Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers (RES)

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

To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound

Study Overview

• Status: Completed
• Conditions: Volume Deficiency of the Midface
• Intervention / Treatment: Device: Restylane Contour; Device: Juvederm Voluma

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Santa Rosa Beach, Florida, United States, 32459
      • The Aesthetic Clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Restylane Contour; 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; Hyaluronic Acid dermal filler
Active Comparator: Juvederm Voluma; 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; Hyaluronic Acid dermal filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound	Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.	Immediately post-treatment
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound	Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	6 months
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.	9 months
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.	12 months
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
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).	6 months
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).	9 months
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).	12 months

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Steven F Weiner, MD, The Aesthetic Clinique

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): September 25, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GLI.04.US.SL.015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No