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

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

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

Study Overview

• Status: Completed
• Conditions: Jaw Volume Deficit
• Intervention / Treatment: Device: YVOIRE Y-Solution 720

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • LG Chem investigational site 01
  • Vienna, Austria
    • LG Chem investigational site 02
• Poland
  • Kraków, Poland
    • LG Chem investigational site 03

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Hyaluronic acid dermal filler at Week 0	Device: YVOIRE Y-Solution 720; Hyaluronic acid dermal filler
No Intervention: Control group; Remain untreated until Week 26

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection	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).	26 weeks from baseline

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Principal Investigator, LG Chem investigational site 01

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LG-HACL025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No