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

A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s Injected Into the Nasolabial Folds

To evaluate long-term safety of YVOIRE classic 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 Classic s

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

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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
2. Subjects whose WSRS grade is equal or greater than 2
3. Subjects must be willing and able to provide written informed consent
4. Subjects who are scheduled to be treated with YVOIRE classic s for facial tissue augmentation to correct the nasolabial folds

Exclusion Criteria:

1. Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE classic 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?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
YVOIRE Classic s; Treatment with YVOIRE Classic s	Device: YVOIRE Classic 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
• Investigators: Principal Investigator: Q Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 4, 2015
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 8, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: LG-HAOS004