Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler

December 3, 2023 updated by: D.med

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Chung-Ang University Hospital
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VINCI Plus
One side has been treated with VINCI Plus
Device: VINCI Plus
VINCI Plus 1ml injected into wrinkle treatment area
Active Comparator: Restylane-L
One side has been treated with Restylane-L
Device: Restylane-L
Restylane-L injected into wrinkle treatment area

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wrinkle Severity Rating Scale (WSRS) Evaluation
Time Frame: At 12 weeks
Wrinkle Severity Rating Scale (WSRS) evaluation at 12 weeks
At 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wrinkle Severity Rating Scale (WSRS) Evaluation
Time Frame: At 2 weeks, 6 weeks
Wrinkle Severity Rating Scale (WSRS) Evaluation at 2 weeks, and 6 weeks.
At 2 weeks, 6 weeks
Global Aesthetic Improvement Scale (GAIS) Evaluation
Time Frame: At 2 weeks, 6 weeks and 12 weeks
Global Aesthetic Improvement Scale (GAIS) Evaluation at 2 weeks, 6 weeks and 12 weeks.
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
VAS pain assessment at each time point (at injection and 15, 30, 45, and 60 min after injection)
at injection and 15, 30, 45, and 60 min after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
D.med

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seoul National University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2013

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMEDVINCI001 (Other Identifier: D. Med)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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