Clinical Study to Evaluate the Efficacy and Safety of Dermalax(Deep) in Correction of Nasolabial Folds

June 30, 2014 updated by: Across Co., Ltd.

A Randomized, Multi-center, Patient & Evaluator-blind, Matched Pairs, Active-controlled Design Clinical Study to Evaluate the Efficacy and Safety of Injection With Dermalax(Deep) as Compared to Restylane® in Correction of Nasolabial Fold

The study is to verify that Dermalax (Deep) is not inferior to the reference device, Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subject diary and follow up visits.

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.
66

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.
  • Phase 3

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
        • Eulji General Hospital
      • Seoul, Korea, Republic of
        • Chung-Ang 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects no younger than 30 and no more than 65 years of age.

  2. Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.*)

    *The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4.

  3. Subjects who have symmetric nasolabial folds.
  4. Subjects who agreed to discontinue the use of any dermatological procedure or therapy, including facial wrinkle reduction procedures.
  5. Subjects with the ability to understand and follow the instructions and who are committed to availability for the entire study period.
  6. Subjects who have voluntarily decided to participate in this study and who have signed the informed consent form.

Exclusion Criteria:

  1. Subjects who show hypersensitive skin reaction to the investigational devices, confirmed by the intradermal reaction test performed at screening.
  2. Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin 100 mg, maximum of 300 mg/day) or NSAIDs or Vitamin E within 1 week.
  3. Subjects with a liver problem and/or blood coagulation defect or subjects who require the administration of an antithrombotic agent during the clinical trial period (with the exception of low dose Aspirin 100 mg, maximum of 300 mg/day).
  4. Subjects who have used a local ointment on their faces (medication such as steroid or retinoid are included and cosmetic products are excluded from this criterion) within 4 weeks prior to screening or subjects who are planning on using such an ointment during the clinical trial period.
  5. Subjects who have received treatment for wrinkles or acne within 24 weeks prior to screening.
  6. Subjects who have received facial (chemical) peels and/or skin rejuvenation procedures or plastic surgeries, including the injection of the Botulinum toxin, within 24 weeks prior to screening.
  7. Subjects who have a permanent skin expander such as soft form or silicon implanted in the face.
  8. Subjects who have scars on the face requiring a medical treatment but who have not received any treatment for more than a year or subjects who have scars or wounds on which the test investigational devices will be applied.
  9. Subjects with skin disease or wound infection on the face.

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: Dermalax(Deep)
subject injected in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period
Device: Dermalax(Deep)
Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
Device: Restylane
Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
Active Comparator: Restylane
Subject injected in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period
Device: Dermalax(Deep)
Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
Device: Restylane
Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

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 week 24
Wrinkle Severity Rating Scale(WSRS) evaluation at week 24
at week 24

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
The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group
Time Frame: at week 8~ 48
Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 36, week 48 by independent evaluator
at week 8~ 48
The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group
Time Frame: at week 8~ 48
Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 24, week 36, week 48 by investigator
at week 8~ 48
The mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group
Time Frame: at week 8~48
Global Aesthetic Improvement Scale(GAIS) evaluation at week8, week 16, week 36, week 48 by investigator
at week 8~48
Mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group
Time Frame: at week 8~48
Global Aesthetic Improvement Scale(GAIS) scores evaluation at week 8, 16, 24, 36, 48 by subjects
at week 8~48
The proportion of subjects whose WSRS scores decreased at least 1 level
Time Frame: at week 0~48
the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by independent evaluator.
at week 0~48
The proportion of subjects whose WSRS scores decreased at least 1 level
Time Frame: at week 0~48
the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by investigator
at week 0~48

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.
Across Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beom Joon Kim, PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
  • Principal Investigator: Jong Hoon Lee, PhD, Eulji General Hospital

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.
December 1, 2012

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.
January 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.
February 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).
June 30, 2014

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.
June 30, 2014

First Posted (Estimate)

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.
July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
July 2, 2014

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.
June 30, 2014

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.
June 1, 2014

More Information

Terms related to this study

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.
  • HG-HADNSF-12103

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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