N/A
N=503
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s
Correction of Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT02661737 ↗Enrolled (actual)
503
Serious AEs
4.0%
Results posted
Mar 2019
Primary outcome: Primary: Incidence of Device-related Adverse Events — 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- YVOIRE volume s (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LG Life Sciences
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Device-related Adverse Events |
3 | — |
Summary
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02661737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.