To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume (NCT04784299) | Clinical Trial Compass
CompletedNot Applicable
To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume
Germany105 participantsStarted 2021-03-22
Plain-language summary
A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
Who can participate
Age range21 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female aged between 21 to 75 years (inclusive)
* 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
* Desire cheek augmentation to correct volume deficit in the midface.
* Agree to use contraception
* Sign Informed Consent Form
Exclusion Criteria:
* have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
* have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
* have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
* have history of bleeding disorder
* have a tendency to develop hypertrophic scarring or keloid
What they're measuring
1
Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine