A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing
Phase: PHASE3
Conditions: Temple Hollowing
Sponsor: Allergan

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Title Page 
Protocol Title: A multicenter, evaluator-blinded, randomized, parallel-group, controlled study of 
the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel for correction of 
temple hollowing  
Protocol Number: 1878-702-008 Amendment 2 
Product: JUVÉDERM VOLUMA® XC injectable gel 
Brief Protocol Title: JUVÉDERM VOLUMA® XC injectable gel for correction of temple 
hollowing  
Study Phase: Pivotal  
Sponsor Name: Allergan 
Legal Registered Address:  
Allergan Sales LLC 
5 Giralda Farms  
Madison, NJ 07940 
USA  
Manufacturer: 
Allergan 
Route de Proméry 
Zone Artisanale de Pré-Mairy, Pringy 
Annecy, 74370  
France 
Regulatory Agency Identifying Numbers: IDE G190158 and NCT04414397  
Emergency Telephone Number: 
 
Refer to the study contacts page 
SAE Reporting Fax Number/Email: 
LC-Medical_Safety@Allergan.com  
+1-877-605-4524 or +1-714-796-9567
Sponsor Signatory: 
 
Vice President 
Global Therapeutic Area Head, Clinical Development, Aesthetics 
Refer to the final page of this protocol for electronic signature and date of approval. 
 
 
 
 
Date: 10 May 2021
NCT04414397

 
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Objectives 
Endpoints 
Effectiveness 
To evaluate the 
effectiveness of 
VOLUMA XC injectable 
gel in adult participants 
seeking correction of 
temple hollowing 
• 
Primary: Responder status based on the evaluating investigator’s (EI) live 
assessment of temple hollowing using the Allergan Temple Hollowing Scale 
(ATHS) at Month 3 
• 
Secondary: Responder status based on EI assessments of global aesthetic 
improvement in the temple area using the Global Aesthetic Improvement Scale 
(GAIS) at Month 3 
• 
Secondary: Responder status based on participant assessments of global 
aesthetic improvement in the temple area using the GAIS at Month 3 
• 
Secondary: Change from baseline on FACE-Q Satisfaction with Facial 
Appearance questionnaire at Month 3 
• 
Secondary: Change from baseline on FACE-Q Satisfaction with Temples 
questionnaire at Month 3 
Safety 
To evaluate the safety of 
VOLUMA XC injectable 
gel in adult participants 
seeking correction of 
temple hollowing 
• 
Participant assessment of procedural pain 
• 
Participant assessment of injection site responses 
• 
Adverse events 
• 
Jaw Functional Limitation Scale 
• 
Vision Assessments:  
- Snellen visual acuity 
- confrontational visual fields 
- ocular motility 
• 
Concomitant medication and procedures 
Overall Study Design:   
• Multicenter, randomized, controlled, parallel-design study in participants with minimal, 
moderate, or severe temple hollowing (Grade 2, 3, or 4 on the ATHS) 
• Single-blind: EIs are blinded; treating investigators (TIs) and participants are not blinded 
• VOLUMA XC injected with 27 G 1/2” or 25 G 1” needles to the supraperiosteal plane in the 
temple area (up to 6 mL for initial and touch-up treatments combined) for the treatment 
group and delayed treatment for the control group 
Number of Participants:   
Up to 213 participants will be enrolled and screened to achieve 171 randomized (114 treatment 
group, 57 control group) and 135 evaluable participants (90 treatment group, 45 control group) at 
the Month 3 primary timepoint. 
Number of Sites:   
Up to 15 North American sites  
Intervention Groups and Study Duration:   
• Participants will be randomized on study intervention day in a 2:1 ratio of treatment group 
to control group. Screening period is up to 30 days for all participants. 

 
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a month = 30 days 
a A maintenance treatment is offered to participants who complete the Month 13 visit. The procedures must occur no later than 
14 days after the Month 13 visit.  
b Follow-up visit schedule is based on the date of the last study intervention (ie, maintenance treatment).  
c If a participant withdraws for any reason prior to the final study visit, attempts will be made to perform assessments at an exit 
visit.  
d For female participants of childbearing potential. A female is not considered of childbearing potential if she has been 
postmenopausal for at least 1 year or does not have a uterus at the time of study entry.  
e Administered and confirmed negative prior to study intervention. If maintenance treatment is done on the same day of the 
Month 13 visit, this assessment does not need to be repeated.  
f Prior to maintenance treatment. If maintenance treatment is done on the same day of the Month 13 visit, this assessment does 
not need to be repeated.  
g Vision assessments will be performed by TI (or designee) before study intervention and at least 30 minutes after completing 
the injection procedures.  
h The safety e-diaries are to be completed following each study intervention starting on the day of treatment.  
i Will include a general, nondirected question about vision symptoms.  
 

 
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3. 
Objectives and Endpoints 
The objectives of this study are to evaluate the safety and effectiveness of VOLUMA XC 
injectable gel in adult participants seeking correction of temple hollowing. 
Objectives 
Endpoints 
Effectiveness 
To evaluate the 
effectiveness of 
VOLUMA XC injectable 
gel in adult participants 
seeking correction of 
temple hollowing 
• 
Primary: Responder status based on EI’s live assessment of temple hollowing 
using the ATHS at Month 3 
• 
Secondary: Responder status based on EI assessments of global aesthetic 
improvement in the temple area using the GAIS at Month 3 
• 
Secondary: Responder status based on participant assessments of global 
aesthetic improvement in the temple area using the GAIS at Month 3 
• 
Secondary: Change from baseline on FACE-Q Satisfaction with Facial 
Appearance questionnaire at Month 3  
• 
Secondary: Change from baseline on FACE-Q Satisfaction with Temples 
questionnaire at Month 3 
 
  
 
  
 
 
Safety 
To evaluate the safety of 
VOLUMA XC injectable 
gel in adult participants 
seeking correction of 
temple hollowing 
• 
Participant assessment of procedural pain 
• 
Participant assessment of ISRs 
• 
AEs 
• 
Jaw Functional Limitation Scale  
• 
Vision Assessments:  
- Snellen visual acuity 
- confrontational visual fields 
- ocular motility 
• 
Concomitant medications and procedures 
 

 
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4. 
Study Design 
4.1. 
Overall Design 
The design elements of this protocol have been reviewed with patients to obtain their 
perspectives in the following areas: schedule of events, length of study and visits, randomization 
ratio and duration of control period, and ICF language on possible adverse events.  
This is a prospective, multicenter, evaluator-blinded, randomized, parallel-group, controlled 
study to evaluate the safety and effectiveness of VOLUMA XC injectable gel to correct temple 
hollowing.  
The study will involve up to 15 investigational sites. The study population is represented by 
adults who are seeking correction of the temple hollowing and who meet the study criteria 
according to the study design. 
Participants will be randomized on study intervention day in a 2:1 ratio of treatment group to 
control group.  
Participants will stay in the study for up to 21 months depending on their randomization group. 
For the treatment group, each participant will be in the study for up to 21 months: up to 1 month 
for screening, up to 30 days of treatment, up to 13 months of follow-up after initial/touch-up 
treatment, and up to 6 months of follow-up after maintenance treatment. For the control group, 
each participant will be in the study for up to 4 months (up to 1 month for screening and 
3 months for follow-up) and then may exit or opt to receive study intervention. Control 
participants who opt to receive study intervention will be in the study for an additional 
14 months (up to 30 days for treatment and 13 months of follow-up), for a total of up to 
18 months. 
 
Treatment Group 
Control Group 
Screening 
Up to 1 month 
Up to 1 month 
Control period 
Not Applicable 
3 Months 
Treatment period 
1-30 Days 
1-30 Days (optional) 
Treatment follow-up period 
13 Months 
13 Months 
Maintenance treatment 
1 Day (optional) 
Not Applicable 
Maintenance treatment follow-up 
6 Months 
Not Applicable 
 
The study will compare the treatment to no treatment, with the primary timepoint set at Month 3.  

 
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5. 
Study Population 
Adults with temple hollowing who are seeking restoration in the temple area. 
 
 
 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. 
Age 
1.01 
Participant must be 22 or over, at the time of signing the ICF 
2. 
Sex 
2.01 
Male and female 
3. 
Type of Participant and Temple Hollowing Characteristics 
3.01 
Participants in general good health 
3.02 
Participants seeking improvement of temple hollowing 
3.03 
Has Minimal, Moderate, or Severe temple hollowing (Grade 2, 3, or 4 on the ATHS) for each temple on EI 
live assessment (both temples must qualify but do not need to have the same score) 
3.04 
The temple hollowing is amenable to temporary correction in the TI’s opinion 
4. 
Informed Consent 
4.01 
Capable of giving signed informed consent as described in Appendix 10.1.3, which includes compliance 
with the requirements and restrictions listed in the ICF and in this protocol 
4.02 
Written informed consent from the participant has been obtained prior to any study-related procedures 
4.03 
Written documentation has been obtained in accordance with the relevant country and local privacy 
requirements, where applicable 
5. 
Other 
5.01 
Able, as assessed by the TI, and willing to follow study instructions (including compliance with the safety 
e-diary) and likely to complete all required study visits 
5.02 
Is able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable 
if they will be used for all participant self-assessments) 
5.03 
Fluent and literate in English or Spanish 
 

 
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5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. 
Medical Conditions 
1.01 
The participant cannot achieve at least a 1-grade improvement for each temple from the EI’s baseline 
score on the ATHS given the allowed injection volume, in the opinion of the TI 
1.02 
Has temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or 
acquired 
Additional examples include: congenital myotonic dystrophy, HIV-associated lipodystrophy, or acquired 
generalized lipodystrophy 
1.03 
Has experienced trauma to the temple area within 6 months before enrollment or has residual 
deficiencies, deformities, or scarring 
1.04 
Atrophic skin in the temple area that might not be suitable for injection, in the opinion of the TI 
1.05 
Temporal artery runs across the area to be injected, obscuring the field 
1.06 
Temporal arteritis or history of temporal arteritis 
1.07 
Temporomandibular joint dysfunction or any other jaw issues 
1.08 
Recurrent temporal headaches such as temporal tendinitis migraine 
1.09 
Active or recurrent inflammation or infection in either eye 
1.10 
Tendency to develop hypertrophic scarring 
1.11 
Active autoimmune disease 
1.12 
History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or 
Streptococcal protein 
1.13 
Current cutaneous or mucosal inflammatory or infectious processes (eg, acne, herpes), abscess, an 
unhealed wound, or a cancerous or precancerous lesion, above the subnasale 
1.14 
History of detached retina, retinal vascular occlusion (eg, vein or arterial occlusion), narrow angle 
glaucoma, neovascular eye disease, or severely impaired/absent eye function in 1 or both eyes 
Examples of neovascular eye disease include: diabetic retinopathy, age-related wet macular degeneration 
2. 
Prior/Concomitant Therapy 
2.01 
Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area 
(eg, biopsy) 
2.02 
Fat injection or permanent facial implants (eg, polymethylmethacrylate, silicone, 
polytetrafluoroethylene) anywhere in the face  
2.03 
Semipermanent soft-tissue filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) in the temple 
or mid-face within 36 months before enrollment 
2.04 
Temporary dermal filler injections above the subnasale within 24 months before enrollment 
Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment 
2.05 
Botulinum toxin treatment above the subnasale within 6 months before enrollment  
2.06 
Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment 
Examples of mesotherapy or cosmetic facial procedures are face-lift, laser, photomodulation, intense 
pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative 
procedures 

 
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2.07 
Has braces or other orthodontics or is planning such treatment during the study  
2.08 
Changes in use of over-the-counter or prescription oral or topical, anti-wrinkle products above the 
subnasale within 30 days before enrollment or planned changes during the study 
Participants are not eligible for this study if they have begun using any new over-the-counter or 
prescription oral or topical, anti-wrinkle products above the subnasale within 30 days before enrollment 
or are planning to begin using such products during the study. Participants who have been on a regimen 
of such products for at least 30 days are eligible for the study if they intend to continue their regimen 
throughout the study 
2.09 
Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel) 
2.10 
Has received lasik surgery or other surgical intervention on the eye within 3 months prior to enrollment 
or is planning such a procedure 
3. 
Prior/Concurrent Clinical Study Experience 
3.01 
Current enrollment in an investigational drug or device study or participation in such a study within 
30 days of entry into this study 
4. 
Other 
4.01 
Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with 
visual assessment of the temple 
4.02 
Females who are pregnant, nursing, or planning a pregnancy 
4.03 
TI’s discretion based on participant’s safety and/or study integrity 
The participant has a condition or is in a situation that, in the TI’s opinion, may put the participant at 
significant risk, may confound the study results, or may interfere significantly with the participant’s 
participation in the study 
4.04 
Directly or indirectly involved in the conduct and administration of this study 
Directly or indirectly involved in the conduct and administration of this study as an investigator, 
subinvestigator, study coordinator, or other study staff member; employee of the sponsor; first-degree 
family member, significant other, or relative residing with one of the above persons involved directly or 
indirectly in the study; or enrolled in the study at another clinical site 
4.05 
Plans a significant weight change (more than 10% of body weight) during the study 
 
5.3. 
Lifestyle Considerations 
Within the first 24 hours after study intervention, it is recommended that participants avoid 
strenuous exercise, extensive sun or heat exposure, and alcoholic beverages. Exposure to any of 
the above may cause temporary redness, swelling, and/or itching at the injection sites. 
For 2 days after study intervention, it is recommended that participants avoid unnecessary 
external compression of the treatment site that could cause displacement or indentation where the 
product has been placed. Participants will be advised not to have a massage, enter a hot spring or 
sauna, receive excessive sun exposure, or go swimming during the week following any study 
intervention. 

 
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Table 6-2 
Required Washout Intervals for Prohibited Medications or Procedures 
Washout Period 
Medication or Procedure 
10 days  
• Ongoing regimen of medications and/or substances known to increase coagulation time 
(eg, aspirin, ibuprofen, or herbal supplements) 
 
NOTE:  The 10-day washout period must continue for 3 days after study intervention (initial, 
touch-up, and maintenance) is administered. 
30 days  
• Any investigational product 
• Any new over-the-counter or prescription oral or topical, anti-wrinkle products above the 
subnasale 
6 months 
• Botulinum toxin injections above the subnasale 
• Mesotherapy or cosmetic facial procedures (eg, face-lift, laser, photomodulation, intense 
pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or 
other ablative procedures) above the subnasale 
3 months 
• Temporary dermal filler injections in the nasolabial folds 
• Lasik surgery or other surgical intervention at the eye 
24 months 
• Temporary dermal filler injections above the subnasale 
36 months 
• Semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) in 
the temple or mid-face 
 
6.5.2. 
Permitted Interventions 
All interventions are permitted except those listed as prohibited in Section 6.5.4. Topical or 
injectable anesthesia may be used during treatment according to routine practice, but it must be 
limited to the treatment areas only. 
Therapy considered necessary for the participant’s welfare may be given at the discretion of the 
investigator. If the permissibility of a specific medication/intervention is in question, please 
contact the sponsor. 
The sponsor or designee is to be contacted if there are any questions regarding concomitant or 
prior therapy. 
6.5.3. 
Rescue Medicine 
Rescue medicine is not applicable. 

 
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7. 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal 
A premature discontinuation will occur if a participant who signs the ICF and receives study 
intervention ceases participation in the study, regardless of circumstances, before the completion 
of the protocol-defined study procedures. 
Notification of early participant discontinuation from the study and the reason for 
discontinuation will be made to the sponsor and will be clearly documented on the appropriate 
case report form. 
Reasons for discontinuation from the study intervention and/or the study may include the 
following commonly used or other acceptable terms: 
Commonly Used Terms 
Other Acceptable Terms 
Adverse event 
Death 
Completed 
 
Lost to follow-up 
 
Other 
 
Physician decision 
 
Protocol deviation 
 
Screen failure 
 
Site terminated by sponsor 
 
Study terminated by sponsor 
 
Withdrawal by participant 
 
 
7.1. 
Discontinuation of Study Intervention 
Pregnancy will discontinue a participant from receiving further study intervention. If a 
participant has a positive urine pregnancy test prior to randomization, the participant will be 
considered a screen failure. Participants who become pregnant or have a positive urine 
pregnancy test and have already been randomized will continue in the study until all required 
follow-up is complete, but they will not be eligible for further study intervention. 
In addition, participants who receive the following prohibited treatment/medication will continue 
in the study until all required follow-up is complete but will not be eligible for further study 
intervention. 
• Hyaluronidase treatment in the temple area 
• Initiate a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)  

 
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Table 8-2 
Global Aesthetic Improvement Scale 
Score 
Grade 
Description 
2 
Much Improved 
Marked improvement in appearance 
1 
Improved 
Improvement in appearance, but a touch-up or retreatment is indicated 
0 
No Change 
The appearance is essentially the same as the original condition 
-1 
Worse 
The appearance is worse than the original condition 
-2 
Much Worse 
The appearance is much worse than the original condition 
 
Participants and EIs will assess global aesthetic improvement of the temple area by comparing to 
frontal and lateral view photographs taken at baseline. Participants will use a mirror to assess 
their current appearance at each visit. All participant-reported effectiveness outcomes at a visit 
will be completed before the participant sees either the TI or EI at that visit. 
The other secondary effectiveness measures are the participant responses on the FACE-Q 
questionnaires: Satisfaction with Facial Appearance and Satisfaction with Temples. In the 
FACE-Q Satisfaction with Facial Appearance questionnaire the responses to the 10 items will be 
summed and converted to a Rasch-transformed score that ranges from 0 to 100 (higher score 
indicates increased satisfaction) using the algorithm developed by the FACE-Q scale developers. 
In the FACE-Q Satisfaction with Temples questionnaire, the final scoring and items will be 
determined based on the analysis of psychometric properties of the scale (as discussed in 
Section 4.2.4) and will be specified in the SAP.  
 
 
 
 
 
 
 

 
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10.4. 
Appendix 4: Abbreviations 
Abbreviation 
Definition 
3D 
3-dimensional 
AE 
adverse event 
AESI 
adverse event of special interest 
ATHS 
Allergan Temple Hollowing Scale 
BP 
blood pressure 
CDISC 
Clinical Data Interchange Standards Consortium 
CE 
Conformité Européene 
DFU 
directions for use 
eCRF 
electronic case report form 
EI 
Evaluating Investigator 
GAIS 
Global Aesthetic Improvement Scale 
HA 
hyaluronic acid 
HIV 
human immunodeficiency virus 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IDE 
investigational device exemption 
IRB 
institutional review board 
ISO 
International Organization for Standardization 
ISR 
injection site response 
IWRS 
interactive web response system 
mITT 
modified intent-to-treat 
NCI 
National Cancer Institute 
NCT 
national clinical trial number on www.clinicaltrials.gov 
PI 
Principal Investigator 
PT 
preferred term 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SoA 
schedule of activities 
SOC 
system organ class 
TEAE 
treatment-emergent adverse event 
TESAE 
treatment-emergent serious adverse event 
TI 
Treating Investigator 
 

 
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10.5. 
Appendix 5: Standard Discontinuation Criteria 
This table provides participant discontinuation criteria for this protocol. CDISC terminology is 
used, and thus subject or patient is used instead of participant (as used elsewhere in this 
protocol). These terms are interchangeable.  
CDISC 
Submission 
Value 
CDISC Definition 
Adverse event 
Any untoward medical occurrence in a patient or clinical investigation subject administered a 
pharmaceutical product and which does not necessarily have a causal relationship with this 
treatment. An AE can therefore be any unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a medicinal 
(investigational) product, whether or not related to the medicinal (investigational) product. For 
further information, see the ICH Guideline for Clinical Safety Data Management: Definitions 
and Standards for Expedited Reporting (modified from ICH E2A) Synonyms: side effect, 
adverse experience. See also serious adverse event, serious adverse experience. (CDISC 
glossary) 
Completed 
To possess every necessary or normal part or component or step; having come or been brought 
to a conclusion (NCI) 
Death 
The absence of life or state of being dead (NCI) 
Lost to follow-
up 
The loss or lack of continuation of a subject to follow-up 
Other 
Different than the one(s) previously specified or mentioned (NCI) 
Physician 
decision 
A position, opinion, or judgment reached after consideration by a physician with reference to 
subject (NCI) 
Protocol 
deviation 
An event or decision that stands in contrast to the guidelines set out by the protocol (NCI) 
Screen failure 
The potential subject who does not meet one or more criteria required for participation in a trial 
Site terminated 
by sponsor 
An indication that a clinical study was stopped at a particular site by its sponsor (NCI) 
Study 
terminated by 
sponsor 
An indication that a clinical study was stopped by its sponsor (NCI) 
Withdrawal by 
subject 
An indication that a study participant has removed itself from the study (NCI) 
 

 
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Parameter 
Group 
Parameter 
Value 
Trial 
design 
Study Type 
Interventional 
Intervention Model 
Parallel 
Planned Number of Arms 
2 
Trial Is Randomized 
Yes 
Randomization Quotient 
2:1 
Trial Blinding Schema 
Single blind 
Stratification Factor 
None 
Adaptive Design 
No 
Study Stop Rules 
Yes 
 
 

 
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10.8. 
Appendix 8: Amendment 1 Summary of Changes 
Amendment 1 (January 2020) 
Overall Rationale for the Amendment: 
Minor clarifications 
Section # and Name 
Description of Change 
Brief Rationale 
Table 1-6 Control Group 
Procedures: Delayed 
Treatment Period 
Added to footnote d that a urine pregnancy test is 
among the assessments to be conducted for 
participants exiting the study prior to Month 6 
To provide for pregnancy 
testing prior to study exit 
5.2 Exclusion Criteria 
Corrected exclusion criterion 4.02 to remove 
“not” and corrected numbering of exclusion 
criteria 
To correct typo and 
formatting 
8.1.3 Secondary 
Effectiveness Measures 
Changed GAIS assessments from profile view 
photographs to frontal and lateral view 
photographs 
To allow more complete 
views of the temple area in 
GAIS assessments