Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 StudyNCT02119793
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 study testing YVOIRE contour in people with Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study, run by LG Life Sciences at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study
- What is being tested?
- YVOIRE contour
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have a history of hypertrophic scars or keloids
- Other criteria as identified in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- YVOIRE contour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YVOIRE contourDevice
YVOIRE contour injection into the anteromedial malar region
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE contour | Experimental | Not described Receives: Device: YVOIRE contour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid Face Aesthetic Scale (MFAS) score
Mean of MFAS score as assessed by the independent blinded rater
Measured: 2, 26, and 52 weeks after repeat treatment
Secondary outcomes (4)
Mid Face Aesthetic Scale (MFAS) score
Changes of MFAS score as assessed by the independent blinded rater
Measured: 2, 26, and 52 weeks after repeat treatment
Mid Face Aesthetic Scale (MFAS) Responder rate
MFAS Responder (at least a one-point improvement on the MFAS) rate as assessed by the independent blinded rater
Measured: 2, 26, and 52 weeks after repeat treatment
Global Aesthetic Improvement Scale (GAIS) score
Mean of GAIS score as assessed by subject
Measured: 2, 26, and 52 weeks after repeat treatment
Global Aesthetic Improvement Scale (GAIS) Responder rate
GAIS Responder (at least a one-point improvement on the GAIS) rate as assessed by subject
Measured: 2, 26, and 52 weeks after repeat treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119793
- Sponsor's protocol ID
- LG-HACL015
- Status last verified
- Nov 2018
- First submitted
- 17 Apr 2014
- Last updated
- 9 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02119793
- Acronym / sponsor ID
- LG-HACL015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YVOIRE contour | Experimental | Device: YVOIRE contour |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Have a history of hypertrophic scars or keloids
- Other criteria as identified in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YVOIRE contourYVOIRE contour injection into the anteromedial malar region | Device | YVOIRE contour |
Primary outcome
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
4 secondary outcomes
Mid Face Aesthetic Scale (MFAS) score
Time frame: 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
Global Aesthetic Improvement Scale (GAIS) score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YVOIRE contour in people with Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study, run by LG Life Sciences at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid Face Aesthetic Scale (MFAS) score (time frame: 2, 26, and 52 weeks after repeat treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.