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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

503 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Correction of Nasolabial Folds

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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YVOIRE Classic s

Treatment with YVOIRE Classic s

YVOIRE Classic s

Intervention Type DEVICE

Interventions

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YVOIRE Classic s

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes