Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing

Study Overview
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Brief Summary
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This study will evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC injectable gel in adult participants seeking correction of temple hollowing.

Official Title
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A Multicenter, Single-Blind, Randomized, Parallel-Group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing

Conditions
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Temple Hollowing

Intervention / Treatment
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* Device: Juvéderm® VOLUMA XC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Has temple hollowing and is seeking restoration in the temple area. Exclusion Criteria: Has temple hollowing due to due to trauma, congenital malformations, or lipodystrophy Has received permanent facial implants in the face or neck Has undergone fat injections Has tattoos, piercings, facial hair or scars that would interfere with visual assessment of the temple Has undergone semipermanent dermal filler treatment in the temple or mid-face within the past 36 months Has undergone dermal filler injections above the subnasale within the past 24 months Has temporal arteritis or history of temporal arteritis Has temporomandibular joint dysfunction Has eye inflammation or infection Has a history of detached retina, retinal vascular occlusion, narrow angle glaucoma, or neovascular eye disease Has ever received a facelift, browlift, or facial reconstructive surgery Has undergone mesotherapy or cosmetic treatment (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck or botulinum toxin injections within the past 6 months Has experienced trauma to the temple within the past 6 months or has residual deficiencies, deformities, or scarring Has a tendency to develop hypertrophic scarring Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein Has porphyria or untreated epilepsy Has active autoimmune disease Has current cutaneous or mucosal inflammatory or infectious processes Is on a lidocaine, anticoagulation therapy

Ages Eligible for Study
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Minimum Age: 22 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: VOLUMA® XC Treatment<br>Participants will be treated with JUVÉDERM® VOLUMA® XC injectable gel in both temples (area above the eye). Participants are eligible for touch-up treatment 30 days later. | Device: Juvéderm® VOLUMA XC<br>* Juvéderm® VOLUMA XC hyaluronic acid injectable gel<br>|
| No Intervention: Control_No Treatment<br>No treatment is administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator 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 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of 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. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported. | Month 3 | 
| Percentage of Participants Improved or Much Improved as Assessed by the Participant Using the GAIS | The participant will assess their temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported. | Month 3 |