Correction of Nasolabial FoldsPhase 4NCT05106751
A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds
A Phase 4 study testing Hyaluronic acid dermal filler in people with Correction of Nasolabial Folds, run by LG Chem at 1 site in Germany.
Trial summary
A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Correction of Nasolabial Folds
- What is being tested?
- Hyaluronic acid dermal filler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- 21 Oct 2021to 3 Apr 2023
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 21 years or above age.
- 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale).
- Agree to use proper contraception as guided in the protocol.
- Signed for Informed Consent.
Who cannot join
- have received permanent facial implants anywhere in the face or neck or planning during the investigation.
- have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks
- have undergone semi-permanent filler in lower face
- have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months
- Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face
- Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months
- have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days
Trial locations and contacts
1 site in 1 country.
About this study
A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.
Read the detailed description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.
- Conditions
- Correction of Nasolabial Folds
- Being tested
- Hyaluronic acid dermal filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid dermal fillerDevice
Hyaluronic acid dermal filler used for facial volume or wrinkle correction
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE Classic plus | Experimental | Not described Receives: Device: Hyaluronic acid dermal filler |
| Restylane Lidocaine | Active comparator | Not described Receives: Device: Hyaluronic acid dermal filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.
To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme).
Measured: 24 weeks from baseline
Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.
To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated.
Measured: 24 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 posted4 Nov 2021
- Study start21 Oct 2021
- Primary completion19 Sep 2022
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 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
- NCT05106751
- Sponsor's protocol ID
- LG-HACL033
- Status last verified
- Aug 2023
- First submitted
- 24 Oct 2021
- Last updated
- 1 Nov 2023
- Results posted
- 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 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT05106751
- Acronym / sponsor ID
- LG-HACL033
- Conditions
- Correction of Nasolabial Folds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 4 Nov 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 Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.
Detailed description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YVOIRE Classic plus | Experimental | Device: Hyaluronic acid dermal filler |
| Restylane Lidocaine | Active comparator | Device: Hyaluronic acid dermal filler |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 21 years or above age.
- 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale).
- Agree to use proper contraception as guided in the protocol.
- Signed for Informed Consent.
Key exclusion criteria (7 listed)
- have received permanent facial implants anywhere in the face or neck or planning during the investigation.
- have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks
- have undergone semi-permanent filler in lower face
- have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months
- Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face
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 |
|---|---|---|
| Hyaluronic acid dermal fillerHyaluronic acid dermal filler used for facial volume or wrinkle correction | Device | Restylane Lidocaine, YVOIRE Classic plus |
Primary outcome
Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24.
Time frame: 24 weeks from baseline
To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme).
Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24.
Time frame: 24 weeks from baseline
To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated.
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 1 Nov 2023.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Hyaluronic acid dermal filler in people with Correction of Nasolabial Folds, run by LG Chem at 1 site in Germany.
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 7 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 1 Nov 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24. (time frame: 24 weeks from baseline). 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?
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 1 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.