To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume

NCT04784299 | Completed

• 1 other identifier: LG-HACL029
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume

Conditions

Midface Volume Deficit

Outcome Measures

Primary Outcomes (2)

• Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine

  To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment

  24 weeks from baseline

• Responder rate of YVOIRE volume plus

  To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment

  24 weeks from baseline

Secondary Outcomes (5)

• Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)

  4, 8, 12, 52 weeks from baseline

• Responder rate of YVOIRE volume plus

  4, 8, 12, 52 weeks from baseline

• Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)

  4, 8, 12, 24, 52 weeks from baseline

• The mean scores of the GAIS

  4, 8, 12, 24, 52 weeks from baseline

• Mean change in mid-face volume

  24 weeks from baseline

Study Arms (2)

YVOIRE volume plus

EXPERIMENTAL

Hyaluronic acid dermal filler

Device: YVOIRE volume plus

Restylane Lyft with Lidocaine

ACTIVE COMPARATOR

Hyaluronic acid dermal filler

Device: Restylane Lyft with Lidocaine

Interventions

YVOIRE volume plus DEVICE

Hyaluronic acid dermal filler

YVOIRE volume plus

Restylane Lyft with Lidocaine DEVICE

Hyaluronic acid dermal filler

Restylane Lyft with Lidocaine

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female aged between 21 to 75 years (inclusive)
• or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
• Desire cheek augmentation to correct volume deficit in the midface.
• Agree to use contraception
• Sign Informed Consent Form

You may not qualify if:

• have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
• have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
• have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
• have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
• have history of bleeding disorder
• have a tendency to develop hypertrophic scarring or keloid

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

LG Chem investigational site 01

Munich, Germany

Location

Study Officials

• Investigator

  LG Chem Investigational site 01

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: March 22, 2021
• Primary Completion: April 11, 2022
• Study Completion: October 26, 2022
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)