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
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2014
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedNovember 9, 2018
November 1, 2018
1.3 years
April 17, 2014
November 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Mid Face Aesthetic Scale (MFAS) score
Mean of MFAS score as assessed by the independent blinded rater
2, 26, and 52 weeks after repeat treatment
Secondary Outcomes (4)
Mid Face Aesthetic Scale (MFAS) score
2, 26, and 52 weeks after repeat treatment
Mid Face Aesthetic Scale (MFAS) Responder rate
2, 26, and 52 weeks after repeat treatment
Global Aesthetic Improvement Scale (GAIS) score
2, 26, and 52 weeks after repeat treatment
Global Aesthetic Improvement Scale (GAIS) Responder rate
2, 26, and 52 weeks after repeat treatment
Study Arms (1)
YVOIRE contour
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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 repeat 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
- LG Life Scienceslead
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2014
First Posted
April 22, 2014
Study Start
May 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
November 9, 2018
Record last verified: 2018-11