Jaw Volume DeficitNCT04886544
Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
A study testing YVOIRE Y-Solution 720 in people with Jaw Volume Deficit, run by LG Chem at 3 sites in 2 countries.
Trial summary
A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw Volume Deficit
- 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
- 72 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Jun 2021to 9 Jan 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults 18 - 75 years of age (inclusive)
- 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS)
- want a filler injection procedure for the replacement of volume loss in the jawlines
Who cannot join
- have an active or infective skin disease
- have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- have a tattoo or excessive facial hair in the evaluation area
- have received permanent facial implants
- have undergone semi-permanent filler within 24 months
- have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months
Show all 14Show fewer
- have streptococcal disease
- have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid
- have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products
- have history of bleeding disorder
- have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion
- have known malignant tumors or cancerous or precancerous lesion
- positive pregnancy test indicating pregnancy
- active COVID-19 infection and suspected COVID-19 infection within the past 14 days
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Austria2 sites
LG Chem investigational site 01
Vienna
LG Chem investigational site 02
Vienna
About this study
Official title: A Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
Read the detailed description
This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.
- Conditions
- Jaw Volume Deficit
- 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 |
|---|---|---|
| Test group | Experimental | Hyaluronic acid dermal filler at Week 0 Receives: Device: YVOIRE Y-Solution 720 |
| Control group | No intervention | Remain untreated until Week 26 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection for the test group and at Week 26 for the control group, i.e., the proportion of subjects with ≥1 grade improvement on the JCRS score (both jawlines) rated by independent blinded Evaluators at the site (Evaluating Investigator) at Visit 5, compared to that at Baseline (Visit 1).
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 posted14 May 2021
- Study start25 Jun 2021
- Primary completion11 May 2022
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw 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
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, LG Chem Investigational site 01
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886544
- Sponsor's protocol ID
- LG-HACL025
- Status last verified
- May 2023
- First submitted
- 10 May 2021
- Last updated
- 12 May 2023
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
- ClinicalTrials.gov ID
- NCT04886544
- Acronym / sponsor ID
- LG-HACL025
- Conditions
- Jaw Volume Deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 14 May 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 Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
Detailed description
This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: YVOIRE Y-Solution 720Hyaluronic acid dermal filler at Week 0 |
| Control group | No intervention | –Remain untreated until Week 26 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adults 18 - 75 years of age (inclusive)
- 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS)
- want a filler injection procedure for the replacement of volume loss in the jawlines
Key exclusion criteria (14 listed)
- have an active or infective skin disease
- have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- have a tattoo or excessive facial hair in the evaluation area
- have received permanent facial implants
- have undergone semi-permanent filler within 24 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 | Test group |
Primary outcome
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection
Time frame: 26 weeks from baseline
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection for the test group and at Week 26 for the control group, i.e., the proportion of subjects with ≥1 grade improvement on the JCRS score (both jawlines) rated by independent blinded Evaluators at the site (Evaluating Investigator) at Visit 5, compared to that at Baseline (Visit 1).
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 12 May 2023.
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.
Principal Investigator principal investigator
LG Chem Investigational site 01
3 sites in 2 countries: 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 Jaw Volume Deficit, run by LG Chem at 3 sites in 2 countries.
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 14 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 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Poland. 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?
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection (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 12 May 2023.