Nasolabial FoldPhase 3NCT02751034
Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold
A Phase 3 study testing Neuramis® Deep Lidocaine and Restylane® PERLANE-L in people with Nasolabial Fold, run by Medy-Tox at 2 sites in South Korea.
Trial summary
The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Nasolabial Fold
- What is being tested?
- Neuramis® Deep Lidocaine and Restylane® PERLANE-L
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2013to Jan 2014
- Phase
- Phase 3
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female aged between 30 and 70 years, inclusive
- Subjects who want improvement of bilateral nasolabial folds that are rated as 3 or 4 points on Wrinkle Severity Rating Scale
- Subjects with visually symmetrical bilateral nasolabial folds
- Subjects who consent to abstain from wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial
- Subjects who are capable of understanding and following instructions, and participating in the entire course of the trial
- Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form
Who cannot join
- Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening
- Subjects who had face-lift, soft tissue augmentation, medium or deeper peeling, or dermal photo-rejuvenation on the lower face (lower orbital rim) for wrinkle improvement within 6 months prior to screening
- Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening
- Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon
- Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect
- Subjects with a history of anaphylaxis or severe complicated allergy or allergy to lidocaine or hyaluronic acid products
Show all 11Show fewer
- Subjects with a history of a hypertrophic scar or keloid
- Subjects with a skin disease or wound infection at the investigational medical device injection site
- Subjects who participated in another clinical trial within 30 days prior to screening
- Pregnant or breastfeeding women or women of childbearing potential who are not using medically acceptable contraception or not consenting to practice birth control from screening to the end of trial
- Subjects who are otherwise determined by the investigator as ineligible for this study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Catholic University St. Paul Hospital
Seoul, Dongdaemun-gu, 130-709
Chung-Ang Univ. Medical Center
Seoul, Dongjak-gu, 156-755
About this study
Official title: A Randomized, Multi-center, Double Blind, Intra-Individual Controlled, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis® Deep Lidocaine as Compared to Restylane® PERLANE-L in Correction of Nasolabial Fold
The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds
Read the detailed description
This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial.
Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.
- Conditions
- Nasolabial Fold
- Being tested
- Neuramis® Deep Lidocaine, Restylane® PERLANE-L
- Keywords
- Wrinkle Severity Rating Scale, Global Aesthetic Improvement Scale, Hyaluronic acid filler, filler, Nasolabial Fold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuramis® Deep LidocaineDevice
HA filler
Restylane® PERLANE-LDevice
HA filler
| Study group | Role | What they receive |
|---|---|---|
| Neuramis® Deep Lidocaine | Experimental | Neuramis® Deep Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection Receives: Device: Neuramis® Deep Lidocaine |
| Restylane® PERLANE-L | Active comparator | Restylane® PERLANE-L Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection Receives: Device: Restylane® PERLANE-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
Measured: from baseline to 24 weeks
Secondary outcomes (8)
Change on Wrinkle Severity Rating Scale as evaluated by an investigator
Measured: from baseline to 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by an investigator
Measured: from baseline to 8, 16, 24 weeks
Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
Measured: from baseline to 8, 16 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by photograph raters
Measured: from baseline to 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator
Measured: 8, 16, 24 weeks after the injection
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject
Measured: 8, 16, 24 weeks after the injection
Visual Analogue Scale as evaluated by a subject
Measured: at 15, 30, 45, 60 minutes after the injection
Vital signs, physical examination, laboratory tests and adverse events
Measured: from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hoon Kang, Principal investigator, Catholic University St. Paul HospitalBeomJoon Kim, Principal investigator, Chung-Ang Univ. Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751034
- Sponsor's protocol ID
- MT_PRT_NLF02
- Status last verified
- Apr 2016
- First submitted
- 21 Apr 2015
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Double Blind, Intra-Individual Controlled, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis® Deep Lidocaine as Compared to Restylane® PERLANE-L in Correction of Nasolabial Fold
- ClinicalTrials.gov ID
- NCT02751034
- Acronym / sponsor ID
- MT_PRT_NLF02
- Conditions
- Nasolabial Fold
- Keywords
- Wrinkle Severity Rating Scale, Global Aesthetic Improvement Scale, Hyaluronic acid filler, filler, Nasolabial Fold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Apr 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 efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds
Detailed description
This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial.
Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuramis® Deep Lidocaine | Experimental | Device: Neuramis® Deep LidocaineNeuramis® Deep Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection |
| Restylane® PERLANE-L | Active comparator | Device: Restylane® PERLANE-LRestylane® PERLANE-L Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female aged between 30 and 70 years, inclusive
- Subjects who want improvement of bilateral nasolabial folds that are rated as 3 or 4 points on Wrinkle Severity Rating Scale
- Subjects with visually symmetrical bilateral nasolabial folds
- Subjects who consent to abstain from wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial
- Subjects who are capable of understanding and following instructions, and participating in the entire course of the trial
Key exclusion criteria (11 listed)
- Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening
- Subjects who had face-lift, soft tissue augmentation, medium or deeper peeling, or dermal photo-rejuvenation on the lower face (lower orbital rim) for wrinkle improvement within 6 months prior to screening
- Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening
- Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon
- Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect
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® Deep LidocaineHA filler | Device | Neuramis® Deep Lidocaine |
| Restylane® PERLANE-LHA filler | Device | Restylane® PERLANE-L |
Primary outcome
Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
Time frame: from baseline to 24 weeks
8 secondary outcomes
Change on Wrinkle Severity Rating Scale as evaluated by an investigator
Time frame: from baseline to 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by an investigator
Time frame: from baseline to 8, 16, 24 weeks
Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs
Time frame: from baseline to 8, 16 weeks
Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by photograph raters
Time frame: from baseline to 8, 16, 24 weeks
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator
Time frame: 8, 16, 24 weeks after the injection
Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject
Time frame: 8, 16, 24 weeks after the injection
Visual Analogue Scale as evaluated by a subject
Time frame: at 15, 30, 45, 60 minutes after the injection
Vital signs, physical examination, laboratory tests and adverse events
Time frame: from baseline to 24 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 26 Apr 2016.
- 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.
Hoon Kang principal investigator
Catholic University St. Paul Hospital
BeomJoon Kim principal investigator
Chung-Ang Univ. Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neuramis® Deep Lidocaine and Restylane® PERLANE-L in people with Nasolabial Fold, run by Medy-Tox at 2 sites 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 6 inclusion and 11 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs (time frame: from baseline to 24 weeks). 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 26 Apr 2016.