Midface Volume DeficitNCT04784299
To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume
A study testing YVOIRE volume plus and Restylane Lyft with Lidocaine in people with Midface Volume Deficit, run by LG Chem at 1 site in Germany.
Trial summary
A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Midface Volume Deficit
- What is being tested?
- YVOIRE volume plus and Restylane Lyft with Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- 22 Mar 2021to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female aged between 21 to 75 years (inclusive)
- 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
- Desire cheek augmentation to correct volume deficit in the midface.
- Agree to use contraception
- Sign Informed Consent Form
Who cannot join
- have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
- have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
- have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
- have history of bleeding disorder
- have a tendency to develop hypertrophic scarring or keloid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume
A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
Read the detailed description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.
- Conditions
- Midface Volume Deficit
- Being tested
- YVOIRE volume plus, Restylane Lyft with Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YVOIRE volume plusDevice
Hyaluronic acid dermal filler
Restylane Lyft with LidocaineDevice
Hyaluronic acid dermal filler
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE volume plus | Experimental | Hyaluronic acid dermal filler Receives: Device: YVOIRE volume plus |
| Restylane Lyft with Lidocaine | Active comparator | Hyaluronic acid dermal filler Receives: Device: Restylane Lyft with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine
To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment
Measured: 24 weeks from baseline
Responder rate of YVOIRE volume plus
To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment
Measured: 24 weeks from baseline
Secondary outcomes (5)
Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)
To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS
Measured: 4, 8, 12, 52 weeks from baseline
Responder rate of YVOIRE volume plus
To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment
Measured: 4, 8, 12, 52 weeks from baseline
Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)
- compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS
Measured: 4, 8, 12, 24, 52 weeks from baseline
The mean scores of the GAIS
To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS)
Measured: 4, 8, 12, 24, 52 weeks from baseline
Mean change in mid-face volume
To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement
Measured: 24 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start22 Mar 2021
- Primary completion11 Apr 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midface Volume DeficitStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Investigator, Principal investigator, LG Chem Investigational site 01
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784299
- Sponsor's protocol ID
- LG-HACL029
- Status last verified
- Dec 2024
- First submitted
- 3 Mar 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume
- ClinicalTrials.gov ID
- NCT04784299
- Acronym / sponsor ID
- LG-HACL029
- Conditions
- Midface Volume Deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
Detailed description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YVOIRE volume plus | Experimental | Device: YVOIRE volume plusHyaluronic acid dermal filler |
| Restylane Lyft with Lidocaine | Active comparator | Device: Restylane Lyft with LidocaineHyaluronic acid dermal filler |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female aged between 21 to 75 years (inclusive)
- 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
- Desire cheek augmentation to correct volume deficit in the midface.
- Agree to use contraception
- Sign Informed Consent Form
Key exclusion criteria (6 listed)
- have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
- have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
- have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
- have history of bleeding disorder
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 |
|---|---|---|
| YVOIRE volume plusHyaluronic acid dermal filler | Device | YVOIRE volume plus |
| Restylane Lyft with LidocaineHyaluronic acid dermal filler | Device | Restylane Lyft with Lidocaine |
Primary outcome
Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine
Time frame: 24 weeks from baseline
To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment
Responder rate of YVOIRE volume plus
Time frame: 24 weeks from baseline
To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment
5 secondary outcomes
Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)
Time frame: 4, 8, 12, 52 weeks from baseline
Responder rate of YVOIRE volume plus
Time frame: 4, 8, 12, 52 weeks from baseline
Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)
Time frame: 4, 8, 12, 24, 52 weeks from baseline
The mean scores of the GAIS
Time frame: 4, 8, 12, 24, 52 weeks from baseline
Mean change in mid-face volume
Time frame: 24 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- 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.
Investigator principal investigator
LG Chem Investigational site 01
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YVOIRE volume plus and Restylane Lyft with Lidocaine in people with Midface Volume Deficit, run by LG Chem at 1 site in Germany.
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 5 inclusion and 6 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 19 Dec 2024. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine (time frame: 24 weeks from baseline). 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 19 Dec 2024.