Nasolabial FoldsNCT03753152
Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
A study testing experimental and comparator in people with Nasolabial Folds, run by Medy-Tox at 1 site in China.
Trial summary
This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- experimental and comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2018to 16 Oct 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 75 years of age.
- Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.
Who cannot join
- Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
- Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.
Read the detailed description
Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.
- Conditions
- Nasolabial Folds
- Being tested
- experimental, comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentalDevice
Neuramis® Deep Lidocaine
comparatorDevice
YVOIRE® Volume Plus
| Study group | Role | What they receive |
|---|---|---|
| Investigational medical device | Experimental | Neuramis® Deep Lidocaine Receives: Device: experimental |
| Comparator device | Active comparator | YVOIRE® Volume Plus Receives: Device: comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS improvement rate at Week 24
WSRS improvement rate at Week 24
Measured: Week 24
Secondary outcomes (3)
Change of WSRS from Week 4, 12, 24, 36, and 52
Change of WSRS from Week 4, 12, 24, 36, and 52
Measured: Week 4, 12, 24, 36, and 52
WSRS improvement rate on Week 4, 12, 36, and 52
WSRS improvement rate on Week 4, 12, 36, and 52
Measured: Week 4, 12, 36, and 52
GAIS improvement rate on Week 4, 12, 24, 36, and 52
GAIS improvement rate on Week 4, 12, 24, 36, and 52
Measured: Week 4, 12, 24, 36, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start2 Apr 2018
- Primary completion2 Apr 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinhua XU, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753152
- Sponsor's protocol ID
- MT07-CN16NLF701
- Status last verified
- Jul 2020
- First submitted
- 22 Nov 2018
- Last updated
- 28 Jul 2020
- 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03753152
- Acronym / sponsor ID
- MT07-CN16NLF701
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 26 Nov 2018 (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 clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.
Detailed description
Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational medical device | Experimental | Device: experimentalNeuramis® Deep Lidocaine |
| Comparator device | Active comparator | Device: comparatorYVOIRE® Volume Plus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, 18 to 75 years of age.
- Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.
Key exclusion criteria (2 listed)
- Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
- Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.
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 |
|---|---|---|
| experimentalNeuramis® Deep Lidocaine | Device | Investigational medical device |
| comparatorYVOIRE® Volume Plus | Device | Comparator device |
Primary outcome
WSRS improvement rate at Week 24
Time frame: Week 24
WSRS improvement rate at Week 24
3 secondary outcomes
Change of WSRS from Week 4, 12, 24, 36, and 52
Time frame: Week 4, 12, 24, 36, and 52
WSRS improvement rate on Week 4, 12, 36, and 52
Time frame: Week 4, 12, 36, and 52
GAIS improvement rate on Week 4, 12, 24, 36, and 52
Time frame: Week 4, 12, 24, 36, and 52
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 28 Jul 2020.
- 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.
Jinhua XU principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental and comparator in people with Nasolabial Folds, run by Medy-Tox 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 2 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 28 Jul 2020. 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 improvement rate at Week 24 (time frame: Week 24). 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 28 Jul 2020.