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

Correction of Nasolabial Folds Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661737
• Other study ID #: LG-HAOS005
• Status: Completed
• Start date: May 2015
• Est. completion date: September 2017

Study information

• Verified date: November 2018
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: September 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Correction of Nasolabial Folds

Intervention

Device:
• YVOIRE volume s

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Device-related Adverse Events		Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years