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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1022 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-18

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Condition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Medical examination or treatment.

Medical examination or treatment when delayed on-set nodule or other side effects occur due to Y-Solution filler injection.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes