Healthy ConditionNCT04738019
A Multicenter, Prospective Observational Study to Evaluate the Incidence of Delayed-onset Nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 Injected Into the Facial Skin Layer.
An observational study of Healthy Condition, run by LG Chem at 1 site in South Korea.
Trial summary
This is an observational study to evaluate the incidence of delayed-onset nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 injected into the facial skin layer. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Condition
- What is being tested?
- Medical examination or treatment.
- Type of treatment
- Injection or infusion
- How many people
- 1,022 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jun 2020to 28 Feb 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any healthy male and female whose filler injection on facial area is already planned for volume enhancement and anti-wrinkle treatment.
Who may be able to join
- Planned for YVOIRE Y-Solution 360 or 540 or 720 filler injection in facial area (except middle of the forehead, lips) for the volume enhancement or anti-wrinkle treatment.
- Male and female of 19 years or above age.
- Informed consent to participate in the study.
- Able to participate throughout the study period.
Who cannot join
- Prohibited in the Product Label.
- Have active or infectious skin disease in injection area.
- Autoimmune disease or HIV infected patient.
- Received immunosuppressive therapy within 2 weeks.
- Previously experienced Delayed-onset nodule after filler injection in facial area.
- Previously experienced Hypertrophic scar or Keloid.
- Have participated in an interventional clinical investigation within 30 days or plan to participate one during the study period.
- Ineligible for this clinical investigation as per Investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study to evaluate the incidence of delayed-onset nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 injected into the facial skin layer.
- Conditions
- Healthy Condition
- Being tested
- Medical examination or treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical examination or treatment.Diagnostic test
Medical examination or treatment when delayed on-set nodule or other side effects occur due to Y-Solution filler injection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed-onset nodule.
Incidence of delayed-onset nodule in the facial area Y-Solution 360 or 540 or 720 is injected.
Measured: 1 year.
Other adverse events.
Other adverse events occur in the facial area Y-Solution 360 or 540 or 720 is injected.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start18 Jun 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ConditionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,022 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738019
- Sponsor's protocol ID
- LG-HAOS007
- Status last verified
- Jan 2023
- First submitted
- 1 Feb 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incidence rate of delayed-onset nodule or other side effects when YVOIRE Y-Solution 360 or 540 or 720 are used.
Publications
Park SJ, Yoo KH. One-Year Safety Evaluation of New Hyaluronic Acid Fillers (YYS Series): A Prospective, Multicenter, Observational Study. Dermatol Surg. 2024 Aug 1;50(8):731-738. doi: 10.1097/DSS.0000000000004190. Epub 2024 May 2.
PubMed 38595129
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Observational Study to Evaluate the Incidence of Delayed-onset Nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 Injected Into the Facial Skin Layer.
- ClinicalTrials.gov ID
- NCT04738019
- Acronym / sponsor ID
- LG-HAOS007
- Conditions
- Healthy Condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,022 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 4 Feb 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.
This is an observational study to evaluate the incidence of delayed-onset nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 injected into the facial skin layer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any healthy male and female whose filler injection on facial area is already planned for volume enhancement and anti-wrinkle treatment.
Key inclusion criteria (4 listed)
- Planned for YVOIRE Y-Solution 360 or 540 or 720 filler injection in facial area (except middle of the forehead, lips) for the volume enhancement or anti-wrinkle treatment.
- Male and female of 19 years or above age.
- Informed consent to participate in the study.
- Able to participate throughout the study period.
Key exclusion criteria (8 listed)
- Prohibited in the Product Label.
- Have active or infectious skin disease in injection area.
- Autoimmune disease or HIV infected patient.
- Received immunosuppressive therapy within 2 weeks.
- Previously experienced Delayed-onset nodule after filler injection in facial area.
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 |
|---|---|---|
| Medical examination or treatment.Medical examination or treatment when delayed on-set nodule or other side effects occur due to Y-Solution filler injection. | Diagnostic test | – |
Primary outcome
Delayed-onset nodule.
Time frame: 1 year.
Incidence of delayed-onset nodule in the facial area Y-Solution 360 or 540 or 720 is injected.
Other adverse events.
Time frame: 1 year.
Other adverse events occur in the facial area Y-Solution 360 or 540 or 720 is injected.
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 Jan 2023.
- Derived from this study: PubMed 38595129Park SJ, Yoo KH. One-Year Safety Evaluation of New Hyaluronic Acid Fillers (YYS Series): A Prospective, Multicenter, Observational Study. Dermatol Surg. 2024 Aug 1;50(8):731-738. doi: 10.1097/DSS.0000000000004190. Epub 2024 May 2.
- Individual participant dataSharing planned: Yes. Incidence rate of delayed-onset nodule or other side effects when YVOIRE Y-Solution 360 or 540 or 720 are used.
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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?
An observational study of Healthy Condition, run by LG Chem at 1 site in South Korea.
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 4 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 12 Jan 2023. 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 South Korea. 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?
Delayed-onset nodule. (time frame: 1 year.). 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?
On the ClinicalTrials.gov record for NCT04738019, which also lists 1 linked publication.
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 Jan 2023; AzTrials last refreshed its copy on 31 Oct 2026.