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Nasolabial FoldPhase 3NCT01585220

Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

A Phase 3 study testing HA filler in people with Nasolabial Fold, run by Medy-Tox 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

This study design is a randomized, multi-center, double Masked, matched Pairs, active-controlled clinical trial. 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. Read more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Nasolabial Fold
What is being tested?
HA filler
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
2 sitesSouth Korea
Study dates
9 Feb 2012to 30 Oct 2012
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

  • Men and women aged between 30 and 75
  • Subjects who wanting to correct his/her nasolabial fold and attaining grade 3 or 4 in the Wrinkle Severity Rating Scale(WSRS) of nasolabial fold
  • Subjects whose nasolabial folds are visually symmetric
  • Subjects who agreed to restrict any treatment for the wrinkle correction at the lower orbital rim area for the duration of the study
  • Subjects who can understand and comply with the instructions and all visit schedule
  • Subjects who voluntarily decided the participation of the study and signed the informed consent

Who cannot join

  • Subjects who had anti-coagulant therapy(excluding low-dose aspirin therapy(100mg, maximum 300mg/day dose)) within 2 weeks from the screening date
  • Subjects who had previous treatment at the lower orbital rim for wrinkle correction(e.g., face lift, soft tissue augmentation, medium depth peels, dermal photorejuvenation) within 6 months from screening date
  • Subjects who were treated calcium hydroxyapatite at the NLF area within a year from screening date
  • Subjects who had dermal augmentation permanent implants(e.g., silicone, Softform®) at the NLF area
  • Subjects who have a scar or skin lesion which can be affect to efficacy to the NLF area
  • Subjects who had anaphylaxis or severe combined allergy or allergy to lidocain or hyaluronic acid
Show all 12Show fewer
  • Subjects who had a history of keloid formation or hypertrophic scar
  • Subjects who have a skin disorder or wound infection in the NLF area
  • Subjects who participated in other clinical trial within 30 days from screening date
  • The childbearing subjects who disagreed with medically acceptable contraception(e.g., condom, oral contraceptives continuing at least 3 months, contraceptives for injection or insertion, intrauterine contraceptive devices)
  • Pregnant or lactating subjects
  • Patients who are not eligible for this study at the medical discretion of the investigator

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul National University Bundang Hospital

    Seongnam, Gyunggi, 463-707

  • Samsung Medical Center

    Seoul, Gangnam, 135-710

Other trials in South Korea

About this study

Official title: A Randomized, Multi-center, Double Masked, Matched Pairs, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis as Compared to Restylane® in Correction of Nasolabial Fold

This study design is a randomized, multi-center, double Masked, matched Pairs, active-controlled clinical trial. 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 subeject diary and follow up visits.

Conditions
Nasolabial Fold
Being tested
HA filler
Keywords
WSRS, GAIS, HA filler, filler

What participants receive

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

  • HA fillerDevice

    The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.

Study groups in NCT01585220
Study groupRoleWhat they receive
NeuramisExperimentalNot described
Receives: Device: HA filler
Restylane®Active comparatorNot described
Receives: Device: HA filler

What is being measured

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

  1. WSRS

    The change between baseline and 24 weeks WSRS evaluated by the investigator in charge of live assessment

    Measured: 24 weeks after the injection

Secondary outcomes (7)

  1. WSRS

    The change between baseline and 2, 8, 16, 24 week WSRS evaluated by the investigator in charge of photographic assessment

    Measured: 2, 8, 16, 24 weeks after the injection

  2. WSRS

    The change between baseline and 2, 8, 16 week WSRS evaluated by the investigator in charge of live assessment

    Measured: 2, 8, 16 weeks after the injection

  3. GAIS

    The rate of subjects whose GAIS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks from the injection

    Measured: 2, 8, 16, 24 weeks after the injection

  4. GAIS

    The rate of subjects whose GAIS, evaluated by the subjects him/herselves, is 1 point or above after 2, 8, 16, 24 weeks from the injection

    Measured: 2, 8, 16, 24 weeks after the injection

  5. WSRS

    The rate of subjects whose change of WSRS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks of the injection

    Measured: 2, 8, 16, 24 weeks after the injection

  6. WSRS

    The rate of subjects whose change of WSRS, evaluated by the investigator in charge of photographic assessment, is 1 pointe or above after 2, 8, 16, 24 weeks of the injection

    Measured: 2, 8, 16, 24 weeks after the injection

  7. Number of adverse events in subjects

    Adverse events occured after informed consent, Adverse drug events, Serious adverse events, lab test, physical examination, vital signs

    Measured: Up to 24 weeks

Timeline

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

  1. First posted25 Apr 2012 (estimated)
  2. Study start9 Feb 2012
  3. Primary completion30 Aug 2012
  4. Study completion30 Oct 2012

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01585220
Sponsor's protocol ID
MT_PRT_NLF01
Status last verified
Mar 2019
First submitted
24 Apr 2012
Last updated
29 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • Pak C, Park J, Hong J, Jeong J, Bang S, Heo CY. A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds. Arch Plast Surg. 2015 Nov;42(6):721-8. doi: 10.5999/aps.2015.42.6.721. Epub 2015 Nov 16.

    PubMed 26618119

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HA filler in people with Nasolabial Fold, run by Medy-Tox 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 6 inclusion and 12 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 29 Mar 2019. 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?

WSRS (time frame: 24 weeks after the injection). 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 NCT01585220, which also lists 1 linked publication.

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 29 Mar 2019.

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