Mid Face Volume LossNCT03754413
Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face
A study testing experimental and comparator in people with Mid Face Volume Loss, run by Medy-Tox at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mid Face Volume Loss
- 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
- 236 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2018to 9 Mar 2020
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 20 to 75 years of age
- Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale
Who cannot join
- Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
- Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized, Evaluator-Blinded, "No Treatment" Controlled Study to Evaluate the Effectiveness and Safety of Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face
To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.
Read the detailed description
This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236 male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume augmentation to correct deficit in their mid-face volume.
- Conditions
- Mid Face Volume Loss
- 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
comparatorDrug
No-treatment
| Study group | Role | What they receive |
|---|---|---|
| Investigational medical device | Experimental | Neuramis® Volume Lidocaine Receives: Device: experimental |
| Comparator device | Other | No-treatment Receives: Drug: comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Facial Volume Scale(FVS) improvement rate at Week 24
Facial Volume Scale score ranges from 0-5 with higher score indicating increasing severity of mid-face volume deficit / Proportion of subjects with Facial Volume Scale(FVS) showing ≥1-point improvement (Facial Volume Scale decrease ≥1) at Week 24 compared to Baseline
Measured: Week 24
Secondary outcomes (3)
6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52
The proportion of subjects with 6-point Facial Volume Scale(FVS) decrease ≥1 from Baseline as assessed at Weeks 4, 12, 36, and 52.
Measured: Weeks 4, 12, 36, and 52
Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52
Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52
Measured: Weeks 4, 12, 24, 36, and 52
Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52
Global Aesthetic Improvement Scale(GAIS) improvement rate is defined as the proportion of subjects with GAIS score ≤3
Measured: Weeks 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 posted27 Nov 2018
- Study start29 May 2018
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid Face Volume LossStudies 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754413
- Sponsor's protocol ID
- MT08-CN16MFV702
- Status last verified
- Mar 2021
- First submitted
- 22 Nov 2018
- Last updated
- 19 Mar 2021
- 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 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized, Evaluator-Blinded, "No Treatment" Controlled Study to Evaluate the Effectiveness and Safety of Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face
- ClinicalTrials.gov ID
- NCT03754413
- Acronym / sponsor ID
- MT08-CN16MFV702
- Conditions
- Mid Face Volume Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 27 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.
To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.
Detailed description
This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236 male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume augmentation to correct deficit in their mid-face volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational medical device | Experimental | Device: experimentalNeuramis® Volume Lidocaine |
| Comparator device | Other | Drug: comparatorNo-treatment |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female 20 to 75 years of age
- Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale
Key exclusion criteria (2 listed)
- Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
- Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.
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 |
| comparatorNo-treatment | Drug | Comparator device |
Primary outcome
Total Facial Volume Scale(FVS) improvement rate at Week 24
Time frame: Week 24
Facial Volume Scale score ranges from 0-5 with higher score indicating increasing severity of mid-face volume deficit / Proportion of subjects with Facial Volume Scale(FVS) showing ≥1-point improvement (Facial Volume Scale decrease ≥1) at Week 24 compared to Baseline
3 secondary outcomes
6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52
Time frame: Weeks 4, 12, 36, and 52
Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52
Time frame: Weeks 4, 12, 24, 36, and 52
Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52
Time frame: Weeks 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 19 Mar 2021.
Related trials for Mid Face Volume Loss
Active, not recruiting
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Dermal Fillers, Cheek Augmentation
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 experimental and comparator in people with Mid Face Volume Loss, 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 19 Mar 2021. 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?
Total Facial Volume Scale(FVS) 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 19 Mar 2021.