Healthy Condition
Conditions
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.
Interventions
DIAGNOSTIC_TESTMedical examination or treatment.
Medical examination or treatment when delayed on-set nodule or other side effects occur due to Y-Solution filler injection.
Sponsors
LG Chem
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Other adverse events. | 1 year. | Other adverse events occur in the facial area Y-Solution 360 or 540 or 720 is injected. |
| Delayed-onset nodule. | 1 year. | Incidence of delayed-onset nodule in the facial area Y-Solution 360 or 540 or 720 is injected. |
Countries
South Korea
Outcome results
None listed