Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region

This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.

Study Overview

• Status: Unknown
• Conditions: Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region
• Intervention / Treatment: Device: YVOIRE® contour; Device: Restylane SubQ™

• Study Type: Interventional
• Enrollment (Anticipated): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be male or female, 20-65 years of age
• Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides
• Desire filler treatment to correct volume loss in the anteromedial malar region
• Accept the obligation not to receive any other mid facial procedures or treatments during the study
• Signed informed consent

• Those who fall under one of the following 3 cases

  1. Males or females who are surgically sterile
  2. Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
  3. Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the last treatment of the investigational device to avoid pregnancy

Exclusion Criteria:

• Have a history of hypertrophic scars or keloids
• Other criteria as identified in the protocol

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: YVOIRE® contour	Device: YVOIRE® contour; YVOIRE® contour injection into the anteromedial malar region
Active Comparator: Restylane SubQ™	Device: Restylane SubQ™; Restylane SubQ™ injection into the anteromedial malar region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mid Face Aesthetic Scale (MFAS) score	Mean of MFAS score as assessed by the independent blinded rater	26 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mid Face Aesthetic Scale (MFAS) score	Mean of MFAS score as assessed by the independent blinded rater	2, 14, and 52 weeks after treatment
Mid Face Aesthetic Scale (MFAS) score	Changes of MFAS score as assessed by the independent blinded rater	2, 14, 26, and 52 weeks after treatment
Mid Face Aesthetic Scale (MFAS) Responder rate	MFAS Responder (at least a one-point improvement on the MFAS) rate as assessed by the independent blinded rater	2, 14, 26, and 52 weeks after treatment
Global Aesthetic Improvement Scale (GAIS) score	Mean of GAIS score as assessed by subject	2, 14, 26, and 52 weeks after treatment
Global Aesthetic Improvement Scale (GAIS) Responder rate	GAIS Responder (at least a one-point improvement on the GAIS) rate as assessed by subject	2, 14, 26, and 52 weeks after treatment

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: April 17, 2014
• First Posted (Estimate): April 22, 2014

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: LG-HACL014