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OpenTrials
Completed

NCT Number: NCT04738019

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.

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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Key information

Conditions

Healthy Condition

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dong Yeop Shin

Seoul, Gangseo-gu, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medical examination or treatment.

Diagnostic Test

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

Primary outcomes

  1. Delayed-onset nodule.

    Time frame: 1 year.

    Incidence of delayed-onset nodule in the facial area Y-Solution 360 or 540 or 720 is injected.

  2. Other adverse events.

    Time frame: 1 year.

    Other adverse events occur in the facial area Y-Solution 360 or 540 or 720 is injected.

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2021
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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