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

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

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

Study Overview

• Status: Completed
• Conditions: Correction of Nasolabial Folds
• Intervention / Treatment: Device: YVOIRE volume s

• Study Type: Observational
• Enrollment (Actual): 503

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject who receive hyaluronic acid filler into the nasolabial folds

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
YVOIRE volume s; Treatment with YVOIRE volume s	Device: YVOIRE volume s

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: LG-HAOS005