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

NCT ID: NCT02661737

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 503 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-09-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

YVOIRE volume s

Treatment with YVOIRE volume s

YVOIRE volume s

Intervention Type: DEVICE

Interventions

YVOIRE volume s

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LG-HAOS005

Identifier Type: -

Identifier Source: org_study_id