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

NCT02661737 | Completed Results

• 1 other identifier: LG-HAOS005
• Study Type: observational
• Target: 503
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Correction of Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

• Incidence of Device-related Adverse Events

  Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years

Study Arms (1)

YVOIRE volume s

Treatment with YVOIRE volume s

Device: YVOIRE volume s

Interventions

YVOIRE volume s DEVICE

YVOIRE volume s

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject who receive hyaluronic acid filler into the nasolabial folds

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Results Point of Contact

• Title: Study Leader
• Organization: LG Chem

sodam@lgchem.com

82-2-6987-4148

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 22, 2016
• Study Start: May 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2018-11