Correction of Nasolabial FoldsNCT02661737
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s
An observational study of Correction of Nasolabial Folds, run by LG Life Sciences.
Trial summary
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Correction of Nasolabial Folds
- What is being tested?
- YVOIRE volume s
- Type of treatment
- Medical device
- How many people
- 503 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Subject who receive hyaluronic acid filler into the nasolabial folds
Who may be able to join
- Subjects whose age is over 18 years old and under 65 years old
- Subjects whose WSRS grade is equal or greater than 2
- Subjects must be willing and able to provide written informed consent form
- Subjects who are scheduled to be treated with YVOIRE volumes for facial tissue augmentation to correct the nasolabial folds
Who cannot join
- Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE volume s
- Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds
- Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening
- Subjects who have received face lifting or plastic surgery on face within 9 months before screening
- Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening
- Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites
Show all 9Show fewer
- Subjects who tend to have hypertrophic scars
- Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders.
- Women in pregnancy or lactation
About this study
Official title: A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of Modified Sodium Hyaluronate Gel (YVOIRE Volume s) Injected for Correction of Nasolabial Folds
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.
- Conditions
- Correction of Nasolabial Folds
- Being tested
- YVOIRE volume s
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YVOIRE volume sDevice
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE volume s | Treatment with YVOIRE volume s Receives: Device: YVOIRE volume s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Device-related Adverse Events
Measured: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionApr 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Correction of Nasolabial FoldsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661737
- Sponsor's protocol ID
- LG-HAOS005
- Status last verified
- Nov 2018
- First submitted
- 19 Jan 2016
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of Modified Sodium Hyaluronate Gel (YVOIRE Volume s) Injected for Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT02661737
- Acronym / sponsor ID
- LG-HAOS005
- Conditions
- Correction of Nasolabial Folds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Posted 19 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YVOIRE volume s | – | Device: YVOIRE volume sTreatment with YVOIRE volume s |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject who receive hyaluronic acid filler into the nasolabial folds
Key inclusion criteria (4 listed)
- Subjects whose age is over 18 years old and under 65 years old
- Subjects whose WSRS grade is equal or greater than 2
- Subjects must be willing and able to provide written informed consent form
- Subjects who are scheduled to be treated with YVOIRE volumes for facial tissue augmentation to correct the nasolabial folds
Key exclusion criteria (9 listed)
- Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE volume s
- Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds
- Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening
- Subjects who have received face lifting or plastic surgery on face within 9 months before screening
- Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening
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 s | Device | YVOIRE volume s |
Primary outcome
Incidence of Device-related Adverse Events
Time frame: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Correction of Nasolabial Folds, run by LG Life Sciences.
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 9 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Device-related Adverse Events (time frame: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years). 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 Mar 2019.