- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02119793
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
November 7, 2018 updated by: LG Life Sciences
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- 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
Exclusion Criteria:
- Have a history of hypertrophic scars or keloids
- Other criteria as identified in the protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YVOIRE contour
|
YVOIRE contour injection into the anteromedial malar region
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mid Face Aesthetic Scale (MFAS) score
Time Frame: 2, 26, and 52 weeks after repeat treatment
|
Mean of MFAS score as assessed by the independent blinded rater
|
2, 26, and 52 weeks after repeat treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mid Face Aesthetic Scale (MFAS) score
Time Frame: 2, 26, and 52 weeks after repeat treatment
|
Changes of MFAS score as assessed by the independent blinded rater
|
2, 26, and 52 weeks after repeat treatment
|
Mid Face Aesthetic Scale (MFAS) Responder rate
Time Frame: 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
|
2, 26, and 52 weeks after repeat treatment
|
Global Aesthetic Improvement Scale (GAIS) score
Time Frame: 2, 26, and 52 weeks after repeat treatment
|
Mean of GAIS score as assessed by subject
|
2, 26, and 52 weeks after repeat treatment
|
Global Aesthetic Improvement Scale (GAIS) Responder rate
Time Frame: 2, 26, and 52 weeks after repeat treatment
|
GAIS Responder (at least a one-point improvement on the GAIS) rate as assessed by subject
|
2, 26, and 52 weeks after repeat treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
April 17, 2014
First Submitted That Met QC Criteria
April 17, 2014
First Posted (Estimate)
April 22, 2014
Study Record Updates
Last Update Posted (Actual)
November 9, 2018
Last Update Submitted That Met QC Criteria
November 7, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- LG-HACL015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study
-
LG Life SciencesUnknownNormal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar RegionKorea, Republic of
Clinical Trials on YVOIRE contour
-
LG Life SciencesUnknownNormal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar RegionKorea, Republic of
-
LG Life SciencesCompletedCorrection of Nasolabial FoldsChina
-
LG ChemActive, not recruiting
-
LG Life SciencesCompleted
-
LG Life SciencesCompletedCorrection of Nasolabial Folds
-
Syneron MedicalUnknown
-
Ascensia Diabetes CareCompletedDiabetesUnited States
-
University of RochesterNational Institute of Mental Health (NIMH); New York University; Weill Medical...RecruitingSchizophrenia | Schizoaffective DisorderUnited States
-
Ascensia Diabetes CareCompletedDiabetes MellitusUnited States
-
Nova Southeastern UniversityDentsply Sirona Implants and ConsumablesCompleted