JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population

Study Overview
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Brief Summary
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The objectives of this study are to evaluate the safety and effectiveness of JUVÉDERM®VOLUMA® with Lidocaine injectable gel in adult Chinese population seeking correction of temple hollowing.

Official Title
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A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population

Conditions
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Temple Hollowing

Intervention / Treatment
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* Device: JUVÉDERM® VOLUMA® with Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be 18 or over, at the time of signing the ICF Participants seeking improvement of temple hollowing Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol Written informed consent from the participant has been obtained prior to any study-related procedures Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable 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) Exclusion Criteria: Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired Has experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring Temporal arteritis or history of temporal arteritis Temporomandibular joint dysfunction or any other jaw issues Recurrent temporal headaches such as temporal tendinitis migraine Active or recurrent inflammation or infection in either eye Tendency to develop hypertrophic scarring Active autoimmune disease History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein Current cutaneous or mucosal inflammatory or infectious processes (e.g. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, above the subnasal Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy) Fat injection or permanent facial implants anywhere in the face Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment Temporary dermal filler injections above the subnasale within 12 months before enrollment Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment (examples of mesotherapy or cosmetic facial procedures are laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures. Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment Botulinum toxin treatment above the subnasale within 6 months before enrollment Has braces or other orthodontics Not eligible for this study if participants have begun using any new over the counter or prescription oral or tropical, anti-wrinkle products above the subnasale within 30 days before enrollment. 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 Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel) Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with visual assessment of the temple Females who are pregnant, nursing, or planning a pregnancy Plans a significant weight change (more than 10% of body weight) during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JUVÉDERM® VOLUMA® with Lidocaine<br>Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch up treatment | Device: JUVÉDERM® VOLUMA® with Lidocaine<br>* JUVÉDERM® VOLUMA® with Lidocaine injectable gel<br>|
| No Intervention: Control- No treatment<br>No treatment is administered. Optional treatment at month 6. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. | Up to 14 Months | 
| Participants with at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) using the Allergan Temple Hollowing Scale (ATHS) | The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement. | Change from Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on FACE-Q Satisfaction with Temples questionnaire at Month 6 | 16-item questionnaire assessing satisfaction with various aspects of facial appearance. Participants respond to each item as: 1 Very Dissatisfied, 2 Somewhat Dissatisfied, 3 Somewhat Satisfied, 4 Very Satisfied. | Change from Baseline to Month 6 | 
| Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 6 | 10-item questionnaire assessing satisfaction with various aspects of facial appearance. Participants respond to each item as: 1 Very Dissatisfied, 2 Somewhat Dissatisfied, 3 Somewhat Satisfied, 4 Very Satisfied. | Change from baseline to Month 6 | 
| Participants Improved or Much Improved as self-assessed by participant using the Global Aesthetic Improvement Scale (GAIS) | Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. | Month 6 | 
| Participants Improved or Much Improved as assessed by the Evaluating Investigator using the Global Aesthetic Improvement Scale (GAIS) | The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. | Month 6 |