Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study

A Multicenter, Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02119793

Enrollment

Registered

2014-04-22

Start date

2015-05-31

Completion date

2016-08-31

Last updated

2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study

Brief summary

This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of YVOIRE contour injected into the anteromedial malar region in subjects who have completed the LG-HACL014 study.

Interventions

DEVICEYVOIRE contour

YVOIRE contour injection into the anteromedial malar region

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Eligible subjects who have completed the LG-HACL014 study * Have anteromedial malar region volume loss at least a one-point worse on the MFAS compared with 2 weeks after treatment in the LG-HACL014 study * 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 repeat 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

Design outcomes

Primary

Measure	Time frame	Description
Mid Face Aesthetic Scale (MFAS) score	2, 26, and 52 weeks after repeat treatment	Mean of MFAS score as assessed by the independent blinded rater

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026