AgingNCT02721368
Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume
A study testing Neuramis® Volume Lidocaine and Juvederm® Voluma® with Lidocaine in people with Aging, run by Medy-Tox at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Neuramis® Volume Lidocaine and Juvederm® Voluma® with Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2016to 11 Sep 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject aged between 35 and 65.
- Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level
- Participated in the pivotal study and completed the end of study visit
- Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study
Who cannot join
- Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
- Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
- Those who has thin skin in the mid-facial area
- Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics
- <Extension Study>
- Those who have following procedual history between completion of the pivotal study and entry of extension study
- facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting
- Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chung-Ang Univ. Medical Center
Seoul, Dongjak-gu, 156-755
About this study
Official title: Clinical Study of Neuramis® Volume Lidocaine to Evaluate the Efficacy and Safety for Temporary Restoring the Mid-face Volume
The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.
Read the detailed description
This is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. The subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (Neuramis® Volume Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.
- Conditions
- Aging
- Being tested
- Neuramis® Volume Lidocaine, Juvederm® Voluma® with Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuramis® Volume LidocaineDevice
hyaluronic acid filler
Juvederm® Voluma® with LidocaineDevice
hyaluronic acid filler
| Study group | Role | What they receive |
|---|---|---|
| Investigational medical device | Experimental | Neuramis® Volume Lidocaine Receives: Device: Neuramis® Volume Lidocaine |
| Comparator medical device | Active comparator | Juvederm® Voluma® with Lidocaine Receives: Device: Juvederm® Voluma® with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
MFVDS 0- None, 1-Minimal, 2-Mild, 3-Moderate, 4-Significant, 5-Severe The lower score, the better condition.
Measured: 24 weeks
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
Primary outcome for extension study
Measured: 104 weeks
Secondary outcomes (2)
The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit
Measured: 104 weeks
Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start3 Nov 2016
- Primary completion31 Oct 2017
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BeomJoon Kim, Principal investigator, Chung-Ang Univ. Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721368
- Sponsor's protocol ID
- MT_PRT_MVD01
- Status last verified
- Oct 2020
- First submitted
- 14 Mar 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Neuramis® Volume Lidocaine to Evaluate the Efficacy and Safety for Temporary Restoring the Mid-face Volume
- ClinicalTrials.gov ID
- NCT02721368
- Acronym / sponsor ID
- MT_PRT_MVD01
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 29 Mar 2016 (estimated)
- 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.
The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.
Detailed description
This is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. The subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (Neuramis® Volume Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.
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: Neuramis® Volume LidocaineNeuramis® Volume Lidocaine |
| Comparator medical device | Active comparator | Device: Juvederm® Voluma® with LidocaineJuvederm® Voluma® with Lidocaine |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject aged between 35 and 65.
- Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level
- Participated in the pivotal study and completed the end of study visit
- Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study
Key exclusion criteria (8 listed)
- Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
- Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
- Those who has thin skin in the mid-facial area
- Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics
- <Extension Study>
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 |
|---|---|---|
| Neuramis® Volume Lidocainehyaluronic acid filler | Device | Investigational medical device |
| Juvederm® Voluma® with Lidocainehyaluronic acid filler | Device | Comparator medical device |
Primary outcome
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
Time frame: 24 weeks
MFVDS 0- None, 1-Minimal, 2-Mild, 3-Moderate, 4-Significant, 5-Severe The lower score, the better condition.
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
Time frame: 104 weeks
Primary outcome for extension study
2 secondary outcomes
The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit
Time frame: 104 weeks
Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)
Time frame: 104 weeks
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 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
BeomJoon Kim principal investigator
Chung-Ang Univ. Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuramis® Volume Lidocaine and Juvederm® Voluma® with Lidocaine in people with Aging, run by Medy-Tox at 1 site in South Korea.
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 8 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 14 Oct 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 South Korea. 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?
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS) (time frame: 24 weeks). 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 14 Oct 2020.