Status:
COMPLETED
A Multicenter, Prospective Observational Study to Evaluate the Incidence of Delayed-onset Nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 Injected Into the Facial Skin Layer.
Lead Sponsor:
LG Chem
Conditions:
Healthy Condition
Eligibility:
All Genders
19+ years
Brief Summary
This is an observational study to evaluate the incidence of delayed-onset nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 injected into the facial skin layer.
Eligibility Criteria
Inclusion
- Planned for YVOIRE Y-Solution 360 or 540 or 720 filler injection in facial area (except middle of the forehead, lips) for the volume enhancement or anti-wrinkle treatment.
- Male and female of 19 years or above age.
- Informed consent to participate in the study.
- Able to participate throughout the study period.
Exclusion
- Prohibited in the Product Label.
- Have active or infectious skin disease in injection area.
- Autoimmune disease or HIV infected patient.
- Received immunosuppressive therapy within 2 weeks.
- Previously experienced Delayed-onset nodule after filler injection in facial area.
- Previously experienced Hypertrophic scar or Keloid.
- Have participated in an interventional clinical investigation within 30 days or plan to participate one during the study period.
- Ineligible for this clinical investigation as per Investigator's discretion.
Key Trial Info
Start Date :
June 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
1022 Patients enrolled
Trial Details
Trial ID
NCT04738019
Start Date
June 18 2020
End Date
February 28 2022
Last Update
January 12 2023
Active Locations (1)
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1
Dong Yeop Shin
Seoul, Gangseo-gu, South Korea