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Completed

NCT Number: NCT04784299

To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume

A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume

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Key information

Conditions

Midface Volume Deficit

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LG Chem investigational site 01

Munich, Germany

About this study

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female aged between 21 to 75 years (inclusive)
  • 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
  • Desire cheek augmentation to correct volume deficit in the midface.
  • Agree to use contraception
  • Sign Informed Consent Form

Exclusion criteria

  • have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
  • have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
  • have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
  • have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
  • have history of bleeding disorder
  • have a tendency to develop hypertrophic scarring or keloid

Treatment and study plan

YVOIRE volume plus

Device

Hyaluronic acid dermal filler

Restylane Lyft with Lidocaine

Device

Hyaluronic acid dermal filler

Primary outcomes

  1. Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine

    Time frame: 24 weeks from baseline

    To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment

  2. Responder rate of YVOIRE volume plus

    Time frame: 24 weeks from baseline

    To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment

Secondary outcomes

  1. Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)

    Time frame: 4, 8, 12, 52 weeks from baseline

    To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS

  2. Responder rate of YVOIRE volume plus

    Time frame: 4, 8, 12, 52 weeks from baseline

    To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment

  3. Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)

    Time frame: 4, 8, 12, 24, 52 weeks from baseline

    o compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS

  4. The mean scores of the GAIS

    Time frame: 4, 8, 12, 24, 52 weeks from baseline

    To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS)

  5. Mean change in mid-face volume

    Time frame: 24 weeks from baseline

    To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Dec 19, 2024

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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