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

Midface Volume Deficit Clinical Trial

Official title:

A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft With Lidocaine for Temporary Improvement of Mid-face Volume

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04784299
• Other study ID #: LG-HACL029
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: October 2022

Study information

• Verified date: March 2021
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: October 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male and female aged between 21 to 75 years (inclusive)

• 2 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Midface Volume Deficit

Intervention

Device:
• YVOIRE volume plus
Hyaluronic acid dermal filler
• Restylane Lyft with Lidocaine
Hyaluronic acid dermal filler

Locations

Country	Name	City	State
Germany	LG Chem investigational site 01	Munich

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS	4, 8, 12, 52 weeks from baseline
Secondary	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	4, 8, 12, 52 weeks from baseline
Secondary	Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)	o compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS	4, 8, 12, 24, 52 weeks from baseline
Secondary	The mean scores of the GAIS	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS)	4, 8, 12, 24, 52 weeks from baseline
Secondary	Mean change in mid-face volume	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement	24 weeks from baseline