Volume Defects in the Mid-faceNCT04437745
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
A study testing YVOIRE Y-Solution 720 in people with Volume Defects in the Mid-face, run by LG Chem at 1 site in China.
Trial summary
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Volume Defects in the Mid-face
- What is being tested?
- YVOIRE Y-Solution 720
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2020to 8 Nov 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults 18 to 65 years of age (inclusive)
- 3 (moderate) or 4 (severe) on MFVDA-SRS
- sign the written informed consent form
Who cannot join
- have streptococcal disease or bleeding disorder
- have an active or infective skin disease, scars, or tumor on mid-face
- have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
- have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
- have a medical history of hypertrophic cicatrix or keloid
- have radiation therapy experience on mid-face
- have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
- Conditions
- Volume Defects in the Mid-face
- Being tested
- YVOIRE Y-Solution 720
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YVOIRE Y-Solution 720Device
Hyaluronic acid dermal filler
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE Y-Solution 720 | Experimental | Hyaluronic acid dermal filler Receives: Device: YVOIRE Y-Solution 720 |
| Control | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate
the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.)
Measured: 26 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 posted18 Jun 2020
- Study start25 Nov 2020
- Primary completion13 Dec 2022
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume Defects in the Mid-faceStudies 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
- Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojun Wang, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437745
- Sponsor's protocol ID
- LG-HACL022
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
- ClinicalTrials.gov ID
- NCT04437745
- Acronym / sponsor ID
- LG-HACL022
- Conditions
- Volume Defects in the Mid-face
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 18 Jun 2020 (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.
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YVOIRE Y-Solution 720 | Experimental | Device: YVOIRE Y-Solution 720Hyaluronic acid dermal filler |
| Control | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adults 18 to 65 years of age (inclusive)
- 3 (moderate) or 4 (severe) on MFVDA-SRS
- sign the written informed consent form
Key exclusion criteria (8 listed)
- have streptococcal disease or bleeding disorder
- have an active or infective skin disease, scars, or tumor on mid-face
- have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
- have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
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 Y-Solution 720Hyaluronic acid dermal filler | Device | YVOIRE Y-Solution 720 |
Primary outcome
Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate
Time frame: 26 weeks from baseline
the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.)
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 9 Feb 2024.
Related trials for Volume Defects in the Mid-face
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
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.
Xiaojun Wang principal investigator
Peking Union Medical College Hospital
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 Y-Solution 720 in people with Volume Defects in the Mid-face, run by LG Chem at 1 site in China.
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 8 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 9 Feb 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 China. 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?
Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate (time frame: 26 weeks from baseline). 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 9 Feb 2024.