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Correction of Nasolabial FoldsPhase 3NCT02179619

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

A Phase 3 study testing Dermalax(Deep) and Restylane in people with Correction of Nasolabial Folds, run by Across Co., Ltd. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Correction of Nasolabial Folds
What is being tested?
Dermalax(Deep) and Restylane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesSouth Korea
Study dates
Dec 2012to Feb 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 65 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 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Chung-ang University Hospital

    Seoul

  • Eulji General Hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Being tested
Dermalax(Deep), Restylane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dermalax(Deep)Device

    Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

  • RestylaneDevice

    Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

Study groups in NCT02179619
Study groupRoleWhat they receive
Dermalax(Deep)Experimentalsubject injected in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period
Receives: Device: Dermalax(Deep); Device: Restylane
RestylaneActive comparatorSubject injected in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period
Receives: Device: Dermalax(Deep); Device: Restylane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wrinkle Severity Rating Scale(WSRS) evaluation

    Wrinkle Severity Rating Scale(WSRS) evaluation at week 24

    Measured: at week 24

Secondary outcomes (6)

  1. The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group

    Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 36, week 48 by independent evaluator

    Measured: at week 8~ 48

  2. The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group

    Wrinkle severity system scale(WSRS) evaluation at week8, week 16, week 24, week 36, week 48 by investigator

    Measured: at week 8~ 48

  3. The mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group

    Global Aesthetic Improvement Scale(GAIS) evaluation at week8, week 16, week 36, week 48 by investigator

    Measured: at week 8~48

  4. Mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group

    Global Aesthetic Improvement Scale(GAIS) scores evaluation at week 8, 16, 24, 36, 48 by subjects

    Measured: at week 8~48

  5. The proportion of subjects whose WSRS scores decreased at least 1 level

    the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by independent evaluator.

    Measured: at week 0~48

  6. The proportion of subjects whose WSRS scores decreased at least 1 level

    the proportion of subjects whose Wrinkle severity system scale(WSRS) scores decreased at least 1 level at week 24, 36, 48 by investigator

    Measured: at week 0~48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2014 (estimated)
  2. Study startDec 2012
  3. Primary completionJan 2014
  4. Study completionFeb 2014

Resources

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
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02179619
Sponsor's protocol ID
HG-HADNSF-12103
Status last verified
Jun 2014
First submitted
30 Jun 2014
Last updated
2 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dermalax(Deep) and Restylane 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 7 inclusion and 9 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 2 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?

Wrinkle Severity Rating Scale(WSRS) evaluation (time frame: at week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02179619.

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 2 Jul 2014.

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