NCT Number: NCT02661737
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Incidence of Device-related Adverse Events
Time frame: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
Sponsors and collaborators
Lead sponsor
LG Life Sciences
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jan 22, 2016
- Registry last updated
- Mar 19, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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