Wrinkles in the Nasolabial FoldsNCT04855188
Effectiveness and Safety of YVOIRE Y-Solution 540
A study testing YVOIRE Y-Solution 540 and YVOIRE volume plus in people with Wrinkles in the Nasolabial Folds, run by LG Chem at 1 site in China.
Trial summary
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles in the Nasolabial Folds
- What is being tested?
- YVOIRE Y-Solution 540 and YVOIRE volume plus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 14 Jul 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
- 3 (moderate) or 4 (severe) on the 5-graded WSRS
- who sign the written informed consent form
Who cannot join
- who have received permanent facial implants
- who have received semi-permanent fillers
- who have undergone temporary dermal filler treatment within 12 months
- who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
- who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
About this study
Official title: A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 Versus YVOIRE Volume Plus in Nasolabial Folds Injection
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection
- Conditions
- Wrinkles in the Nasolabial Folds
- Being tested
- YVOIRE Y-Solution 540, YVOIRE volume plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YVOIRE Y-Solution 540Device
Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.
YVOIRE volume plusDevice
Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE Y-Solution 540 | Experimental | Not described Receives: Device: YVOIRE Y-Solution 540 |
| YVOIRE volume plus | Active comparator | Not described Receives: Device: YVOIRE volume plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS responder rate
the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score
Measured: 24 weeks after the last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Jul 2021
- Primary completion29 Sep 2022
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles in the 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 394 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
- NCT04855188
- Sponsor's protocol ID
- LG-HACL027
- Status last verified
- Dec 2024
- First submitted
- 19 Apr 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 Versus YVOIRE Volume Plus in Nasolabial Folds Injection
- ClinicalTrials.gov ID
- NCT04855188
- Acronym / sponsor ID
- LG-HACL027
- Conditions
- Wrinkles in the Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 22 Apr 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.
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection
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 540 | Experimental | Device: YVOIRE Y-Solution 540 |
| YVOIRE volume plus | Active comparator | Device: YVOIRE volume plus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 3 (moderate) or 4 (severe) on the 5-graded WSRS
- who sign the written informed consent form
Key exclusion criteria (5 listed)
- who have received permanent facial implants
- who have received semi-permanent fillers
- who have undergone temporary dermal filler treatment within 12 months
- who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
- who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein
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 540Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment. | Device | YVOIRE Y-Solution 540 |
| YVOIRE volume plusInjection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment. | Device | YVOIRE volume plus |
Primary outcome
WSRS responder rate
Time frame: 24 weeks after the last injection
the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score
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.
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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 540 and YVOIRE volume plus in people with Wrinkles in the Nasolabial Folds, 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 2 inclusion and 5 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?
WSRS responder rate (time frame: 24 weeks after the last injection). 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.