Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region
Status
Conditions
Treatments
Details and patient eligibility
About
This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Be male or female, 20-65 years of age
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Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides
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Desire filler treatment to correct volume loss in the anteromedial malar region
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Accept the obligation not to receive any other mid facial procedures or treatments during the study
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Signed informed consent
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Those who fall under one of the following 3 cases
- 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
Exclusion criteria
- Have a history of hypertrophic scars or keloids
- Other criteria as identified in the protocol
Trial design
Primary purpose
Allocation
Interventional model
Masking
83 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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