Overview

This trial is active, not recruiting.

Condition normal, healthy adults with moderate, severe, or very severe volume loss of anteromedial malar region
Treatments yvoire® contour, restylane subq™
Sponsor LG Life Sciences
Start date May 2014
End date October 2014
Trial size 83 participants
Trial identifier NCT02119780, LG-HACL014

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
yvoire® contour
YVOIRE® contour injection into the anteromedial malar region
(Active Comparator)
restylane subq™
Restylane SubQ™ injection into the anteromedial malar region

Primary Outcomes

Measure
Mid Face Aesthetic Scale (MFAS) score
time frame: 26 weeks after treatment

Secondary Outcomes

Measure
Mid Face Aesthetic Scale (MFAS) score
time frame: 2, 14, and 52 weeks after treatment
Mid Face Aesthetic Scale (MFAS) score
time frame: 2, 14, 26, and 52 weeks after treatment
Mid Face Aesthetic Scale (MFAS) Responder rate
time frame: 2, 14, 26, and 52 weeks after treatment
Global Aesthetic Improvement Scale (GAIS) score
time frame: 2, 14, 26, and 52 weeks after treatment
Global Aesthetic Improvement Scale (GAIS) Responder rate
time frame: 2, 14, 26, and 52 weeks after treatment

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by LG Life Sciences.