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Completed

NCT Number: NCT04886544

Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LG Chem investigational site 01, Vienna, Austria

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About this study

This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.

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 - 75 years of age (inclusive)
  • 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS)
  • want a filler injection procedure for the replacement of volume loss in the jawlines

Exclusion criteria

  • have an active or infective skin disease
  • have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
  • have a tattoo or excessive facial hair in the evaluation area
  • have received permanent facial implants
  • have undergone semi-permanent filler within 24 months
  • have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months
  • have streptococcal disease
  • have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid
  • have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products
  • have history of bleeding disorder
  • have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion
  • have known malignant tumors or cancerous or precancerous lesion
  • positive pregnancy test indicating pregnancy
  • active COVID-19 infection and suspected COVID-19 infection within the past 14 days

Treatment and study plan

YVOIRE Y-Solution 720

Device

Hyaluronic acid dermal filler

Primary outcomes

  1. The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection

    Time frame: 26 weeks from baseline

    The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection for the test group and at Week 26 for the control group, i.e., the proportion of subjects with ≥1 grade improvement on the JCRS score (both jawlines) rated by independent blinded Evaluators at the site (Evaluating Investigator) at Visit 5, compared to that at Baseline (Visit 1).

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 14, 2021
Registry last updated
May 12, 2023

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.