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.
Completed
- Conditions
- Healthy Condition
- Registration Number
- NCT04738019
- Lead Sponsor
- LG Chem
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1022
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delayed-onset nodule. 1 year. Incidence of delayed-onset nodule in the facial area Y-Solution 360 or 540 or 720 is injected.
Other adverse events. 1 year. Other adverse events occur in the facial area Y-Solution 360 or 540 or 720 is injected.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dong Yeop Shin
🇰🇷Seoul, Gangseo-gu, Korea, Republic of