Volume Deficiency of the MidfaceRESNCT05622851
Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers
A study testing Restylane Contour and Juvederm Voluma in people with Volume Deficiency of the Midface, run by Galderma R&D at 1 site in United States.
Trial summary
To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Volume Deficiency of the Midface
- What is being tested?
- Restylane Contour and Juvederm Voluma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Aesthetic Clinique
Santa Rosa Beach, Florida, 32459
About this study
Official title: 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
Read the 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.
- Conditions
- Volume Deficiency of the Midface
- Being tested
- Restylane Contour, Juvederm Voluma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane ContourDevice
Hyaluronic Acid dermal filler
Juvederm VolumaDevice
Hyaluronic Acid dermal filler
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Juvederm Voluma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start12 Jul 2022
- Primary completion25 Sep 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Volume Deficiency of the MidfaceStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, split-face, subject-blinded, comparative
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven F Weiner, MD, Principal investigator, The Aesthetic Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622851
- Sponsor's protocol ID
- GLI.04.US.SL.015
- Acronym
- RES
- Status last verified
- May 2026
- First submitted
- 7 Nov 2022
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Split-face Clinical Study on Comparative Ultrasound Analysis of Two Hyaluronic Acid Fillers for Midface Correction
- ClinicalTrials.gov ID
- NCT05622851
- Acronym / sponsor ID
- RES / GLI.04.US.SL.015
- Conditions
- Volume Deficiency of the Midface
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Posted 4 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, split-face, subject-blinded, comparative
| Arm | Type | Receives |
|---|---|---|
| Restylane Contour | Active comparator | Device: Restylane ContourForm: 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. |
| Juvederm Voluma | Active comparator | Device: Juvederm VolumaForm: 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. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restylane ContourHyaluronic Acid dermal filler | Device | Restylane Contour |
| Juvederm VolumaHyaluronic Acid dermal filler | Device | Juvederm Voluma |
Primary outcome
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.
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.
8 secondary outcomes
Evaluate Volume Change in the Treated Areas Using 3D Imaging
Time frame: 4 weeks
Evaluate Volume Change in the Treated Areas Using 3D Imaging
Time frame: 6 months
Evaluate Volume Change in the Treated Areas Using 3D Imaging
Time frame: 9 months
Evaluate Volume Change in the Treated Areas Using 3D Imaging
Time frame: 12 months
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
Time frame: 4 weeks
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
Time frame: 6 months
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
Time frame: 9 months
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven F Weiner, MD principal investigator
The Aesthetic Clinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Contour and Juvederm Voluma in people with Volume Deficiency of the Midface, run by Galderma R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound (time frame: Immediately post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.