Skip to main content
OpenTrials
Completed

NCT Number: NCT03738007

Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold Injection

This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Temporary Correction of Wrinkles

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: Women in 30~55 years.
  • Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
  • Those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form.

Exclusion criteria

  • Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
  • Those with a history of severe allergy
  • Those with hypertrophic scar or a history of kelloid
  • Patients with an autoimmune disease
  • Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
  • Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
  • Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive materials (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
  • Patients with a malignant tumor
  • Women in pregnancy or lactation
  • Hepatitis carriers or VDRL/HIV positive patients
  • Those with a hypersensitivity to the investigational medical device of this study
  • Other persons including those considered as difficult to perform this study by the principal investigator

Treatment and study plan

HA IDF II

Device

Treatment with HA IDF II (YVOIRE volume)

Perlane

Device

Treatment with Perlane

Primary outcomes

  1. Average of Wrinkle Severity Rating Scale (WSRS) score evaluated by the evaluating investigator at Week 26 (Visit 7) after the final treatment with the investigational medical device.

    Time frame: Week 26 (Visit 7)

    Wrinkle Severity Rating Scale (WSRS)

    • Absent: no visible fold; continuous line
    • Mild: Shallow but visible fold with slight indentation; minor facial feature
    • Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected.
    • Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched
    • Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of HA IDF II Versus Perlane in Nasolabial Fold Injection

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2018
Registry last updated
Nov 26, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.