Nasolabial Fold ImprovementNCT01918839
Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler
A study testing VINCI Plus and Restylane-L in people with Nasolabial Fold Improvement, run by D.med at 2 sites in South Korea.
Trial summary
This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI Plus as compared to Restylane-L® in correction of nasolabial fold. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold Improvement
- What is being tested?
- VINCI Plus and Restylane-L
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Feb 2014to Jun 2014
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 30-65, at the point of screening, wrinkles on both sides of treatment area (nasolabial fold) are in the 3rd or 4th level on the WSRS(Wrinkle Severity Rating Score)
- Surrounding soft tissue of wrinkles on both sides of nose and lips are sagging
- Wrinkles of both sides of nose and lips are visually symmetric
- Agrees to stop all other treatment of facial wrinkle improvement including dermatology treatment during clinical trial
- Able to understand and follow instructions and participate the entire period of the clinical trial
- Subject voluntarily agrees to participate in clinical trial and gives informed written consent
Who cannot join
- At the point of screening, intradermal test results show skin irritation to medical devices of clinical trial
- Within 2 weeks before the date of screening, subject has taken antithrombotic (with the exception of low dose aspirin 100mg, up to 300mg/day) or non-steroidal anti-inflammatory medication
- Case where subject has abnormal liver function or blood coagulation, has to take antithrombotic medication (with the exception of low dose aspirin 100mg, up to 300mg/day) during clinical trial
- Subject has used facial topical liniment (steroids, retinoids: excluding only medicines and cosmetics) within 4 weeks before date of screening or plans to continue using facial topical liniment during clinical trial
- Within 6 months before date of screening, subject has received anti-wrinkle or acne treatment
- Within 6 months before date of screening, subject has received facial microdermabrasion treatment, skin regeneration/rejuvenation treatment, plastic surgery, or cosmetic surgery (including Botox injections)
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- Within 1 year before date of screening, subject has received CaHA (Calcium Hydroxyapatite) treatment on clinical trial medical device treatment area
- Subject has cured facial gel (Softform) or silicone implants inserted as permanent facial expansion
- Within 1 year before, subject had an illness that caused scarring or has scars on clinical trial medical device treatment area
- Subject has facial skin disease or skin wound infection that affects the clinical trial
- Weak immune system or suspect that the immune system is weak
- History of anaphylaxis or severe allergic complexity
- History of hypertrophic scar or keloid
- In the past, if there were adverse effects from EMLA Cream (if EMLA Cream was not used, the exclusion criteria for subjects applicable)
- History of hypersensitivity to Lidocaine
- Cardiovascular, digestive, respiratory, endocrine, central nervous system disorders that seems clinically significant or had a mental illness that had a significant impact on a previous clinical trial or currently has a mental illness
- Within 30 days before screening, subject participated in other clinical trials
- Female subjects of childbearing potential does not agree to a medically accepted method of contraception for the period of the clinical trial Medically acceptable methods of contraception: condoms; oral contraception continued for at least three months; or if intrauterine is used, installed a contraceptive device
- Pregnant women or nursing mothers
- In addition to the above, the test director or person in charge medically judges there are clinically significant findings that are improper for the clinical trial
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seongnam-si, Gyeonggi-do
Chung-Ang University Hospital
Seoul
About this study
Official title: Clinical Study to Evaluate the Efficacy and Safety of Injection With VINCI Plus as Compared to Restylane-L in Correction of Nasolabial Fold
This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI Plus as compared to Restylane-L® in correction of nasolabial fold.
- Conditions
- Nasolabial Fold Improvement
- Being tested
- VINCI Plus, Restylane-L
- Keywords
- Investigational Device (VINCI Plus), Correction of nasolabial fold, Wrinkle improvement, Wrinkle correction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VINCI PlusDevice
VINCI Plus 1ml injected into wrinkle treatment area
Restylane-LDevice
Restylane-L injected into wrinkle treatment area
| Study group | Role | What they receive |
|---|---|---|
| VINCI Plus | Experimental | One side has been treated with VINCI Plus Receives: Device: VINCI Plus |
| Restylane-L | Active comparator | One side has been treated with Restylane-L Receives: Device: Restylane-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle Severity Rating Scale (WSRS) Evaluation
Wrinkle Severity Rating Scale (WSRS) evaluation at 12 weeks
Measured: At 12 weeks
Secondary outcomes (3)
Wrinkle Severity Rating Scale (WSRS) Evaluation
Wrinkle Severity Rating Scale (WSRS) Evaluation at 2 weeks, and 6 weeks.
Measured: At 2 weeks, 6 weeks
Global Aesthetic Improvement Scale (GAIS) Evaluation
Global Aesthetic Improvement Scale (GAIS) Evaluation at 2 weeks, 6 weeks and 12 weeks.
Measured: At 2 weeks, 6 weeks and 12 weeks
VAS pain assessment at each time point
VAS pain assessment at each time point (at injection and 15, 30, 45, and 60 min after injection)
Measured: at injection and 15, 30, 45, and 60 min after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold ImprovementStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- D.med
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chung-Ang University Hospital, Seoul National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918839
- Sponsor's protocol ID
- DMEDVINCI001
- Other IDs
- DMEDVINCI001
- Status last verified
- Dec 2023
- First submitted
- 2 Aug 2013
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy and Safety of Injection With VINCI Plus as Compared to Restylane-L in Correction of Nasolabial Fold
- ClinicalTrials.gov ID
- NCT01918839
- Acronym / sponsor ID
- DMEDVINCI001
- Conditions
- Nasolabial Fold Improvement
- Keywords
- Investigational Device (VINCI Plus), Correction of nasolabial fold, Wrinkle improvement, Wrinkle correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- D.medIndustry (pharma, biotech, devices)
- Collaborators
- Chung-Ang University Hospital, Seoul National University Hospital
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Aug 2013 (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.
This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI Plus as compared to Restylane-L® in correction of nasolabial fold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VINCI Plus | Experimental | Device: VINCI PlusOne side has been treated with VINCI Plus |
| Restylane-L | Active comparator | Device: Restylane-LOne side has been treated with Restylane-L |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female between the ages of 30-65, at the point of screening, wrinkles on both sides of treatment area (nasolabial fold) are in the 3rd or 4th level on the WSRS(Wrinkle Severity Rating Score)
- Surrounding soft tissue of wrinkles on both sides of nose and lips are sagging
- Wrinkles of both sides of nose and lips are visually symmetric
- Agrees to stop all other treatment of facial wrinkle improvement including dermatology treatment during clinical trial
- Able to understand and follow instructions and participate the entire period of the clinical trial
Key exclusion criteria (20 listed)
- At the point of screening, intradermal test results show skin irritation to medical devices of clinical trial
- Within 2 weeks before the date of screening, subject has taken antithrombotic (with the exception of low dose aspirin 100mg, up to 300mg/day) or non-steroidal anti-inflammatory medication
- Case where subject has abnormal liver function or blood coagulation, has to take antithrombotic medication (with the exception of low dose aspirin 100mg, up to 300mg/day) during clinical trial
- Subject has used facial topical liniment (steroids, retinoids: excluding only medicines and cosmetics) within 4 weeks before date of screening or plans to continue using facial topical liniment during clinical trial
- Within 6 months before date of screening, subject has received anti-wrinkle or acne treatment
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 |
|---|---|---|
| VINCI PlusVINCI Plus 1ml injected into wrinkle treatment area | Device | VINCI Plus |
| Restylane-LRestylane-L injected into wrinkle treatment area | Device | Restylane-L |
Primary outcome
Wrinkle Severity Rating Scale (WSRS) Evaluation
Time frame: At 12 weeks
Wrinkle Severity Rating Scale (WSRS) evaluation at 12 weeks
3 secondary outcomes
Wrinkle Severity Rating Scale (WSRS) Evaluation
Time frame: At 2 weeks, 6 weeks
Global Aesthetic Improvement Scale (GAIS) Evaluation
Time frame: At 2 weeks, 6 weeks and 12 weeks
VAS pain assessment at each time point
Time frame: at injection and 15, 30, 45, and 60 min after injection
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 5 Dec 2023.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VINCI Plus and Restylane-L in people with Nasolabial Fold Improvement, run by D.med 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 20 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 5 Dec 2023. 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.
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?
Wrinkle Severity Rating Scale (WSRS) Evaluation (time frame: At 12 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 5 Dec 2023.