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.

Healthy Condition Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738019
• Other study ID #: LG-HAOS007
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2023
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1022
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Condition

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Dong Yeop Shin	Seoul	Gangseo-gu

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed-onset nodule.	Incidence of delayed-onset nodule in the facial area Y-Solution 360 or 540 or 720 is injected.	1 year.
Primary	Other adverse events.	Other adverse events occur in the facial area Y-Solution 360 or 540 or 720 is injected.	1 year.