Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

NCT05622851 | Completed Results FDA Device

• 1 other identifier: GLI.04.US.SL.015
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Volume Deficiency of the Midface

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Evaluate Volume Change in the Treated Areas Using 3D Imaging

  4 weeks

• Evaluate Volume Change in the Treated Areas Using 3D Imaging

  6 months

• Evaluate Volume Change in the Treated Areas Using 3D Imaging

  9 months

• Evaluate Volume Change in the Treated Areas Using 3D Imaging

  12 months

• Evaluate Subject Satisfaction Using Self-assessment Questionnaire

  4 weeks

Study Arms (2)

Restylane Contour

ACTIVE COMPARATOR

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

Juvederm Voluma

ACTIVE COMPARATOR

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

Interventions

Restylane Contour DEVICE

Hyaluronic Acid dermal filler

Restylane Contour

Juvederm Voluma DEVICE

Hyaluronic Acid dermal filler

Juvederm Voluma

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

The Aesthetic Clinique

Santa Rosa Beach, Florida, 32459, United States

Location

Limitations and Caveats

The sample size was relatively small, which may limit the generalizability of the findings. However, the split- face design enhances the power of the side-by-side product comparisons.

Results Point of Contact

• Title: Thu Q. Nguyen, PhD
• Organization: Galderma

thu.nguyen@galderma.com

8179615495

Study Officials

• Steven F Weiner, MD

  The Aesthetic Clinique

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects are blinded to treatment assignment to each side of their faces.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, split-face, subject-blinded, comparative

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 21, 2022
• Study Start: July 12, 2022
• Primary Completion: September 25, 2023
• Study Completion: December 6, 2023
• Last Updated: May 4, 2026
• Results First Posted: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)