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

Not Applicable

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

• Registration Number: NCT02119780
• Lead Sponsor: LG Life Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-22
• Study Start: 2014-05
• Primary Completion: 2014-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YVOIRE® contour	YVOIRE® contour	-
Restylane SubQ™	Restylane SubQ™	-

Primary Outcome Measures

Name	Time	Method
Mid Face Aesthetic Scale (MFAS) score	26 weeks after treatment	Mean of MFAS score as assessed by the independent blinded rater

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of