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Completed

NCT Number: NCT04437745

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

Completed

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Key information

Conditions

Volume Defects in the Mid-face

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female adults 18 to 65 years of age (inclusive)
  • 3 (moderate) or 4 (severe) on MFVDA-SRS
  • sign the written informed consent form

Exclusion criteria

  • have streptococcal disease or bleeding disorder
  • have an active or infective skin disease, scars, or tumor on mid-face
  • have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
  • have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
  • have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
  • have a medical history of hypertrophic cicatrix or keloid
  • have radiation therapy experience on mid-face
  • have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein

Treatment and study plan

YVOIRE Y-Solution 720

Device

Hyaluronic acid dermal filler

Primary outcomes

  1. Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate

    Time frame: 26 weeks from baseline

    the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.)

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 18, 2020
Registry last updated
Feb 9, 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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