Day 0  
2. Visit 2 – Week 4 (Day 28) 
3. Visit 3 – Week 24 (Day 168) 
Test design / flow chart 
D0 
W4 
W24 
Informed consent 
X 
 
 
Photo consent 
X 
 
 
Demographics/Med History 
X 
 
 
Concomitant Meds. 
X 
 
 
Inclusion and exclusion criteria 
X 
 
 
Randomization 
X 
 
 
Case report form (CRF) 
X 
X 
X 
Injection per on-label instruction 
X 
 
 
Touch up (if applicable) 
 
X 
 
Ultrasound 
X* 
X 
X 

 
 
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Standardized photography (2D and 3D) 
X 
X 
X 
Self-assessment questionnaire 
 
X 
X 
AE Reporting 
X 
X 
X 
*Ultrasound at D0 will be performed before injection and immediately post-injection for each product.  
 
8.1 
Visits and Examinations 
8.1.1. Screening/Baseline/Day 0 Visit (Visit 1) 
1. Subjects will report to the testing clinical at D0 for baseline screening. 
2. Prior to beginning of any study related activities, subjects will be informed about the 
purpose and nature of the study, the expected post-treatment events, and the potential 
risks involved with the treatments. 
3. Subjects will be given an informed consent form, HIPAA form, photography release form, 
and Code of Conduct form to read. 
4. Once subjects have completed reading, they will be interviewed to ensure their 
understanding of the aforementioned forms and be given the opportunity to ask any 
study related questions. 
5. Subjects who agree to sign the aforementioned forms will be asked to complete a 
demographic information, medical history form, and concomitant medication form. 
Subjects declining to sign any of the forms will be dismissed from the study. 
6. Subjects will be screened and qualified on the basis of the subject inclusion and 
exclusion criteria. Subjects failing to meet criteria will be dismissed from the study. 
7. Subjects will have the below assessments by Investigator or a trained Clinic staff: 
a. Clinical 2D photography by VISIA at neutral expression (3/4 left, front, 3/4 
right), at closed-mouth smile (3/4 left, front, 3/4 right), and at open-mouth 
maximum smiling (3/4 left, front 3/4 right) 
b. Clinical 3D photography by Vectra at neutral expression of full face 
c. Ultrasound on each cheek at neutral expression and at maximum smiling (left 
and right). Note: ultrasound assessment will be performed at the same area 
of the injection. 
8. Clinic staff or Investigator will assign the appropriate test treatment to each side of the 
face based on the predetermined computer-generated randomization. 
9. Investigator will instruct the subjects on each treatment administration procedure and 
perform the treatments. 
10. Investigator or Clinic staff will record the details of the administration, amount of each 
treatment used for each cheek and any subsequent adverse events (AEs) in the CRF. 
11. Immediately post-injection, subjects will have the below assessment by Investigator: 
a. Ultrasound on each cheek at neutral expression and at maximum smiling (left 
and right). Note: ultrasound assessment will be performed at the same area 
of the injection. 
12. Subjects will be instructed on any standard care post-treatment and when to contact the 
Investigator in case of emerging AEs.  
13. Subjects will be scheduled for a follow-up visit at Week 4 or Day 28 (±3 days) and 
dismissed from the Clinic.  
Note:  Subject screening /baseline/Day 0 must be on the same day. 

 
 
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Note: Whenever possible, the same investigator/staff that perform the baseline 
assessments and treatments should perform these assessments for each individual subject 
for the entire duration of the study. In the event of a change in the assigned investigator/staff 
for a given subject, the reason for change must be documented. 
 
8.1.2. Visit 2 (Week 4 or Day 28 ±3 days) 
1. Clinic staff or Investigator will record any AEs that are observed or reported. 
2. Subjects will have the below assessments: 
a. Clinical 2D photography by VISIA at neutral expression (3/4 left, front, 3/4 right), 
at closed-mouth smile (3/4 left, front, 3/4 right), and at open-mouth maximum 
smiling (3/4 left, front 3/4 right) 
b. Clinical 3D photography by Vectra at neutral expression of full face 
c. Ultrasound on each cheek at neutral expression and at maximum smiling (left 
and right). Note: ultrasound assessment will be performed at the same area from 
Visit 1. 
d. Self-assessment questionnaire 
3. Investigator will assess and offer the subjects an optional touch-up on the cheeks to 
reach the optimal aesthetic result.  
4. If touch-up is needed, the same study treatment and type of injection tool used for each 
side of the face for the baseline treatment need to be used for this step. Investigator or 
Clinic staff will record the amount of the treatment used for the assigned cheek in the 
CRFs. 
a. Touch-up treatment was not to be performed if the subjects have a disease or 
condition described in the exclusion criteria, or an ongoing treatment-related AE 
that in the opinion of the Investigator would be worsened by a touch-up 
treatment. 
5. Once completed, subjects will be scheduled for a follow-up visit at Week 24 or Day 168 
(±3 days) and be dismissed from the Clinic. 
8.1.3. Visit 3 (Week 24 or Day 168 ±3 days) 
1. Clinic staff or Investigator will record any AEs that are observed or reported. 
2. Subjects will have the below assessments: 
a. Clinical 2D photography by VISIA at neutral expression (3/4 left, front, 3/4 right), 
at closed-mouth smile (3/4 left, front, 3/4 right), and at open-mouth maximum 
smiling (3/4 left, front 3/4 right) 
b. Clinical 3D photography by Vectra at neutral expression of full face 
c. Ultrasound on each cheek at neutral expression and at maximum smiling (left 
and right). Note: ultrasound assessment will be performed at the same area from 
Visit 1. 
d. Self-assessment questionnaire 
3. Once completed, subjects will be dismissed from the Clinic. 
8.2 
Discontinued Subjects 
Any subject is free to discontinue his/her participation in this study at any time and for whatever 
reason, specified or unspecified, and without prejudice.   

 
 
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An investigator may decide to discontinue a subject from the study for safety reasons or when it 
is in the best interest of the subject. Galderma Laboratories, L.P. may also decide to 
prematurely terminate or suspend the study or the participation of a subject in the study. All data 
gathered on the subject prior to termination should be made available to Galderma 
Laboratories, L.P. 
Criteria for the discontinuation of a subject during the study will include the following:  
• 
Adverse Event 
• 
Lack of Efficacy 
• 
Pregnancy 
• 
Subject Request 
• 
Protocol Violation 
• 
Lost to Follow-up 
• 
Any unmanageable factor, in the Investigator’s opinion, that may significantly interfere 
with the protocol or interpretation of results.  
9. 
STUDY ASSESSMENTS 
All images taken from the study will be saved and shared to the Sponsor via a data-protected 
platform. 
9.1 
Clinical Photography (VISIA) 
Digital images of the subject’s face will be taken at baseline (pre-injection), week 4 (pre-touch 
up), and week 24. 
Clinic staff needs to ensure subjects to have a clean face with no makeup and to remove any 
jewelry from the area to be photographed. Subjects will be provided with a headband to keep 
hair away from the face. Subjects will be instructed to adopt neutral expression (3/4 left, front, 
3/4 right), closed-mouth smile (3/4 left, front, 3/4 right), and open-mouth maximum smiling 
expression (3/4 left, front, 3/4 right) for each photograph.  
A total of 9 full-face digital images will be taken of each subject’s face using the VISIA CR 
photo-station (Canfield Imaging Systems, Fairfield, New Jersey) with a Canon digital SLR 
camera (manufacture name, location) under the standard lighting condition. 
9.2 
Clinical Photography (Vectra 3D) 
Three (3) dimensional images of the subject’s face will be taken at baseline (pre-injection), week 
4 (pre-touch up), and week 24. 
Clinic staff needs to ensure subjects to have a clean face with no makeup and to remove any 
jewelry from the area to be photographed. Subjects will be provided with a headband to keep 
hair away from the face. Subjects will be instructed to adopt neutral, nonsmiling expression with 
their eyes gently closed, and in a relaxed positioned for each scan. 
Photography will be performed using the Vectra H2 Imaging system (Canfield Scientific, Inc., 
Canfield, NJ). The Vectra H2 utilizes raised flash to provide raked lighting to better capture and 
view skin topography and contours. Its software allows 3D viewing of the images and 
quantitative assessment of 3D parameters of the face. 
Change in volume on each cheek will be analyzed by the Vectra H2 software (left and right 
cheek separately).  

 
 
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The 3D images will be uploaded to a secure database that can be accessed by the Sponsor 
remotely.  
9.3 
Ultrasound 
Ultrasound measurements will be performed at baseline (pre-injection and immediately post-
injection), week 4 (pre-touch up), and week 24. A single ultrasound measurement will be taken 
on each subject’s left and right cheek, at neutral expression and at maximum smiling. The 
placement of the ultrasound probe needs to be at the same location of the product injection and 
for both visits to ensure consistent assessment. 
Ultrasound measurements will be performed using an 18 MHz GE Venue Fit or 42 MHz Vevo® 
MD ultrasonic transducer interfaced to a system. The probe will have a standard setting of gain, 
depth, and velocity scale to assess placement/depth of filler, size of filler aggregates, and 
vascularity around aggregates. 
9.4 
Self-Assessment Questionnaire 
Subjects will complete self-assessment questionnaire at week 4 (day 28) and week 24 (day 
168). See Appendix I: Self-assessment questionnaire.  
10. 
STATISTICAL ANALYSIS 
Data of completing subjects will be included for all statistical analyses. Descriptive statistical 
summary will be performed including N, mean, median, standard deviations, minimum, and 
maximum of values at all applicable time points and for both treatments. 
For each study treatment, mean of the change from baseline will be estimated at applicable 
post-baseline time point. The null hypothesis, that the mean change from baseline is zero, will 
be tested using methods described in the Statistical Analysis Plan table. 
The following will be calculated and reported for each evaluation parameter at applicable post-
baseline time point: 
Percent mean change from baseline = 
(visit mean score – baseline mean score)
baseline mean score
 x 100 
Percent of subjects improved/worsened = 
(number of subjects improved/worsened from baseline
total number of subjects
 x 100 
Comparison between the study treatments will be made in terms of changes from baseline. The 
null hypothesis, that the mean change from baseline is equal between the 2 study treatments at 
post-baseline time point, will be tested using methods described in the Statistical Analysis Plan 
table. 
Statistical Analysis Plan 
Evaluation 
Change from Baseline 
Comparisons between 
study treatments 
Notes/Interpretation 
Ultrasound 
measurement 
o Aggregate size 
Paired t-test; If normality 
fails, a Wilcoxon signed-
rank test will be used. 
Wilcoxon rank-sum test or 
sample t-test 
N/A 

 
 
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Volume change by 
3D imaging analysis 
Paired t-test; If normality 
fails, a Wilcoxon signed-
rank test will be used. 
Wilcoxon rank-sum test or 
sample t-test 
A higher value reflects 
an improvement in skin 
volume. 
 
Questionnaires will be tabulated, and the percentage of all response options will be reported for 
each question. 
11. 
ADVERSE EVENTS 
Throughout the course of the study, all adverse events will be monitored and reported on an 
adverse event CRF/eCRF without omitting any requested and known information. When AEs 
occur, the main concern is the safety of the study subjects. At time of the informed consent 
signature, each subject must be given the name and phone number of investigational site 
personnel for reporting AEs and medical emergencies. 
At each visit, after the subject has had the opportunity to spontaneously mention any problems, 
the investigator should inquire about AEs by asking the standard questions: 
• 
“Have you had any health problems since your last study visit?” 
• 
“Have there been any changes in the medicines you take since your last study visit?” 
AEs should be reported for any clinically relevant change, as determined by the Investigator, in 
concomitant medication(s) that is the result of an untoward (unfavorable and unintended) 
change from baseline in a subject's medical health following exposure to the study treatment. 
Changes from baseline in any protocol-specific parameter evaluated during the study are to be 
reviewed by the Investigator. In addition, the subject’s responses to any questionnaire utilized 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change from baseline in a protocol-specific parameter or question response that is 
clinically relevant, in the opinion of the investigator, is to be reported as an AE. These clinically 
relevant changes will be reported regardless of causality. 
11.1 
Definitions 
11.1.1. Adverse Events (AE) 
An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in 
the clinical study, and which does not necessarily require a causal relationship with the 
investigational product and/or a clinical trial procedure.  
An AE can be any unfavourable and unintended sign (including an abnormal laboratory value), 
symptom, or disease temporally associated with the use of the investigational product, whether 
or not related to this product. 
When an AE has a likely or very likely causal relationship with the investigational product and/or 
a clinical trial procedure, it is named undesirable effect or related AE (see Section 3).  
11.1.2. Local tolerability signs and symptoms (only applicable for cosmetic safety studies) 
In cosmetic studies, local skin tolerability includes some expected functional and/or physical 
signs on the application area, observed by the Investigator or reported by the subjects (see 
Appendix). Those signs are collected in the final report based on scales or a diary. If the 
severity of a local skin tolerability sign or symptom, is such that the product application is 

 
 
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permanently discontinued and/or a corrective concomitant treatment (except moisturizer or 
emollient) is prescribed, it is recorded as an undesirable effect (related AE). 
11.1.3. Serious Adverse Events (SAE) and serious undesirable effect/related SAE 
A Serious Adverse Event (SAE) is any adverse event which results in death, is life-threatening, 
requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent 
or significant disability/incapacity, or is a congenital anomaly/birth defect.  
Notes: 
The term “immediate vital risk” refers to an event in which the subject was at risk of death at the 
time of the event; it does not refer to an event that hypothetically might have caused death if it 
was more severe. 
Inpatient hospitalization is considered to have occurred if the subject has had to stay for a night 
at the hospital.  Hospitalization solely for the purpose of a diagnostic test (even if related to an 
AE), elective hospitalization for an intervention that was already planned before subject enrolment 
in the clinical trial, admission to a day-care facility, social admission (e.g., if the subject has no 
place to sleep), or administrative admission (e.g., for a yearly examination) should not be 
considered as a SAE. 
A serious undesirable effect/related SAE is defined as any SAE which the Investigator classifies 
as having a reasonable possibility for a causal relationship with the investigational product 
and/or the clinical trial procedure. 
11.2 
Severity Assessment 
For all AEs occurring during the clinical trial, the Investigator is to classify and report the intensity 
of AEs using the following definitions as a guideline: 
- 
Mild: awareness of signs and symptoms, but easily tolerated 
- 
Moderate: discomfort, enough to cause interference with usual activity 
- 
Severe: incapacitating, with inability to work or perform usual activity. 
11.3 
Causality Assessment 
The Investigator is to assess the causal relationship (causality) between an adverse event and 
the investigational product and/or the clinical trial procedure according to the following definitions 
(Decision of 25 November 2013 on Guideline on Annex I to Regulation (EC) No 1223/2009 
(2013/674/EU) - Causality assessment of undesirable effect caused by cosmetic products): 
• 
Very likely 
• 
Likely 
• 
Not clearly attributable 
• 
Unlikely 
• 
Excluded 
Medical judgment should be used to determine the relationship, considering all relevant factors 
including the pattern of reaction, temporal relationships, positive de-challenge or re-challenge, 
relevant medical history, and confounding factors such as co-medication or concurrent diseases. 

 
 
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11.4 
Collection, Management and Reporting Procedures 
The period of collection of adverse events starts from the time of signature of the Informed 
Consent Form (ICF) by the subject (and/or, for subjects who are minor, by the parents/legal 
representatives) until the end of the subject’s participation in the clinical study.  
If a Serious Adverse Event (SAE) is on-going at the final clinical trial visit, it should be followed by 
the Investigator until it has resolved or has reached a stable condition.  
After the subject completes the clinical study, the Investigator should also inform the Sponsor 
(see Sponsor’s contact details below) if he/she becomes aware of an SAE involving a subject 
who has participated in the clinical study.  
At each post-enrollment visit, the Investigator will question the subject about AEs using an open 
non-persuasive question to elicit reporting of AEs, for example “Have you noticed any change in 
your health since the last visit?” Direct questioning and examination will be performed when 
appropriate.  
The Investigator will obtain and maintain in the subject’s files all pertinent medical records, and (if 
applicable) information and medical judgment from colleagues who assisted in the treatment and 
follow-up of the subject.  If necessary, the Investigator will contact the subject’s personal physician 
or hospital staff to obtain further details.  
As a minimum, Investigators are requested to report in the Case Report Form (CRF) and 
in the report all related adverse events (i.e. undesirable effects) and all Serious Adverse 
Events, whether related or not. 
11.4.1. Management and reporting procedures for undesirable effects (i.e. related adverse 
events 
Undesirable effects should be recorded in the CRF and summarized in the report in a summary 
table with at minimum the subject number, AE number, AE diagnosis or signs and symptoms, 
location, date of onset, seriousness, severity, action taken, relationship, date of resolution and 
concomitant treatment associated as well as a detailed narrative of the event. 
In addition, based on his/her medical judgment, the Investigator will assess whether an 
undesirable effect requires immediate (i.e. within 24 hours) reporting to the Sponsor. In such 
cases, the summary table will be sent to the Sponsor, along with the AE narrative and any other 
relevant information (concomitant treatments, product weighing, …).  
All undesirable effects should be appropriately documented, i.e. any relevant information such as 
demographics, medical history and concomitant therapies should be recorded in the CRF. 
The Investigator is to monitor and record the progress of the adverse effect until the last subject’s 
study visit. 
The Investigator is to update the AE narrative as appropriate, each time follow-up information is 
collected and when the final outcome of the adverse effect is known. 
11.4.2. Management and reporting procedures for Serious Adverse Events  
The Investigator is to take the following steps: 

 
 
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1. Take prompt and appropriate medical action, if necessary. The safety of clinical trial 
subjects is the first priority 
2. Ensure the AE is classified as an SAE. Immediately inform the Sponsor’s representative 
of the event by email or fax (see contact details below) and discuss further actions to be 
taken: 
e-mail: pharmacovigilance@galderma.com 
3. Complete the Serious Adverse Event (SAE) form provided by the Sponsor’s 
representative Within 24 hours, fax or send by e-mail to the Sponsor’s representative 
the completed SAE form, accompanied any other relevant information (e.g. test results or 
medical records).  
4. Monitor, record and send to Sponsor’s representative the progress of the event until it 
resolves or reaches a stable outcome, with or without sequelae (send the updated SAE 
form with follow-up information and any other relevant information to Sponsor’s 
representative). 
5. Obtain and maintain in the subject’s file all pertinent medical records, information, and 
medical judgments from colleagues who assisted in the treatment and follow-up of the 
subject. If necessary, contact the subject’s personal physician or hospital staff to obtain 
further details. 
6. If applicable, comply with the regulatory requirement(s) related to the reporting of SAEs 
to the Institutional Review Board (IRB) / Independent Ethics Committee (IEC). 
11.5 
Pregnancy 
Pregnancy itself is not to be considered as an adverse event. If a pregnancy occurs during the 
clinical trial, the product application should be stopped immediately, the subject should be 
withdrawn from the clinical study and Sponsor’s representative (see Sponsor’s contact details 
above) should be informed within 24 hours.  
Pregnancy must be recorded as a reason for discontinuation in the exit form of the CRF.  
No specific follow-up of pregnancy is required, except if it is a regulatory requirement in the 
country(ies) where the clinical trial is conducted. 
12. 
ETHICAL AND REGULATORY PROCEDURES 
12.1 
Research Standards/Good Clinical Practice 
This study will be conducted in accordance with all applicable guidelines for the protection of 
human subjects for research as outlined in 21 CFR 50 the accepted standards for Good Clinical 
Practice (GCP), and the standard practices of SGS Stephens in accordance with the protocol 
and amendment(s) as applicable. 
12.2 
Quality Assurance/Audit/Inspection 
To ensure compliance with GCP and all applicable regulatory requirements, Galderma 
Laboratories, L.P. may conduct a quality assurance audit of the site records, and the regulatory 
agencies may conduct a regulatory inspection at any time during or after completion of the 
study. The investigator must agree to grant the auditor(s) and inspector(s) direct access to all 

 
 
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relevant documents and to allocate their time and the time of their staff to discuss any 
findings/relevant issues. 
12.3 
Institutional Review Board 
This study (protocol, ICF and all addenda) will be reviewed and approved by Sterling IRB. The 
study will not be activated and subjects will not be consented, receive any study products, or 
participate in any study procedures until the IRB has approved the protocol and the ICF. In 
addition, the IRB will review the study before any significant change in the protocol is initiated. 
After each review, the IRB's approval will be documented in a letter to the Investigator and a 
copy of the IRB approval letter will be forwarded to the Sponsor. 
13. 
STUDY CONDUCT CONDISERATIONS 
13.1 
Clinical Monitoring 
The conduct of the study will be closely monitored by representatives of Galderma Laboratories, 
L.P. following GCP, ICH guidelines, applicable SOPs, guidelines, and all local regulations. The 
clinical investigation will be monitored to ensure that:  the rights and well-being of the subjects 
are protected; the reported data are accurate, complete and verifiable from applicable source 
documents; and the study is conducted in accordance with the currently approved protocol and 
any other study agreements, GCP, and all applicable regulatory requirements. The investigator 
will allow the Galderma Laboratories, L.P. representatives to have access to all study records, 
CRF/eCRFs, corresponding subject medical records, and any other documents considered 
source documentation. The investigator also agrees to assist the representatives, if required, 
which can include AE reporting. All study monitoring details will be detailed in the Clinical 
Monitoring Plan. 
13.2 
Data Collection 
Investigators must keep accurate records of all subjects' visits and all procedures done, being 
sure to include all pertinent study related information from which CRF/eCRF data will be 
recorded. Data for this study may be recorded in the subject's chart (e.g. source documents / 
electronic records) or if approved by the Galderma Laboratories, L.P. directly into CRF/eCRFs. 
If electronic records are maintained, the method of verification must be determined in advance 
of starting the study. The process of administering the informed consent must also be 
documented. Any and all side effects and AEs with the concomitant therapies associated must 
be thoroughly documented. Results of any diagnostic tests conducted during the study should 
be included in the source documentation. Pertinent telephone conversations with the subjects 
and/or Galderma Laboratories, L.P. concerning the study will be documented and kept on file. 
It is required that the author of an entry in the source documents be identifiable. Direct access to 
all source documentation (medical records) must be allowed for the purpose of verifying that the 
data recorded in the CRF/eCRF are consistent with the original source.  
Only designated individuals may complete the CRF/eCRFs. The principal investigator will 
review the reported data and certify that the CRF/eCRFs are accurate and complete.  
After monitoring has occurred at the clinical site(s) and the CRF/eCRFs have been reviewed, 
additional data clarifications and/or additions may be needed including AE reporting. Data 
clarifications and/or additions are documented and are part of each subject’s CRF/eCRFs. 

 
 
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13.3 
Record Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by Galderma Laboratories, L.P. and the investigator’s files will be reviewed as part of 
the ongoing study monitoring. The records must be easily accessible when needed (e.g., for a 
Galderma Laboratories L.P.’s audit or regulatory inspection) and must be available for review in 
conjunction with assessment of the facility, supporting systems, and relevant site personnel. 
Financial information is not subject to regulatory inspection and should be kept separately.  
Galderma Laboratories, L.P. will inform the investigator of the time period for retaining the site 
records in order to comply with all applicable regulatory requirements. The minimum retention 
time will meet the strictest standard applicable to a particular site, as dictated by local 
laws/regulations, Galderma Laboratories, L.P. SOPs, and/or institutional requirements. 
The investigator should take measures to prevent accidental or premature destruction of these 
documents. If the investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. Galderma Laboratories, L.P. must be notified in writing of the name 
and address of the new custodian. 
13.4 
Changes in Study Conduct/Amendments 
No amendment will be done for modification(s) due to change in logistical or administrative 
aspect of the study (e.g., change in monitors, change of telephone numbers). In such a case, 
the appropriate institution(s) and/or person(s) will be notified of the changes. 
Modification of the protocol is prohibited without prior written agreement in the form of a protocol 
amendment. All amendments will be created by Galderma Laboratories, L.P. and must be 
approved by the IRB prior to implementation except when required to mitigate immediate safety 
risks or when the changes involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all Subjects/subjects currently enrolled in the study may 
be required by the IRB to sign the approved, revised informed consent form. 
13.5 
Confidentiality 
All the data provided to the investigator and his/her staff and all data obtained through this 
Galderma Laboratories, L.P. protocol will be regarded as confidential and proprietary in nature 
and should not be disclosed to any third party without Galderma Laboratories, L.P.’s written 
consent” 
 
14. 
REFERENCES 
1. Callan P, Goodman GJ, Carlisle I, et al. Efficacy and safety of a hyaluronic acid filler in 
subjects treated for correction of midface volume deficiency: a 24 month study. Clin 
Cosmet Investig Dermatol. 2013;6:81–89. 
2. Cohen JL, Dayan SH, Brandt FS, et al. Systematic review of clinical trials of small- and 
large-gel-particle hyaluronic acid injectable fillers for aesthetic soft tissue 
augmentation. Dermatol Surg. 2013;39:205–231. 

 
 
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3. Weiss RA, Moradi A, Bank D, et al. Effectiveness and safety of large gel particle 
hyaluronic acid with lidocaine for correction of midface volume deficit or contour 
deficiency. Dermatol Surg. 2016;42(6):699-709. 
 
 

 
 
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APPENDIX I: SELF-ASSESSMENT QUESTIONNAIRE 
VISIT 2 (DAY 28 OR WEEK 4) 
Preference questions 
Left 
Right 
No Difference 
a) Which cheek do you prefer? 
 
 
 
b) Which cheek has the best contour? 
 
 
 
c) Which cheek looks more natural? 
 
 
 
 
Thinking about the left 
side of your face… 
Strongly 
Agree 
Agree 
Neutral 
(neither 
agree nor 
disagree) 
Disagree 
Strongly 
Disagree 
a) I love how my cheek 
looks in selfies/photos 
 
 
 
 
 
b) I am camera-ready 
with my natural contour 
 
 
 
 
 
c) My cheek feels natural 
 
 
 
 
 
d) My cheek makes me 
feel good about myself 
 
 
 
 
 
e) I am happy with my 
contoured cheek 
 
 
 
 
 
f) My cheek looks natural 
when smiling 
 
 
 
 
 
 
Thinking about the right 
side of your face… 
Strongly 
Agree 
Agree 
Neutral 
(neither 
agree nor 
disagree) 
Disagree 
Strongly 
Disagree 
a) I love how my cheek 
looks in selfies/photos 
 
 
 
 
 
b) I am camera-ready 
with my natural contour 
 
 
 
 
 
c) My cheek feels natural 
 
 
 
 
 
d) My cheek makes me 
feel good about myself 
 
 
 
 
 
e) I am happy with my 
contoured cheek 
 
 
 
 
 

 
 
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f) My cheek looks natural 
when smiling 
 
 
 
 
 
 
Testimonials (please provide any comments on your experience, treatments, 
satisfaction/dissatisfaction, or anything related to this study) 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
 
VISIT 3 (WEEK 24 OR DAY 168) 
 
Preference questions 
Left 
Right 
No Difference 
a) Which cheek do you prefer? 
 
 
 
b) Which cheek has the best contour? 
 
 
 
c) Which cheek looks more natural? 
 
 
 
 
Forced Preference questions 
Left 
Right 
a) If you have to choose, which cheek 
do you prefer? 
 
 
b) If you have to choose, which cheek 
has the best contour? 
 
 
c) If you have to choose, which cheek 
looks more natural? 
 
 
 
Thinking about the left 
side of your face… 
Strongly 
Agree 
Agree 
Neutral 
(neither 
agree nor 
disagree) 
Disagree 
Strongly 
Disagree 
a) I love how my cheek 
looks in selfies/photos 
 
 
 
 
 
b) I am camera-ready 
with my natural contour 
 
 
 
 
 

 
 
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c) My cheek feels natural 
 
 
 
 
 
d) My cheek makes me 
feel good about myself 
 
 
 
 
 
e) I am happy with my 
contoured cheek 
 
 
 
 
 
f) My cheek looks natural 
when smiling 
 
 
 
 
 
 
Thinking about the right 
side of your face… 
Strongly 
Agree 
Agree 
Neutral 
(neither 
agree nor 
disagree) 
Disagree 
Strongly 
Disagree 
a) I love how my cheek 
looks in selfies/photos 
 
 
 
 
 
b) I am camera-ready 
with my natural contour 
 
 
 
 
 
c) My cheek feels natural 
 
 
 
 
 
d) My cheek makes me 
feel good about myself 
 
 
 
 
 
e) I am happy with my 
contoured cheek 
 
 
 
 
 
f) My cheek looks natural 
when smiling 
 
 
 
 
 
 
Testimonials (please provide any comments on your experience, treatments, 
satisfaction/dissatisfaction, or anything related to this study) 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________