NCT02661737CompletedNot Applicable
A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of Modified Sodium Hyaluronate Gel (YVOIRE Volume s) Injected for Correction of Nasolabial Folds
LG Life Sciences0 sites503 target enrollmentStarted: May 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 503
- Primary Endpoint
- Incidence of Device-related Adverse Events
Study Overview
Brief Summary
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects whose age is over 18 years old and under 65 years old
- •Subjects whose WSRS grade is equal or greater than 2
- •Subjects must be willing and able to provide written informed consent form
- •Subjects who are scheduled to be treated with YVOIRE volumes for facial tissue augmentation to correct the nasolabial folds
Exclusion Criteria
- •Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE volume s
- •Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds
- •Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening
- •Subjects who have received face lifting or plastic surgery on face within 9 months before screening
- •Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening
- •Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites
- •Subjects who tend to have hypertrophic scars
- •Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders.
- •Women in pregnancy or lactation
Outcomes
Primary Outcomes
Incidence of Device-related Adverse Events
Time Frame: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
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