JUVÉDERM® VOLITE™ XC for Cheek Skin Smoothness

Study Overview
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Brief Summary
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This is a pivotal study to collect safety and effectiveness data on JUVÉDERM VOLITE™ XC for improvement in skin smoothness of the cheeks in order to support FDA product approval.

Official Title
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Protocol Title: A Randomized, Multicenter, Evaluator-blind, Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLITE™ XC Injectable Gel for the Improvement in Cheek Skin Smoothness

Conditions
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Skin Smoothness of the Cheeks

Intervention / Treatment
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* Device: JUVÉDERM VOLITE™ XC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to follow study instructions and likely to complete all required visits; Written informed consent and data privacy consent have been obtained Exclusion Criteria: Has undergone tissue augmentation with dermal fillers including hyaluronic acid (HA), calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the fact within 12 months before screening or is planning to undergo any such treatment during the study; Has received any crosslinked HA filler in any anatomic area within 12 months of screening; Has undergone treatment with botulinum toxin in the cheek area (including crow's feet) within 6 months of screening or is planning to undergo such treatment during the study; Has ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafuoroethylene) anywhere in the face or is planning to be implanted with any of these products at any time during the study; Has facial tattoos, piercings, pigmentation, hair (ie, beard, mustache), or past trauma that would interfere with the visualization of the face for the effectiveness assessments; Has undergone a dental procedure within 6 weeks before treatment or plans to undergo a dental procedure (other than prophylasix or dental fillings) during the course of the study; Has tendency to develop hypertrophic scarring; Has a history of allergy to lidocaine, HA products, and/or to gram-positive bacterial proteins as HA is produced by Streptococcus-type bacteria, or is planning to undergo desensitization therapy during the term of the study; Has a history of anaphylactic shock; Has current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face (injection may be delayed to allow subjects with a history of recurrent oral herpes to take prophylactic antiviral/herpes medication for 2 days); Is on an ongoing regimen of anticoagulation therapy (eg, warfarin) or is known to have a coagulation disorder; Is on an ongoing regimen of medications (eg, aspirin, ibuprofen) or other substances (eg, herbal supplements with garlic, ginkgo biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection (study device injection may be delayed as necessary to accommodate this 10-day washout period); Has active autoimmune disease; Has received any investigational product within 30 days before enrollment or is planning to participate in another investigation during the course of this study; - Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle products on the face within 30 days before enrollment or is planning to begin using such products during the study (subjects 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); Females who are pregnant, nursing, or planning a pregnancy during the study; Is an employee (or a relative of an employee) of the principal investigator (PI)/evaluating investigator (EI)/treating investigator(TI)/site, Allergan, or representative of Allergan' Has a condition or is in a situation which, in the TI's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

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® VOLITE™<br>Participants received an initial treatment of JUVÉDERM® VOLITE™ XC injectable gel, intradermally up to 4 milliliters (mL) on Day 1 followed by an optional touch-up treatment up to 2 mL on Day 30, if applicable. Participants were eligible to receive repeat treatment up to 4 mL at Month 6, if applicable. | Device: JUVÉDERM VOLITE™ XC<br>* Intradermal, needle in multiple microdepot injections across both cheeks.<br>|
| Experimental: Control Group: No Treatment Then Optional JUVÉDERM® VOLITE™<br>Participants received no treatment for up to 30 days and then received an optional JUVÉDERM® VOLITE™ XC injectable gel initial treatment intradermally up to 4 mLs and an optional touch-up treatment up to 2 mL 30 days later, if applicable. | Device: JUVÉDERM VOLITE™ XC<br>* Intradermal, needle in multiple microdepot injections across both cheeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 1-point Improvement (Decrease) From Baseline on the Allergan Cheek Smoothness Scale (ACSS) on Both Cheeks at Month 1 | The ACSS is a validated 5-point ordinal scale developed by Allergan to grade the severity of skin smoothness on the cheeks. The score ranges from 0 (smooth visual skin texture) to 4 (extremely coarse visual skin texture, crosshatched deep creases, extreme elastosis. Responders are participants with at least 1-point improvement (decrease) from baseline on the ACSS on both cheeks based on evaluating investigator (EI) assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period. The multiple imputation method for the missing data imputation was used for analysis. | Baseline to Month 1 | 
| Number of Participants Who Experience One or More Treatment Emergent Adverse Event (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical device which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study device. An AE was considered a treatment emergent adverse event (TEAE) if the AE began or worsened (increased in severity or became serious) after first administration of VOLITE for the treatment group and after the date of randomization for the control group. | From first dose of study treatment until 30 days following last dose of study treatment (up to approximately 12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Face-Q Satisfaction With Skin Questionnaire at Month 1 | The participant assessed satisfaction using the 12 items on the FACE-Q: Satisfaction with Skin questionnaire measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied. The responses to the 12 items were summed and converted to a scale score that ranges from 0 (worst) to 100 (best). Higher score indicates more satisfaction. A positive change from baseline indicates improvement. | Baseline and Month 1 | 
| Percentage of Participants With at Least 1-Point Improvement (Decreased) From Baseline on Both Cheeks in the Allergan Fine Lines Scale (AFLS) Response at Month 1 | The AFLS is a validated 5-point ordinal scale developed by Allergan to grade the severity of fine lines on the cheeks. The score ranges from 0 (no fine lines) to 4 (diffuse superficial lines, crosshatching). Responders are participants with at least 1-point improvement (decrease) from baseline on the AFLS on both cheeks based on observed data of EI assessment. Baseline is the last non-missing EI assessment on or before the latter of randomization date or first study treatment date in the control period. | Baseline to Month 1 |