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.
NCT number | NCT04738019 |
Other study ID # | LG-HAOS007 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 18, 2020 |
Est. completion date | February 28, 2022 |
Verified date | January 2023 |
Source | LG Chem |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Dong Yeop Shin | Seoul | Gangseo-gu |
Lead Sponsor | Collaborator |
---|---|
LG Chem |
Korea, Republic of,
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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