Correction of Nasolabial FoldsPhase 3NCT02179606
Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus
A Phase 3 study testing Dermalax Implant Plus and Restylane Sub-Q in people with Correction of Nasolabial Folds, run by Across Co., Ltd. at 2 sites in South Korea.
Trial summary
This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Correction of Nasolabial Folds
- What is being tested?
- Dermalax Implant Plus and Restylane Sub-Q
- 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
- Jul 2013to Mar 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects no younger than 30 and no more than 75 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.
Who cannot join
- Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day)
- Subjects who have a history of bleeding disorder.
- Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chung-ang University Hospital
Seoul
Eulji General Hospital
Seoul
About this study
Official title: A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds
This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds
- Conditions
- Correction of Nasolabial Folds
- Being tested
- Dermalax Implant Plus, Restylane Sub-Q
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermalax Implant PlusDevice
Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
Restylane Sub-QDevice
Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Dermalax Implant Plus | Experimental | Subject injected in the nasolabial folds of one side of the face in the initial treatment period. Receives: Device: Dermalax Implant Plus; Device: Restylane Sub-Q |
| Restylane Sub-Q | Active comparator | Subject injected in the nasolabial folds of one side of the face in the initial treatment period. Receives: Device: Dermalax Implant Plus; Device: Restylane Sub-Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group
Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos.
Measured: baseline, week 12
Secondary outcomes (3)
Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group
Improvement of wrinkle severity system scale(WSRS) scores at week2, week8, week 16, week 24 compared to baseline by independent evaluator using photos.
Measured: baseline, at week 2~24
Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved
Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved at week2, week 8, week 12, week 16, week 24 evaluated by investigator at site
Measured: at week 2~24
100 mm visual analogue scale (VAS) scores evaluation
100 mm visual analogue scale (VAS) scores at both nasolabial folds evaluated by subjects at application of the devices
Measured: week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJul 2013
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correction of Nasolabial FoldsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Across Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beom Joon Kim, MD, Principal investigator, Chung-Ang University HospitalJong Hoon Lee, MD, Principal investigator, Eulji General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179606
- Sponsor's protocol ID
- AC-13-01
- Status last verified
- Mar 2014
- First submitted
- 30 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT02179606
- Acronym / sponsor ID
- AC-13-01
- Conditions
- Correction of Nasolabial Folds
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Across Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 2 Jul 2014 (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 study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermalax Implant Plus | Experimental | Device: Dermalax Implant Plus, Device: Restylane Sub-QSubject injected in the nasolabial folds of one side of the face in the initial treatment period. |
| Restylane Sub-Q | Active comparator | Device: Dermalax Implant Plus, Device: Restylane Sub-QSubject injected in the nasolabial folds of one side of the face in the initial treatment period. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects no younger than 30 and no more than 75 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.
Key exclusion criteria (3 listed)
- Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day)
- Subjects who have a history of bleeding disorder.
- Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.
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 |
|---|---|---|
| Dermalax Implant PlusDermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period. | Device | Dermalax Implant Plus, Restylane Sub-Q |
| Restylane Sub-QRestylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period. | Device | Dermalax Implant Plus, Restylane Sub-Q |
Primary outcome
Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group
Time frame: baseline, week 12
Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos.
3 secondary outcomes
Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group
Time frame: baseline, at week 2~24
Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved
Time frame: at week 2~24
100 mm visual analogue scale (VAS) scores evaluation
Time frame: week 0
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 8 Jul 2014.
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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.
Beom Joon Kim, MD principal investigator
Chung-Ang University Hospital
Jong Hoon Lee, MD principal investigator
Eulji General Hospital
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 Dermalax Implant Plus and Restylane Sub-Q in people with Correction of Nasolabial Folds, run by Across Co., Ltd. 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 4 inclusion and 3 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 8 Jul 2014. 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?
Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group (time frame: baseline, week 12). 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 8 Jul 2014.