A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.

Official Title
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A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

Conditions
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Age-related Volume Deficit in the Mid-face

Intervention / Treatment
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* Device: JUVÉDERM VOLUMA® XC injectable gel with cannula
* Device: JUVÉDERM VOLUMA® XC injectable gel with needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS); Exclusion criteria: Has any facial procedures or trauma that may interfere with the study procedures and results; Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study; Has active autoimmune disease; Has current cutaneous or mucosal inflammatory or infectious processes.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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 Injectable Gel with Cannula<br>Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula. | Device: JUVÉDERM VOLUMA® XC injectable gel with cannula<br>* Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.<br>|
| Other: JUVÉDERM VOLUMA® XC Injectable Gel with Needle<br>Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle. | Device: JUVÉDERM VOLUMA® XC injectable gel with needle<br>* Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score | The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement. | Baseline (Screening) to Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score | The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported. | Baseline (Screening) to Month 1 | 
| Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score | The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek. | Baseline (Screening) to Month 1 | 
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and 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. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date. | Up to 3 months |