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

Completed

• Conditions: Correction of Nasolabial Folds
• Interventions: Device: YVOIRE volume s

• Registration Number: NCT02661737
• Lead Sponsor: LG Life Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-22
• Primary Completion: 2017-04
• Study Completion: 2017-09
• Status Verified: 2018-11
• Results First Submitted: 2018-11-27
• Results First Submitted QC: 2018-11-27
• Last Update Submitted: 2018-11-27
• Results First Posted: 2019-03-19
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
YVOIRE volume s	YVOIRE volume s	Treatment with YVOIRE volume s

Primary Outcome Measures

Name	Time	Method
Incidence of Device-related Adverse Events	Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years