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Completed

NCT Number: NCT02334358

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

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

Completed

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Key information

Conditions

Correction of Nasolabial Folds

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Ninth People's Hospital

Shanghai, China

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
  • Subjects whose WSRS grade is equal or greater than 2
  • Subjects must be willing and able to provide written informed consent
  • Subjects who are scheduled to be treated with YVOIRE classic s for facial tissue augmentation to correct the nasolabial folds

Exclusion criteria

  • Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE classic 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 Classic 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 YVOIRE Classic s Injected Into the Nasolabial Folds

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2015
Registry last updated
Mar 13, 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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