Skip to main content
OpenTrials
Completed

NCT Number: NCT05622851

Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Volume Deficiency of the Midface

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Aesthetic Clinique

Santa Rosa Beach, Florida, 32459, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Restylane Contour

Device

Hyaluronic Acid dermal filler

Juvederm Voluma

Device

Hyaluronic Acid dermal filler

Primary outcomes

  1. Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound

    Time frame: Immediately post-treatment

    Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.

  2. Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound

    Time frame: 12 months

    Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.

Secondary outcomes

  1. Evaluate Volume Change in the Treated Areas Using 3D Imaging

    Time frame: 4 weeks

    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.

  2. Evaluate Volume Change in the Treated Areas Using 3D Imaging

    Time frame: 6 months

    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.

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

    Time frame: 9 months

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

    Time frame: 12 months

    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.

  5. Evaluate Subject Satisfaction Using Self-assessment Questionnaire

    Time frame: 4 weeks

    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. Evaluate Subject Satisfaction Using Self-assessment Questionnaire

    Time frame: 6 months

    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).

  7. Evaluate Subject Satisfaction Using Self-assessment Questionnaire

    Time frame: 9 months

    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).

  8. Evaluate Subject Satisfaction Using Self-assessment Questionnaire

    Time frame: 12 months

    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).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Acronym: RES

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2022
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.