Correction of Nasolabial Folds
Conditions
Brief summary
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.
Interventions
DEVICEYVOIRE volume s
Sponsors
LG Life Sciences
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects whose age is over 18 years old and under 65 years old 2. Subjects whose WSRS grade is equal or greater than 2 3. Subjects must be willing and able to provide written informed consent form 4. Subjects who are scheduled to be treated with YVOIRE volumes for facial tissue augmentation to correct the nasolabial folds
Exclusion criteria
1. Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE volume s 2. Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds 3. Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening 4. Subjects who have received face lifting or plastic surgery on face within 9 months before screening 5. Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening 6. Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites 7. Subjects who tend to have hypertrophic scars 8. Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders. 9. Women in pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Device-related Adverse Events | Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| YVOIRE Volume s YVOIRE volume s
YVOIRE volume s | 469 |
| Total | 469 |
Baseline characteristics
| Characteristic | YVOIRE Volume s |
|---|---|
| Age, Continuous | 40.58 years STANDARD_DEVIATION 9.61 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 469 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 462 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 503 |
| other Total, other adverse events | 115 / 503 |
| serious Total, serious adverse events | 20 / 503 |
Outcome results
Primary
Incidence of Device-related Adverse Events
Time frame: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| YVOIRE Volume s | Incidence of Device-related Adverse Events | 3 Participants |