NCT02119780

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

April 17, 2014

Last Update Submit

October 1, 2015

Conditions

Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region

Outcome Measures

Primary Outcomes (1)

  • Mid Face Aesthetic Scale (MFAS) score

    Mean of MFAS score as assessed by the independent blinded rater

    26 weeks after treatment

Secondary Outcomes (5)

  • Mid Face Aesthetic Scale (MFAS) score

    2, 14, and 52 weeks after treatment

  • Mid Face Aesthetic Scale (MFAS) score

    2, 14, 26, and 52 weeks after treatment

  • Mid Face Aesthetic Scale (MFAS) Responder rate

    2, 14, 26, and 52 weeks after treatment

  • Global Aesthetic Improvement Scale (GAIS) score

    2, 14, 26, and 52 weeks after treatment

  • Global Aesthetic Improvement Scale (GAIS) Responder rate

    2, 14, 26, and 52 weeks after treatment

Study Arms (2)

YVOIRE® contour

EXPERIMENTAL
Device: YVOIRE® contour

Restylane SubQ™

ACTIVE COMPARATOR
Device: Restylane SubQ™

Interventions

YVOIRE® contourDEVICE

YVOIRE® contour injection into the anteromedial malar region

YVOIRE® contour
Restylane SubQ™DEVICE

Restylane SubQ™ injection into the anteromedial malar region

Restylane SubQ™

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Males or females who are surgically sterile
  • Post-menopausal females who are above 45 years of age and 2 years after the last menstruation
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 22, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Last Updated

October 5, 2015

Record last verified: 2015-10

Locations

KR(1)