Lip AugmentationNCT05314504
Clinical Investigation of YVOIRE Y-Solution 360 for Lip Augmentation in China
A study testing YVOIRE Y-Solution 360 in people with Lip Augmentation, run by LG Chem at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of the investigational medical device, injected into the lips. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- YVOIRE Y-Solution 360
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2022to 21 Feb 2024
- 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).
- Subjects whose volume of the overall lips corresponds to score of 0 (none/minimal), 1 (mild), 2 (moderate), or 3 (pronounced) of the 5-point LFRS as assessed by the blinded Evaluating Investigator at Visit 1 (Screening).
- Subjects who want a filler injection procedure for at least a 1-grade increase on the overall LFRS score after treatment.
- Subjects who are informed of the purpose, method, and effectiveness of the clinical investigation and who sign the written informed consent form (ICF).
- Except for surgically sterile male or female subjects, and female subjects with natural menopause (without drug intervention) for more than 2 years after last menstruation, other male or female subjects must agree to use an effective method throughout the entire clinical investigation period to prevent pregnancy
Who cannot join
- Subjects who have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area.
- Subjects who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities.
- Subjects who have undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 months before enrollment or is planning to undergo any of these procedures during the clinical investigation.
- Subjects who have received permanent facial implants or fillers (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, autologous fat) in the face or neck, or are planning to be implanted with any of these products during the clinical investigation.
- Subjects who have received non-permanent filler treatment in the lower face (below the orbital rim) or are planning to undergo during the clinical investigation, including but not limited to receiving calcium hydroxylapatite or poly-L lactic acid within 24 months before enrollment, or hyaluronic acid [HA] or collagen within 12 months before enrollment.
- Subjects who have undergone the following procedure within 6 months before enrollment or are planning to undergo during the clinical investigation: Facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face (below the orbital rim). messotherapy, face lift, stripping laser, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck.
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- Subjects who have used non-implantable lip plumping products within 10 days before enrollment anywhere in the treatment area or are planning to receive such treatment/intervention during the clinical investigation participation.
- Subjects who have used any over-the-counter or prescription, oral or topical anti-wrinkle products for the lips or around the mouth within 3 months before enrollment or are planning to use such products during the clinical investigation.
- Subjects who are on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or non-steroidal anti-inflammatory drugs (NSAIDs; e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with gingko biloba) within 10 days of undergoing investigational medical device injections.
- Subjects who have history of anaphylaxis, multiple several allergies, or allergy to lidocaine, or amide local anesthetics, HA products, or Streptococcal protein, or are planning to undergo desensitization therapy during the clinical investigation.
- Subjects with active inflammation, infection sites or unhealed wound in the mouth area.
- Subjects who have history of herpetic eruption.
- Subjects who have history of bleeding disorder based on the coagulation laboratory test results (international normalized ratio [INR], prothrombin time, and activated partial thromboplastin time [aPTT]) as per Investigator's discretion.
- Subjects with abnormal laboratory assessment and judged clinically significant per Investigator's discretion (e.g., alanine aminotransferase [ALT] ≥ 2.5×upper limit of normal [ULN], aspartate aminotransferase [AST] ≥ 2.5×ULN).
- Subjects who have porphyria.
- Subjects who have a tendency to develop hypertrophic scar or keloid.
- Subjects who have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion.
- Subjects who have malignant tumors or cancerous or precancerous lesion which could affect the clinical investigation.
- Subjects who have untreated epilepsy.
- Subjects who are ineligible for this clinical investigation as per Investigator's discretion.
- Subjects who have participated in another clinical investigation within 1 month prior to Visit 1 (Screening).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 for Lip Augmentation
To evaluate the effectiveness and safety of the investigational medical device, injected into the lips.
- Conditions
- Lip Augmentation
- Being tested
- YVOIRE Y-Solution 360
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YVOIRE Y-Solution 360Device
Cross-linked sodium hyaluronate gel for injection with lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Treatment administration to subjects Receives: Device: YVOIRE Y-Solution 360 |
| Control group | No intervention | After primary endpoint evaluation, eligible subjects will receive treatment at Week 12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall LFRS responder rate
at 12 weeks after the last injection for the test group and at Week 12 for the control group
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start11 Jan 2022
- Primary completion23 Feb 2023
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lip AugmentationStudies 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
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314504
- Sponsor's protocol ID
- LG-HACL031
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2022
- 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 Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 for Lip Augmentation
- ClinicalTrials.gov ID
- NCT05314504
- Acronym / sponsor ID
- LG-HACL031
- Conditions
- Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 6 Apr 2022 (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 the investigational medical device, injected into the lips.
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 360Treatment administration to subjects |
| Control group | No intervention | –After primary endpoint evaluation, eligible subjects will receive treatment at Week 12 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female adults 18 to 65 years of age (inclusive).
- Subjects whose volume of the overall lips corresponds to score of 0 (none/minimal), 1 (mild), 2 (moderate), or 3 (pronounced) of the 5-point LFRS as assessed by the blinded Evaluating Investigator at Visit 1 (Screening).
- Subjects who want a filler injection procedure for at least a 1-grade increase on the overall LFRS score after treatment.
- Subjects who are informed of the purpose, method, and effectiveness of the clinical investigation and who sign the written informed consent form (ICF).
- Except for surgically sterile male or female subjects, and female subjects with natural menopause (without drug intervention) for more than 2 years after last menstruation, other male or female subjects must agree to use an effective method throughout the entire clinical investigation period to prevent pregnancy
Key exclusion criteria (21 listed)
- Subjects who have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area.
- Subjects who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities.
- Subjects who have undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 months before enrollment or is planning to undergo any of these procedures during the clinical investigation.
- Subjects who have received permanent facial implants or fillers (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, autologous fat) in the face or neck, or are planning to be implanted with any of these products during the clinical investigation.
- Subjects who have received non-permanent filler treatment in the lower face (below the orbital rim) or are planning to undergo during the clinical investigation, including but not limited to receiving calcium hydroxylapatite or poly-L lactic acid within 24 months before enrollment, or hyaluronic acid [HA] or collagen within 12 months before enrollment.
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 360Cross-linked sodium hyaluronate gel for injection with lidocaine | Device | Test group |
Primary outcome
Overall LFRS responder rate
Time frame: at 12 weeks
at 12 weeks after the last injection for the test group and at Week 12 for the control group
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
Related trials for Lip Augmentation
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Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 360 in people with Lip Augmentation, 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 5 inclusion and 21 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 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?
Overall LFRS responder rate (time frame: at 12 weeks). 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.