Status:
COMPLETED
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
Lead Sponsor:
LG Chem
Conditions:
Volume Defects in the Mid-face
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
Eligibility Criteria
Inclusion
- Male or female adults 18 to 65 years of age (inclusive)
- 3 (moderate) or 4 (severe) on MFVDA-SRS
- sign the written informed consent form
Exclusion
- have streptococcal disease or bleeding disorder
- have an active or infective skin disease, scars, or tumor on mid-face
- have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
- have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
- have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
- have a medical history of hypertrophic cicatrix or keloid
- have radiation therapy experience on mid-face
- have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2023
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04437745
Start Date
November 25 2020
End Date
November 8 2023
Last Update
February 9 2024
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China