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.

NCT04738019 | Completed

• 1 other identifier: LG-HAOS007
• Study Type: observational
• Target: 1,022
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Condition

Outcome Measures

Primary Outcomes (2)

• Delayed-onset nodule.

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

  1 year.

• Other adverse events.

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

  1 year.

Interventions

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any healthy male and female whose filler injection on facial area is already planned for volume enhancement and anti-wrinkle treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Dong Yeop Shin

Seoul, Gangseo-gu, South Korea

Location

Related Publications (1)

• Park SJ, Yoo KH. One-Year Safety Evaluation of New Hyaluronic Acid Fillers (YYS Series): A Prospective, Multicenter, Observational Study. Dermatol Surg. 2024 Aug 1;50(8):731-738. doi: 10.1097/DSS.0000000000004190. Epub 2024 May 2.

  PMID: 38595129 DERIVED

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: June 18, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data is expected to be available during 2022.

Locations

KR (1)