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

Not Applicable

Completed

• Conditions: Jaw Volume Deficit
• Interventions: Device: YVOIRE Y-Solution 720

• Registration Number: NCT04886544
• Lead Sponsor: LG Chem

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-14
• Study Start: 2021-06-25
• Primary Completion: 2022-05-11
• Study Completion: 2023-01-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	YVOIRE Y-Solution 720	Hyaluronic acid dermal filler at Week 0

Primary Outcome Measures

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

Trial Locations

Locations (3)

LG Chem investigational site 03; 🇵🇱 Kraków, Poland

LG Chem investigational site 01; 🇦🇹 Vienna, Austria

LG Chem investigational site 02; 🇦🇹 Vienna, Austria