Clinical trial NCT04755595
Conditions: Dermatological Non-Disease
Sponsor: State University of New York - Downstate Medical Center
Start date: 2021-03-09; Completion date: 2021-05-19
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers worldwide expecting to invest in aesthetic treatments in the upcoming year, it is imperative to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a millennial cohort. The investigators hypothesize that a combination approach to facial aesthetic treatment in a millennial cohort will result in increased patient-reported satisfaction in multiple areas, including perception of aging concerns and quality of life.

Detailed description:
This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to the millennial generation (i.e., born between January 1, 1981 and December 31, 1996)1 and meet eligibility criteria will be enrolled. Study participants will receive all three injectables during a single procedure, with an optional touch-up treatment at 2 weeks. The primary endpoint is the change in satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall Scale. Other outcome measures include various FACE-Q Aesthetic scales, digital skin imaging analysis, photographs, and rater-blinded clinical assessment using the Global Aesthetic Improvement Scale (GAIS).

Arms: arm 1: Study participants will receive all three injectables: Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler) during a single procedure, with an optional touch-up treatment at 2 weeks.
Interventions: intervention 1: Botox Cosmetic Injectable Product intervention 2: Juvéderm Voluma XC intervention 3: Juvéderm Volbella XC
Intervention descriptions: intervention 1: Acetylcholine release inhibitor and a neuromuscular blocking agent intervention 2: Gel implants consisting of cross-linked hyaluronic acid intervention 3: Gel implants consisting of cross-linked hyaluronic acid

Protocol documents:
Prot_SAP_000.pdf: 
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Combination Facial Aesthetic Treatment in Millennials 
NCT04755595 
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Ja 
SUNY DOWNSTATE MEDICAL CENTER 
RESEARCH PROTOCOL 
 
PROTOCOL TITLE 
Combination Facial Aesthetic Treatment in Millennials 
VERSION 
1.0 (25 February 2020) 
PRINCIPAL INVESTIGATOR 
Jared Jagdeo, MD, MS 
IRB# 1547415 
INTRODUCTION/BACKGROUND INFORMATION 
With the destigmatization of cosmetic procedures, minimally invasive procedures have become an 
additional cosmetic tool in the aesthetic tool-box of the modern-day millennial, defined by the Pew 
Research Center as individuals born between 1981 and 1996.1 Per Allergan’s 360° Aesthetics 
Report, “82% of millennial consumers believe injectable treatments to be socially acceptable,” with 
a reported 52% having considered dermal fillers and 60% having considered neuromodulating 
agents.2 Worldwide, millennials are also more likely to consider preventative treatments compared 
to any other age-group.2  The American Academy of Plastic and Reconstructive Surgery’s 2018 
annual survey further demonstrates the growing demand of cosmetic procedures in this particular 
consumer group, citing a 24% increase in cosmetic procedures (surgery and/or injectables) in 
patients under 30 since 2013 (58% to 72%).3 In particular, botulinum toxin, laser hair removal, and 
soft tissue fillers were reported to be the most popular minimally invasive cosmetic procedures.4 
These reported findings reveal a notable trend in young adults seeking to enhance their physical 
appearance via cosmetic procedures as adjunct tools to accompany non-invasive cosmetic 
products.2-4 The rise of minimally invasive procedures, particularly injectables, such as fillers and 


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neuromodulators, is likely multifactorial in nature. Owing to the affordability of cosmetic procedures 
relative to more invasive plastic surgery, the subtle, yet appreciable results, as well as reasonable 
recovery times, patients are seeking convenient procedures to achieve their intended aesthetic 
goals.   
Injectables such as fillers and neuromodulating agents have been widely used to achieve a 
youthful aesthetic. While each patient has their own desired aesthetic goals, the current socially-
desirable beauty trend emphasizes the accentuation of one’s physical features while maintaining 
a natural aesthetic.3 Allergan’s 360° Aesthetics Report cites the most commonly used terms to 
describe beauty in millennials include: soft, smooth, and natural, among others.2  
Among the latest cosmetic trends in the millennial consumer group is prejuvenation, a portmanteau 
combining the words prevention and rejuvenation.5 Prejuvenation utilizes minimally-invasive 
procedures with the intention of maintaining a youthful appearance and ideally delaying visible 
signs of aging.5-6 This trend highlights the focus of millennials on early maintenance treatments to 
produce natural-appearing results in order to avoid or delay more invasive procedures down the 
line. Cosmetic injectables such as neuromodulators and dermal fillers have become the leading 
products utilized to achieve these results.4 Neuromodulating agents have been used cosmetically 
to reduce the appearance of dynamic rhytids and fine lines while dermal fillers have been utilized 
to improve volume distribution and ultimately achieve balanced facial contouring.7-8,11 By inhibiting 
muscles from contracting, neuromodulating agents decrease facial movement and in theory may 
be used preventatively to suspend the development of wrinkles.7-8 A long-term twin study seeking 
to evaluate the prevention of wrinkles with neuromodulating agents concluded that long-term 
onabotulinumtoxinA treatment can effectively prevent facial lines present at rest.9 This study, 
although limited by design, suggests that long-term treatment with neuromodulating agents can 
lead to the prevention of future wrinkles, providing supporting evidence for prejuventation. An 
additional study demonstrated similar results with long-term treatment of glabellar rhytids with 
onabotulinumtoxinA, further supporting the use of neuromodulators for prejuventation.10  
Given the subjectivity of beauty standards and desired outcomes, patient satisfaction remains 
paramount in evaluating the success of aesthetic treatments. The HARMONY study utilized 
patient-reported outcomes as a primary measure for a multimodal facial aesthetic treatment in a 
cohort of patients aged 37-65.12 While the HARMONY study’s primary outcome measure focused 
on patient satisfaction of post-procedural facial appearance, several of their secondary outcome 
measures were reflective of their cohort being comprised of an older-age group: patient’s perceived 


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age and reduction in facial rhytids, lines, and folds.12 Because our study seeks to focus on the 
millennial population, most of whom will show little to no signs of aging, our primary outcome 
measure will relate to patient satisfaction with their overall facial appearance, without focusing on 
the reduction in visible signs of aging. A survey evaluating motivation for cosmetic surgery details 
low self-esteem and low self-rated attractiveness as critical contributory factors.13 Given that it is 
pertinent to evaluate for psychosocial factors in cosmetic procedures, our secondary measures will 
focus on patient’s self-perception, self-esteem, and decision satisfaction to explore the 
psychosocial impact of minimally invasive cosmetic procedures in millennials.  
With 63% of consumers willing to consider investing in facial aesthetics and 73% of consumers 
worldwide expecting to invest in aesthetic treatments in the upcoming year,2 it is imperative to 
explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a 
millennial cohort. 
 
AIMS & OBJECTIVES 
Primary objective:  
• 
To evaluate changes in patient’s satisfaction with their appearance following a combination 
facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance Overall 
Scale, at 2 months after the procedure compared to baseline 
Secondary objectives: 
• 
To assess the motivating factors, concerns, and treatment preferences of millennials who 
seek facial aesthetic treatment 
• 
To assess patient expectations regarding the impact of facial aesthetic treatment on their 
lives, using the FACE-Q Expectations Scale 
• 
To assess changes in psychosocial factors after facial aesthetic treatment, using FACE-Q 
Social Function Scale and FACE-Q Psychological Function Scale 
• 
To assess changes in self-perceived age after facial aesthetic treatment, using the FACE-
Q Patient-Perceived Age Visual Analogue Scale and FACE-Q Aging Appraisal Scale 
• 
To assess changes in patient satisfaction with their appearance after facial aesthetic 
treatment, using the FACE-Q Aesthetic Scales 


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• 
To assess patient satisfaction with facial aesthetic treatment, using the FACE-Q 
Satisfaction with Outcome Scale 
• 
To evaluate clinician assessment of patient’s aesthetic appearance using the Global 
Aesthetic Improvement Scale (GAIS), as completed by a blinded evaluator at 2 months 
after facial aesthetic treatment 
HYPOTHESES 
We hypothesize that a combination approach to facial aesthetic treatment in a millennial cohort will 
result in increased patient-reported satisfaction in multiple areas, including perception of aging 
concerns and quality of life. 
 
METHODS 
OVERVIEW OF THE STUDY DESIGN 
This is a single-center, prospective, rater-blinded, pilot study to evaluate patient satisfaction with 
facial aesthetic treatment using a combination of botulinum toxin and dermal fillers. The three types 
of injectables are Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC (hyaluronic acid 
gel filler), and Juvéderm Volbella XC (hyaluronic acid gel filler). Twenty individuals who belong to 
the millennial generation (i.e., born between January 1, 1981 and December 31, 1996)1 and meet 
eligibility criteria will be enrolled. Study participants will receive all three injectables during a single 
procedure, with an optional touch-up treatment at 2 weeks. The primary endpoint is the change in 
satisfaction after facial aesthetic treatment, using the FACE-Q Satisfaction with Facial Appearance 
Overall Scale. Other outcome measures include various FACE-Q Aesthetic scales, digital skin 
imaging analysis, photographs, and rater-blinded clinical assessment using the Global Aesthetic 
Improvement Scale (GAIS). 
 
 
 
 


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STUDY POPULATION 
INCLUSION AND EXCLUSION CRITERIA  
Inclusion Criteria 
• 
Date of birth between January 1, 1981 and December 31, 1996 
• 
Naiveté to facial injections of botulinum toxin and dermal filler 
• 
Desire to receive all three facial cosmetic injectables in the study 
• 
Suitable candidate to receive facial injectables, as determined by clinician judgment 
• 
Provision of written informed consent for all study procedures 
• 
Stated willingness to comply with all study procedures and availability for the duration of 
the study 
Exclusion Criteria 
• 
Desire to receive only one or two of the facial injectables 
• 
Dermatologic or medical conditions at the injection sites that may be exacerbated by the 
study procedures (e.g., severe acne, active infection, open sores or lesions, history of cold 
sores) 
• 
Pre-existing cardiovascular disease (e.g., heart failure, coronary artery disease) 
• 
Pre-existing swallowing or respiratory disorders (e.g., dysphagia, asthma, COPD) 
• 
Peripheral motor neuropathy disease, amyotrophic lateral sclerosis, or neuromuscular 
junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)  
• 
Known hypersensitivity or allergies to any of the components of the administered 
drugs/devices in the study (e.g., Gram-positive bacterial proteins, lidocaine) 
• 
History of anaphylaxis or multiple severe allergies 
• 
History of a bleeding or coagulation disorder  
• 
Pregnant or breast-feeding  
• 
Current and/or scheduled use of the following medications: immunosuppressants, 
anticoagulants (e.g., warfarin, heparin, rivaroxaban), antiplatelets (e.g., clopidogrel, 
ticagrelor, NSAIDs), antibiotics (e.g., aminoglycosides), anticholinergics, muscle relaxants 
• 
Procedures or treatments to the face in the past 14 days (e.g., chemical peel, laser surgery, 
microdermabrasion) 


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• 
Plan to undergo elective cosmetic procedure on the face (e.g., laser surgery, plastic 
surgery, physician-strength chemical peel) during the study 
• 
Any medical condition(s) that could be compromised by participating in the study 
SAMPLE SIZE 
20 
METHOD FOR SCREENING FOR ELIGIBILITY 
At the in-person screening visit, the research team will screen potential study subjects by asking 
about demographics, medical history pertinent to the eligibility criteria, and prior and concomitant 
medications. On the case report form titled “Eligibility Checklist,” all inclusion criteria boxes must 
be marked yes and all exclusion criteria boxes must be marked no for a potential study subject to 
be eligible to enroll and participate in the study. 
INCLUSION OF VULNERABLE POPULATIONS  
Vulnerable populations will not be included in this study.  
STATISTICAL CONSIDERATIONS 
ANALYSIS PLAN 
Statistical analyses will be performed using SAS version 9.4 statistical package (SAS Institute, 
Cary, NC, USA) or similar. Efficacy analyses will be conducted on the modified intent-to-treat 
population (mITT). Statistical analysis will be modeled after the HARMONY study.12 The raw scores 
of the primary outcome measure (FACE-Q Satisfaction with Facial Appearance Scale) will be 
transformed by the Rasch measurement method into a 0-to-100 point scale.14-15 Data will be 
analyzed using a paired t-test. Secondary outcome measures will also be analyzed using paired t-
tests. Categorical variables will be presented as proportions. Pearson χ2 tests will be used to 
compare categorical variables between subgroups. A p-value < 0.05 is considered to be 
statistically significant.  


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Subgroup analysis will be performed on participants that have demonstrated significant 
improvement on outcome measures, as defined by post-treatment scores falling outside the 95% 
confidence intervals for baseline scores.  
Adverse events (AE) will be categorized into general, product-related, or procedure-related AEs. 
These will be summarized by severity of reported event, timing of reported event, and percentage 
of participants with each reported event.  
SAMPLE SIZE JUSTIFICATION 
This is a pilot study that is designed to evaluate differences in satisfaction with facial appearance 
before and after the study intervention. No power analysis was performed to determine a target 
sample size. 
 
PROCEDURES AND DATA COLLECTION 
All study procedures will take place in Dr. Jared Jagdeo’s Photomedicine Research Clinic, located 
in Suite C of University Hospital of Brooklyn, or the Clinical and Translational Science Center 
(CTSC) at SUNY Downstate Medical Center. All study participants must provide written informed 
consent before any study related procedures are performed. The study will be conducted as 
outlined in the schedule of assessments (Table 1). 
SCREENING 
At the screening visit, potential study participants will be asked to provide the following information 
to be recorded in the case report forms: demographics (date of birth, sex, race, ethnicity); medical 
history pertinent to the eligibility criteria; prior and concomitant medications. The research team 
will determine whether potential study participants meet the inclusion and exclusion criteria 
specified in the “Eligibility Checklist” case report form. Subjects who meet all of the inclusion criteria 
and none of the exclusion criteria will be eligible for study entry. 
 
 
 


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FACIAL AESTHETIC TREATMENT 
Study participants will undergo an elective, minimally invasive cosmetic procedure involving the 
administration of botulinum toxin and dermal fillers. All procedures will be performed by Dr. Jared 
Jagdeo (principal investigator), a board-certified dermatologist and cosmetics expert.  
DRUG & DEVICE DESCRIPTION 
The three types of facial injectables to be used are Botox Cosmetic (onabotulinumtoxinA), 
Juvéderm Voluma XC (hyaluronic acid gel filler), and Juvéderm Volbella XC (hyaluronic acid gel 
filler). The U.S. Food and Drug Administration (FDA) classifies Juvéderm Voluma XC and 
Juvéderm Volbella XC as devices, and Botox Cosmetic as a drug. Botox Cosmetic is an 
acetylcholine release inhibitor and a neuromuscular blocking agent. Juvéderm Voluma XC and 
Juvéderm Volbella XC are gel implants consisting of cross-linked hyaluronic acid. 
The FDA has approved these treatments for the following indications: 
o Botox Cosmetic: injection into muscle to temporarily improve the appearance of 
frown lines between the eyebrows and crow’s feet lines in adults 
o Juvéderm Voluma XC: deep (subcutaneous and/or supraperiosteal) injection for 
cheek augmentation to correct age-related volume deficit in the mid-face in adults 
o Juvéderm Volbella XC: injection into the lips for lip augmentation and for correction 
of perioral lines in adults 
DOSAGE AND ADMINISTRATION 
The products will be administered by intramuscular injection according to the manufacturer’s 
prescribing information/package insert. The injection sites, treatment areas, and volumes/dosages 
of each product used will be documented in the appropriate case report form. The lot number and 
expiration date for each product will also be recorded.  
Each participant will receive all three products using standard injection technique during a single 
procedure: 
1. Botox Cosmetic (onabotulinumtoxinA): up to 50 units in the following three 
anatomic regions 


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a. Frontalis (forehead): up to 20 units  
b. Lateral canthal area (crow’s feet lines): up to 10 units on each side 
c. Glabella (between eyebrows): up to 10 units  
2. Juvéderm Voluma XC: up to 2 cc to the mid-face (cheeks) 
3. Juvéderm Volbella XC: up to 2 cc to the lips and/or perioral area, per participant 
preference and physician judgment 
 
Study participants will be given the option to receive a touch-up at approximately 2 weeks after the 
initial procedure. At the optional 2 week touch-up visit, participants may elect to receive additional 
injections of any of the products, depending on their treatment preferences and the clinician’s 
judgment. 
REVERSAL AGENTS 
Hyaluronidase will be available to dissolve fillers that have been placed incorrectly, excessively, or 
unevenly. If indicated and necessary, hyaluronidase will be injected in the affected areas according 
to the manufacturer’s package insert. 
POST-PROCEDURE INSTRUCTIONS 
Study participants will be counseled on post-procedure care and precautions according to standard 
clinical practice following facial aesthetic injectable treatment. In addition to the verbal instructions 
given after the procedure, written instructions will also be provided (Post-Procedure Instructions: 
Dermal Fillers and Botulinum Toxin Therapy). A member of the research team will contact each 
participant the day after the procedure to assess for the occurrence of any AEs or concerns. 
STORAGE AND HANDLING 
All products will be stored according to the manufacturer’s guidelines in a secure area with 
restricted access. The drug (Botox Cosmetic) will be stored in the Investigational Drug Pharmacy 
at University Hospital of Brooklyn and dispensed prior to each cosmetic procedure by the Research 
Pharmacist.  
 
Botox Cosmetic: Botox Cosmetic is a vacuum-dried powder supplied in a single-dose 50U vial. 
Unopened vials of Botox Cosmetic are stored in a refrigerator 2°C to 8°C. Reconstituted Botox 
Cosmetic will be administered within 24 hours.  
 


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Juvéderm Voluma XC: Juvéderm Voluma XC injectable gel is supplied in individual treatment 
syringes with 27G ½” or 25G 1” needles for single-patient use and ready for injection. Juvéderm 
Voluma XC is stored at room temperature (up to 25°C/77°F). 
 
Juvéderm Volbella XC: Juvéderm Volbella XC injectable gel is supplied in individual treatment 
syringes with 30G or 32G needles for single-patient use and ready for injection. Juvéderm Volbella 
XC is stored at room temperature (up to 25°C/77°F). 
CONCOMITANT TREATMENTS 
Study participants will not be allowed to undergo any elective cosmetic procedures on the face 
during the study, defined as the time period between the baseline visit and the final 2 month follow-
up visit. Elective cosmetic procedures on the face include, but are not limited to: plastic surgery 
(e.g., surgical facelift or thread lift), laser surgery, physician-strength chemical peels, 
dermabrasion, phototherapy, neuromodulators, dermal fillers. 
 
EFFICACY ASSESSMENTS 
Efficacy assessments are conducted at baseline (prior to undergoing the facial aesthetic treatment) 
and at the follow-up study visits scheduled at 2 months after the procedure. Participants will be 
asked to attend the study visits without facial make-up or to remove any facial make-up prior to the 
assessments. 
SATISFACTION QUESTIONNAIRES - BASELINE 
At the baseline visit, participants will be asked to complete several validated questionnaires to 
evaluate their current level of satisfaction with various facial areas, as well as psyschosocial 
attitudes 
and 
perceptions 
regarding 
facial 
aesthetic 
treatments. 
The 
following 
surveys/questionnaires will be administered prior to the procedure: 
• 
Millennial Facial Aesthetics Survey 
• 
FACE-Q Aging Appraisal                                     
• 
FACE-Q Patient-Perceived Age VAS                               
• 
FACE-Q Expectations 
• 
FACE-Q Satisfaction with Facial Appearance        


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• 
FACE-Q Social Function                                                   
• 
FACE-Q Psychological Function                                                                                                                  
• 
FACE-Q Appraisal of Lines: Overall                     
• 
FACE-Q Appraisal of Lines: Between Eyebrows             
• 
FACE-Q Appraisal of Lines: Forehead 
• 
FACE-Q Appraisal of Lines: Crow’s Feet             
• 
FACE-Q Satisfaction with Cheeks                                   
• 
FACE-Q Appraisal of Lines: Lips and/or FACE-Q Satisfaction of Lips (depending on the 
area treated with filler)       
SATISFACTION QUESTIONNAIRES – FOLLOW-UP                                                                   
The following surveys/questionnaires will be administered at the final study visit: 
• 
FACE-Q Aging Appraisal                                     
• 
FACE-Q Patient-Perceived Age VAS                               
• 
FACE-Q Satisfaction with Facial Appearance       
• 
FACE-Q Satisfaction with Outcome  
• 
FACE-Q Social Function                                                   
• 
FACE-Q Psychological Function                                                                                                                  
• 
FACE-Q Appraisal of Lines: Overall                     
• 
FACE-Q Appraisal of Lines: Between Eyebrows             
• 
FACE-Q Appraisal of Lines: Forehead 
• 
FACE-Q Appraisal of Lines: Crow’s Feet             
• 
FACE-Q Satisfaction with Cheeks                                   
• 
FACE-Q Appraisal of Lines: Lips and/or FACE-Q Satisfaction of Lips (depending on the 
area treated with filler)     
• 
Exit Questionnaire 
PHOTOGRAPHY                                                                                                                      
Standardized photographs of the face will be taken in 3 views – full frontal, left lateral, and right 
lateral – with a digital single-lens reflex (DSLR) camera. Additional photographs will be taken using 


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the VECTRA H2 3D camera (Canfield Scientific, Parsippany, NJ) and VISIA Complexion Analysis 
System (Canfield Scientific, Parsippany, NJ) for documentation purposes. 
 
CLINICAL EVALUATION                                                                                                          
A blinded evaluator will provide a score on the Global Aesthetic Improvement Scale (GAIS) to 
assess overall cosmetic results based on photographs obtained at the final study visit as compared 
to baseline. 
Score 
State 
3 
Exceptionally improved 
2 
Much improved 
1 
Improved 
0 
No change 
-1 
Worse 
 
SAFETY AND TOLERABILITY 
Throughout the study, participants will be monitored for the occurrence of AEs. Participants will be 
asked to document any AEs in a diary and to notify the research team of any treatment-emergent 
concerns. All AEs, serious AEs (SAEs), and unanticipated problems will be documented in the 
appropriate case report form and reported to the safety monitor and Allergan as specified in the 
section “Data and Safety Monitoring.”  
 
An AE is any untoward medical occurrence in a subject administered a study intervention and 
which does not necessarily have a causal relationship with the study intervention. At each study 
visit, the subject will be assessed for the occurrence of new and ongoing AEs. Dermal safety and 
tolerability assessments that result in the subject requiring concomitant therapy or discontinuation 
from the study will be reported as an AE. The following data will be collected on all AEs and 
recorded on the appropriate case report form: 
• 
Event description 


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• 
Date of onset 
• 
Date of resolution 
• 
Serious or non-serious 
• 
Maximum severity: mild, moderate, or severe 
• 
Relationship to the study intervention: not related, unlikely, potentially, probably, or 
definitely 
• 
Treatment, if initiated 
• 
Action taken with the study intervention: none, temporarily interrupted, or permanently 
withdrawn 
• 
Outcome: resolved without sequelae, resolved with sequelae, resolving, or ongoing 
 
FOLLOW-UP 
Follow-up study visits occur at approximately 2 weeks (for the optional touch-up treatment) and 2 
months (for the final study visit). Study participants will be contacted by telephone within 24 hours 
following each procedural visit to assess for the occurrence of any AEs or concerns. 
At the end of the study, if a study participant is dissatisfied with the outcomes of the treatment, they 
will be offered a complimentary consultation visit with the principal investigator to discuss their 
aesthetic results and options for cosmetic treatment. Any treatments or procedures that the 
participant wishes to pursue will be outside of the scope of this research study. The optional 2 
week touch-up visit is offered to assess the results and administer additional injections, as 
requested by the participant or recommended by the clinician, to achieve the desired aesthetic 
outcomes. No additional touch-up treatments will be administered as part of the research study. 
Participants who wish to receive facial cosmetic treatments or procedures following the conclusion 
of the study will be allowed to do so at their own expense, at the facility or provider of their choosing. 
DURATION OF STUDY 
Study duration is approximately 2 months from the baseline visit to the final follow-up study visit. 
 
 


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HUMAN RESEARCH CONSIDERATIONS 
RECRUITMENT PROCEDURES 
Potential study participants may be recruited through the following methods: 
• 
IRB-approved flyers at SUNY Downstate Medical Center 
• 
Websites: SUNY Downstate Department of Dermatology, SUNY Downstate Clinical 
and Translational Science Center, StudyPages.com 
• 
Social media  
Recruitment materials will be distributed or made available to the general public. Potential 
participants may inquire about the study by contacting the research team directly. 
At the initial screening visit, the research team will explain the study, provide relevant literature and 
information, and answer all questions. Written informed consent will be obtained prior to any study-
related procedures or interventions. We will indicate that the subjects will receive the same 
standard of clinical care options regardless of whether they decide to participate in the study. 
Subjects will be informed that participation is voluntary, allowing them to withdraw from the study 
at any time. 
RISKS/DISCOMFORTS 
The potential risks associated with participation in the research study can be categorized as 
follows: 
Physical Risks 
Procedure-related potential side effects 
• 
Injection site ecchymoses 
• 
Injection site discomfort  
• 
Injection site erythema  
• 
Edema 


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• 
Post-inflammatory hypopigmentation and/or 
hyperpigmentation  
Product-related potential 
side effects 
General 
• 
Pruritus 
• 
Burning  
• 
Irritation 
• 
Erythema 
• 
Rash 
• 
Injection site induration 
• 
Injection site granuloma  
• 
Edema 
Botox 
Cosmetic 
• 
Facial pain 
• 
Eyelid ptosis  
• 
Eyelid edema 
• 
Brow ptosis 
• 
Vision changes 
• 
Eye discomfort or irritation  
• 
Muscle weakness 
• 
Headache 
• 
Neck pain 
• 
Skin tightness 
Juvéderm 
Volbella XC 
• 
Injection site nodules  
• 
Allergic reaction  
• 
Discoloration  
• 
Hardening of the skin 
• 
Headache 
• 
Swelling of the side of the nose 
• 
Lip numbness 
• 
Lip dryness 
• 
Mild herpes simplex virus  
• 
Moderate cold sores 
• 
Rare but serious adverse events associated 
with intravascular injection of soft tissue 
fillers in the face have been reported and 
include temporary or permanent vision 
impairment (including blindness) and 


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cerebral ischemia or hemorrhage. 
Intravascular injection can lead to stroke, 
skin necrosis, and damage to underling 
facial structures.  
Juvéderm 
Voluma XC 
• 
Injection site nodules 
• 
Rare but serious adverse events associated 
with intravascular injection of soft tissue 
fillers in the face have been reported and 
include temporary or permanent vision 
impairment (including blindness) and 
cerebral ischemia or hemorrhage. 
Intravascular injection can lead to stroke, 
skin necrosis, and damage to underling 
facial structures. 
Hyaluronidase (reversal agent) 
• 
Injection site reactions such as erythema 
(redness) and pain 
• 
Edema (swelling) 
• 
Hyaluronidase has been reported to 
enhance the adverse reactions associated 
with co-administered drug products 
 
Social/Psychological Risks 
• 
Dissatisfaction with outcomes of the facial aesthetic treatment 
• 
Boredom during study visits 
• 
Discomfort answering satisfaction questionnaires 
Confidentiality Risks  
• 
Breach of privacy (e.g., protected health information) 
Economic Risks 
• 
Loss of time and potential income by attending study visits 
 


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POTENTIAL BENEFITS 
There are no direct benefits from participating in this research study. Potential benefits associated 
with participation in this study may include: 
• 
Satisfaction with aesthetic results  
• 
Improvement in self-esteem and confidence  
• 
Improvement in quality of life  
 
PARTICIPANT REIMBURSEMENT AND PAYMENTS 
Subjects will be compensated for study participation. Up to $150 will be given in the form of 
check(s) distributed by the SUNY Downstate Research Foundation. Participants will receive $50 
for the baseline visit and $100 for the final follow-up visit, for a maximum total amount of $150 for 
completing the entire study.  
 
INFORMED CONSENT 
A consent form describing the study intervention, study procedures, and risks will be given to the 
potential participant at the screening visit. All subjects must provide written informed consent will 
before any study related procedures are performed. 
  
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be IRB-
approved and the participant will be asked to read and review the document. The investigator will 
explain the research study to the participant and answer any questions that may arise. A verbal 
explanation will be provided in terms suited to the participant’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants.  Participants 
will have the opportunity to carefully review the written consent form and ask questions prior to 
signing. The participants should have the opportunity to discuss the study with their family or 
surrogates or think about it prior to agreeing to participate. The participant will sign the informed 
consent document prior to any procedures being done specifically for the study. Participants will 


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be informed that participation is voluntary and that they may withdraw from the study at any time, 
without prejudice. A copy of the informed consent document will be given to the participants for 
their records. The informed consent process will be conducted and documented in the source 
document (including the date), and the form signed, before the participant undergoes any study-
specific procedures. The rights and welfare of the participants will be protected by emphasizing to 
them that the quality of their medical care will not be adversely affected if they decline to participate 
in this study.   
CONFIDENTIALITY 
Participant confidentiality and privacy is strictly held in trust by the investigators, key study 
personnel, and the research grant provider. Therefore, the study protocol, documentation, data, 
and all other information generated will be held in strict confidence. No information concerning the 
study or the data will be released to any unauthorized third party. 
All research activities will be conducted in as private a setting as possible. The study subject’s 
contact information will be securely stored at each clinical site for internal use during the study. At 
the end of the study, all records will continue to be kept in a secure location for as long a period as 
dictated by the IRB, SUNY Downstate institutional policies, or research grant provider 
requirements. 
 
The study monitor, representatives of the IRB, or regulatory agencies may inspect all documents 
and records required to be maintained by the investigator, including but not limited to, medical 
records (office, clinic, or hospital) and pharmacy records for the participants in this study. The 
clinical study site will permit access to such records. 
Study subject research data, which is for purposes of statistical analysis and scientific reporting, 
will be managed and protected in accordance with SUNY Downstate Medical Center Human 
Research Protections Program. This will not include any participant’s contact or identifying 
information. Rather, individual participants and their research data will be identified by a unique 
study identification number. Written individual or aggregate data from the study will be secured in 
a locked cabinet in a locked room. Computerized data will be stored on the HIPAA-compliant SUNY 
Downstate Department of Dermatology desktop computers that are connected to the SUNY 
Downstate Medical Center’s secure network behind a firewall, complete with 128-bit data 


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encryption. Storage of any PHI on a laptop or portable device (e.g., external drive, flash drive, 
CD/DVD, USB drive or similar) will be encrypted and used only for temporary storage. In addition 
to being encrypted, removable storage devices will be stored in a locked cabinet or drawer when 
not in use.  
DATA AND SAFETY MONITORING 
The safety of research participants will be monitored according to standard clinical practice for 
outpatient cosmetic procedures involving facial injectables. The products in this study (Botox 
Cosmetic, Juvéderm Voluma XC, and Juvéderm Volbella XC) will be used in accordance to their 
FDA-approved indications. All AEs, SAEs, and unanticipated problems will be recorded in the 
appropriate case report forms and reported to the safety monitor (Dr. Edward Heilman) within 24 
hours of the occurrence. The safety monitor is not a member of the research team and has no 
relevant conflicts of interest. 
The research team will reported to Allergan Medical Affairs all SAEs within 24 hours after its first 
knowledge of the SAE in accordance with the SAE Report Form by emailing aus-
psreporting@allergan.com or DL-AUS-PS1stLine@allergan.com and calling 1-800-678-1605. The 
SAE Report Form shall include an assessment of the causal relationship between the Allergan 
products and the SAE. 
DISCONTINUATION OF RESEARCH PARTICIPANTS/WITHDRAWAL 
Participation in the study is voluntary. A subject has the right to withdraw from the study at any 
time for any reason, without prejudice, and is under no obligation to disclose the reason. 
The research team may consider discontinuing a subject from the study for the following reasons: 
• 
Major protocol violation or deviation (e.g., significant non-compliance with the study 
procedures) 
• 
Any clinical AE or other medical condition or situation occurs such that continued 
participation in the study would not be in the subject’s best interest 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
• 
Unforeseen serious AE occurs 


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The reason for a subject’s discontinuation or withdrawal from the study will be recorded on the 
appropriate case report form, if applicable. 
AEs, SAEs, and unanticipated problems will be monitored, and the trial will be halted early if 
necessary, to protect subjects. Any life-threatening events and/or deaths attributable to the study 
protocol will result in halting the study. 
RECORD RETENTION 
Study documents will be securely maintained to protect confidentiality and privacy in accordance 
with SUNY Downstate policies. According to the minimum retention periods required by 
Downstate, research records collected by investigators will be maintained for at least three years, 
and up to 10 years as practicable, after completion of the research. Study participants’ signed 
HIPAA Research Authorization forms will be kept for a minimum of six years after such 
authorization last was in effect. Research records will not be destroyed unless in conformity with 
Downstate policies and requirements of the research grant provider. 
CONFLICT OF INTEREST 
The principal investigator has no relevant conflicts of interest to disclose. 
REPORTABLE EVENTS 
As required by Policy IRB-01, all reportable events will be reported to the IRB within the specified 
deadlines.  Additional information is provided in the IRB Guidance on “Reportable Events.”  Events 
are defined in the IRB Guidance on “Acronyms and Definitions.” For additional information see: 
http://research.downstate.edu/irb/irb-policies.html  
REFERENCES/BIOGRAPHY 
1. Dimock M. Defining generations: Where Millennials end and post-Millennials begin. Pew 
Research Center. http://pewrsr.ch/2GRbL5N. Published March 2018. Accessed July 22, 
2019. 
2. Allergan plc. 2018 Allergan 360°: Aesthetics Report. https://360aestheticsreport.com/view-
report/. Accessed July 22, 2019.  


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3. American Academy of Facial Plastic and Reconstructive Surgery. AAFPRS 2018 Annual 
Survey. https://www.aafprs.org/media/stats_polls/m_stats.html. Accessed July 22, 2019. 
4. American Society of Plastic Surgeons. 2018 National Plastic Surgery Statistics. 
https://www.plasticsurgery.org/documents/News/Statistics/2018/plastic-surgery-statistics-
report-2018.pdf. Accessed July 22, 2019.  
5. Campbell 
C. 
What 
is 
Prejuvenation? 
Preventative 
Botox 
and 
Injectables. 
https://zalea.com/article/prejuvenation-botox-injectables-antiaging/17035. 
Published 
December 2017. Accessed July 22, 2019  
6. Hilton L. Examining the prejuvenation trend. https://www.dermatologytimes.com/facial-
aesthetics/examining-prejuvenation-trend. Published April 2019. Accessed July 22, 2019.  
7. Carruthers A, Carruthers J. Botulinum toxin type A: History and current cosmetic use in the 
upper face. Semin Cutan Med Surg. 2001;20:71-84. 
8. Humphrey S. Neurotoxins: Evidence for prevention. Journal of Drugs in Dermatology. 
2017;16(6 Suppl):s87-90. 
9. Rivkin, A., Binder, W. Long-term effects of onabotulinumtoxinA on facial lines: a 19-year 
experience of identical twins. Dermatologic Surgery, 41, S64-S66.  
10. Dailey R., Philip A., Tardie G. Long-term treatment of glabellar rhytides using 
onabotulinumtoxinA. Dermatologic Surgery. 2011;37:918-28.  
11. Anand C. Facial contouring with fillers, neuromodulators, and lipolysis to achieve a natural 
look in patients with facial fullness. Journal of Drugs in Dermatology. 2016 Dec 
1;15(12):1536-1542.  
12. Narurkar V. A Comprehensive Approach to Multimodal Facial Aesthetic Treatment: 
Injection Techniques and Treatment Characteristics From the HARMONY Study. 
Dermatologic Surgery. 2016 May; 42 Suppl 2:S1777-91.   
13. Furnham A. Factors that motivate people to undergo plastic surgery. Canadian Journal of 
Plastic Surgery. 2012 Winter; 20(4): e47-e50.  
14. Tennant A, Conaghan PG. The Rasch measurement model in rheumatology: what is it and 
why use it? When should it be applied, and what should one look for in a Rasch paper? 
Arthritis Rheum. 2007;57(8):1358-1362. 
15. Pallant JF, Tennant A. An introduction to the Rasch measurement model: an example using 
the Hospital Anxiety and Depression Scale (HADS). Br J Clin Psychol. 2007;46(Pt 1):1-18. 
 
 


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TABLE 1. SCHEDULE OF ASSESSMENTS 
 
 
Screening† 
Baseline Visit† 
(Procedure) 
2 Week Touch-Up 
Visit  
(optional) 
2 Month Follow-Up 
Visit 
(End of Study) 
Informed consent 
X 
 
 
 
Inclusion/exclusion 
X 
 
 
 
Demographics 
X 
 
 
 
Medical history 
X 
 
 
 
Concomitant medications 
X 
X 
X 
X 
Facial aesthetic treatment 
 
X 
X 
 
Photography 
 
X 
X 
X 
Clinical evaluation 
 
X 
 
X 
Satisfaction questionnaires 
 
X 
 
X 
Safety and tolerability 
 
X 
X 
X 
Adverse events 
 
X 
X 
X 
Exit survey 
 
 
 
X 
 
† The screening visit and the baseline visit may occur on the same day, depending on the 
preferences of the participant and scheduling considerations by the research team.