Status:
COMPLETED
To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume
Lead Sponsor:
LG Chem
Conditions:
Midface Volume Deficit
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
Detailed Description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2022
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04784299
Start Date
March 22 2021
End Date
October 26 2022
Last Update
December 19 2024
Active Locations (1)
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1
LG Chem investigational site 01
Munich, Germany