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

Not Applicable

Completed

• Conditions: Volume Defects in the Mid-face
• Interventions: Device: YVOIRE Y-Solution 720

• Registration Number: NCT04437745
• Lead Sponsor: LG Chem

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Study Start: 2020-11-25
• Primary Completion: 2022-12-13
• Study Completion: 2023-11-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YVOIRE Y-Solution 720	YVOIRE Y-Solution 720	Hyaluronic acid dermal filler

Primary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China