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

LG Life Sciences

Status

Completed

Conditions

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

Treatments

Device: YVOIRE contour

Study type

Interventional

Funder types

Industry

Identifiers

NCT02119793

LG-HACL015

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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