Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s

LG Life Sciences

Status: Completed

Conditions: Correction of Nasolabial Folds

Treatments: Device: YVOIRE volume s

Study type: Observational

Funder types: Industry

Identifiers

NCT02661737

LG-HAOS005

Details and patient eligibility

About

To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.

Enrollment: 503 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

503 participants in 1 patient group

YVOIRE volume s

Description:

Treatment with YVOIRE volume s

Treatment:

Device: YVOIRE volume s