Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

Study Overview
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Brief Summary
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To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound

Detailed Description
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This is a randomized, split-face, subject-blinded, comparative study to assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound. This study is designed to enroll and randomize approximately 15 subjects in a 1:1 ratio of treatment to Restylane Contour or Juvederm Voluma. All subjects are to have midface volume loss and contour deficiency. Eligible subjects are randomized to receive treatment were injected by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator and subject. At the 4-week visit, after all study procedures for the visit are completed, treated subjects have the option of receiving a touch-up treatment to achieve optimal aesthetic improvement. At the 6-month, 9-month, and 12-month visits, similar study procedures are performed.

Official Title
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A Randomized, Split-face Clinical Study on Comparative Ultrasound Analysis of Two Hyaluronic Acid Fillers for Midface Correction

Conditions
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Volume Deficiency of the Midface

Intervention / Treatment
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* Device: Restylane Contour
* Device: Juvederm Voluma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with midface volume loss and contour deficiency Ability of giving consent for participation in the study Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments Exclusion Criteria: History of allergy or hypersensitivity to lidocaine and/or injectable hyaluronic acid Previous permanent or semi-permanent implant in proposed treatment area Previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit History of other facial treatment/procedure at the study area (midface) in the previous 6 months that would potentially interfere with study injections (e.g., facial surgery, oral surgery, resurfacing, mesotherapy, lipolytic injections, botulinum toxin injections)

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Randomized, split-face, subject-blinded, comparative
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restylane Contour<br>Form: transparent gel of Hyaluronic Acid with the addition of lidocaine hydrochloride. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. | Device: Restylane Contour<br>* Hyaluronic Acid dermal filler<br>|
| Active Comparator: Juvederm Voluma<br>Form: sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of Hyaluronic Acid crosslinked with BDDE, formulated with lidocaine. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. | Device: Juvederm Voluma<br>* Hyaluronic Acid dermal filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess and compare tissue aggregation and visualization of Hyaluronic Acid fillers using ultrasound | Change in filler properties within the skin tissues. Filler properties include size, shape, and aggregation at different facial expressions. | Immediately post-treatment, 4 weeks, 6 months, 9 months, and 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate subject satisfaction using self-assessment questionnaire | Percentage of response at 4 weeks, 6 months, 9 months, and 12 months, where subjects are asked about their satisfaction with treatment outcome on the midface. Scale consists of 3 preference questions (with no difference option) and 6 satisfaction questions (with strongly agree, agree, neutral, disagree, and strongly disagree). | 4 weeks, 6 months, 9 months, and 12 months after baseline | 
| Evaluate volume change in the treated areas using 3D imaging | Summary of total volume change in the midface measured by digital 3D photography at each visit. Total volume change corresponds to net volume change from baseline in the treated area. | 4 weeks, 6 months, 9 months, and 12 months after baseline |