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Completed

NCT Number: NCT02661737

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

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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

YVOIRE volume s

Device

Primary outcomes

  1. Incidence of Device-related Adverse Events

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

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 22, 2016
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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