A Study Evaluating JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants Over 22 Years Old

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 Juvederm Voluma XC injectable gel in adult participants seeking correction of temple hollowing

Official Title
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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

Conditions
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Temple Hollowing

Intervention / Treatment
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* Device: JUVÉDERM VOLUMA® XC
* Other: No-treatment control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in general good health Participants seeking improvement of temple hollowing Exclusion Criteria: Temple hollowing due to trauma, congenital malformations, or lipodystrophy Temporomandibular joint dysfunction or any other jaw issues Recurrent temporal headaches such as temporal tendinitis migraine Active autoimmune disease History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein 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 24 months before enrollment Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment Botulinum toxin treatment above the subnasale within 6 months before enrollment Females who are pregnant, nursing, or planning a pregnancy

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: JUVÉDERM VOLUMA® XC Treatment<br>Participants received JUVÉDERM VOLUMA® XC injectable gel treatment in both temples followed by an optional touch-up treatment 30 days later. | Device: JUVÉDERM VOLUMA® XC<br>* JUVÉDERM VOLUMA® XC injectable gel<br>|
| Other: No-treatment control<br>Participants received no treatment for 3 months and then received an optional delayed treatment with JUVÉDERM VOLUMA® XC and an optional touch-up treatment 30 days later. | Other: No-treatment control<br>* Participants received no treatment for 3 months and then received an optional delayed treatment with JUVÉDERM VOLUMA® XC and an optional touch-up treatment 30 days later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 5-point ATHS 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 | 
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study device. | From Day 1 to Day 395 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Improved  or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the temple area as assessed by the Evaluating Investigator | The Evaluating Investigator will assess the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. | Month 3 | 
| Percentage of participants Improved  or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the temple area as assessed by the participants | Participant will assess temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. | Month 3 | 
| Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 3 | The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. | Change from Baseline to Month 3 | 
| Change from baseline to Month 3 on participants responses on FACE-Q Satisfaction with Temples questionnaire | The participants responded to each item on the FACE-Q Satisfaction with Temple questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. | Change from Baseline to Month 3 |