Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar RegionNCT02119780
Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region
A study testing YVOIRE® contour and Restylane SubQ™ in people with Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region, run by LG Life Sciences at 1 site in South Korea.
Trial summary
This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region
- What is being tested?
- YVOIRE® contour and Restylane SubQ™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Oct 2014
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be male or female, 20-65 years of age
- Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides
- Desire filler treatment to correct volume loss in the anteromedial malar region
- Accept the obligation not to receive any other mid facial procedures or treatments during the study
- Signed informed consent
- Those who fall under one of the following 3 cases
Show all 9Show fewer
- Males or females who are surgically sterile
- Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
- Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the last treatment of the investigational device to avoid pregnancy
Who cannot join
- Have a history of hypertrophic scars or keloids
- Other criteria as identified in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.
- Being tested
- YVOIRE® contour, Restylane SubQ™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YVOIRE® contourDevice
YVOIRE® contour injection into the anteromedial malar region
Restylane SubQ™Device
Restylane SubQ™ injection into the anteromedial malar region
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE® contour | Experimental | Not described Receives: Device: YVOIRE® contour |
| Restylane SubQ™ | Active comparator | Not described Receives: Device: Restylane SubQ™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid Face Aesthetic Scale (MFAS) score
Mean of MFAS score as assessed by the independent blinded rater
Measured: 26 weeks after treatment
Secondary outcomes (5)
Mid Face Aesthetic Scale (MFAS) score
Mean of MFAS score as assessed by the independent blinded rater
Measured: 2, 14, and 52 weeks after treatment
Mid Face Aesthetic Scale (MFAS) score
Changes of MFAS score as assessed by the independent blinded rater
Measured: 2, 14, 26, and 52 weeks after treatment
Mid Face Aesthetic Scale (MFAS) Responder rate
MFAS Responder (at least a one-point improvement on the MFAS) rate as assessed by the independent blinded rater
Measured: 2, 14, 26, and 52 weeks after treatment
Global Aesthetic Improvement Scale (GAIS) score
Mean of GAIS score as assessed by subject
Measured: 2, 14, 26, and 52 weeks after treatment
Global Aesthetic Improvement Scale (GAIS) Responder rate
GAIS Responder (at least a one-point improvement on the GAIS) rate as assessed by subject
Measured: 2, 14, 26, and 52 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar RegionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119780
- Sponsor's protocol ID
- LG-HACL014
- Status last verified
- Oct 2015
- First submitted
- 17 Apr 2014
- Last updated
- 5 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region
- ClinicalTrials.gov ID
- NCT02119780
- Acronym / sponsor ID
- LG-HACL014
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- First posted
- 22 Apr 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 purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YVOIRE® contour | Experimental | Device: YVOIRE® contour |
| Restylane SubQ™ | Active comparator | Device: Restylane SubQ™ |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be male or female, 20-65 years of age
- Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides
- Desire filler treatment to correct volume loss in the anteromedial malar region
- Accept the obligation not to receive any other mid facial procedures or treatments during the study
- Signed informed consent
Key exclusion criteria (2 listed)
- Have a history of hypertrophic scars or keloids
- Other criteria as identified in the protocol
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 |
|---|---|---|
| YVOIRE® contourYVOIRE® contour injection into the anteromedial malar region | Device | YVOIRE® contour |
| Restylane SubQ™Restylane SubQ™ injection into the anteromedial malar region | Device | Restylane SubQ™ |
Primary outcome
Mid Face Aesthetic Scale (MFAS) score
Time frame: 26 weeks after treatment
Mean of MFAS score as assessed by the independent blinded rater
5 secondary outcomes
Mid Face Aesthetic Scale (MFAS) score
Time frame: 2, 14, and 52 weeks after treatment
Mid Face Aesthetic Scale (MFAS) score
Time frame: 2, 14, 26, and 52 weeks after treatment
Mid Face Aesthetic Scale (MFAS) Responder rate
Time frame: 2, 14, 26, and 52 weeks after treatment
Global Aesthetic Improvement Scale (GAIS) score
Time frame: 2, 14, 26, and 52 weeks after treatment
Global Aesthetic Improvement Scale (GAIS) Responder rate
Time frame: 2, 14, 26, and 52 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YVOIRE® contour and Restylane SubQ™ in people with Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region, run by LG Life Sciences at 1 site 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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
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?
Mid Face Aesthetic Scale (MFAS) score (time frame: 26 weeks after treatment). 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 5 Oct 2015.