Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region
NCT ID: NCT02119780
Last Updated: 2015-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
83 participants
INTERVENTIONAL
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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YVOIRE® contour
YVOIRE® contour
YVOIRE® contour injection into the anteromedial malar region
Restylane SubQ™
Restylane SubQ™
Restylane SubQ™ injection into the anteromedial malar region
Interventions
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YVOIRE® contour
YVOIRE® contour injection into the anteromedial malar region
Restylane SubQ™
Restylane SubQ™ injection into the anteromedial malar region
Eligibility Criteria
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Inclusion Criteria
* 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
1. Males or females who are surgically sterile
2. Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
3. 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
Exclusion Criteria
* Other criteria as identified in the protocol
20 Years
65 Years
ALL
Yes
Sponsors
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LG Life Sciences
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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LG-HACL014
Identifier Type: -
Identifier Source: org_study_id
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