- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02179619
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- 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
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Seoul, Korea, Republic of
- Eulji General Hospital
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Seoul, Korea, Republic of
- Chung-Ang University Hospital
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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
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects no younger than 30 and no more than 65 years of age.
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.
- Subjects who have symmetric nasolabial folds.
- Subjects who agreed to discontinue the use of any dermatological procedure or therapy, including facial wrinkle reduction procedures.
- Subjects with the ability to understand and follow the instructions and who are committed to availability for the entire study period.
- Subjects who have voluntarily decided to participate in this study and who have signed the informed consent form.
Exclusion Criteria:
- Subjects who show hypersensitive skin reaction to the investigational devices, confirmed by the intradermal reaction test performed at screening.
- 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.
- 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).
- 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.
- Subjects who have received treatment for wrinkles or acne within 24 weeks prior to screening.
- 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.
- Subjects who have a permanent skin expander such as soft form or silicon implanted in the face.
- 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.
- 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 |
Intervention / Treatment |
---|---|
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
|
Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
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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
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Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wrinkle Severity Rating Scale(WSRS) evaluation
Time Frame: at week 24
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Wrinkle Severity Rating Scale(WSRS) evaluation at week 24
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at week 24
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Secondary Outcome Measures
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
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Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 36, week 48 by independent evaluator
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at week 8~ 48
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The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group
Time Frame: at week 8~ 48
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Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 24, week 36, week 48 by investigator
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at week 8~ 48
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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
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Global Aesthetic Improvement Scale(GAIS) evaluation at week8, week 16, week 36, week 48 by investigator
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at week 8~48
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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
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Global Aesthetic Improvement Scale(GAIS) scores evaluation at week 8, 16, 24, 36, 48 by subjects
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at week 8~48
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The proportion of subjects whose WSRS scores decreased at least 1 level
Time Frame: at week 0~48
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the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by independent evaluator.
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at week 0~48
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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
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at week 0~48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
December 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
June 30, 2014
First Submitted That Met QC Criteria
June 30, 2014
First Posted (Estimate)
July 2, 2014
Study Record Updates
Last Update Posted (Estimate)
July 2, 2014
Last Update Submitted That Met QC Criteria
June 30, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Other Study ID 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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