Dorsal Hand Volume LossNCT04112017
A Study of YVOIRE Y-Solution 360 for Hand Augmentation to Correct Volume Loss
A study testing YVOIRE Y-Solution 360 in people with Dorsal Hand Volume Loss, run by LG Chem at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dorsal Hand Volume Loss
- What is being tested?
- YVOIRE Y-Solution 360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 27 Sep 2019to 14 Oct 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 Years and older
- Hand Volume Rating Scale (HVRS) of grade 2 or 3 with both hands
- Participants who are willing to undergo the treatment of dorsal hand to correct volume loss
Who cannot join
- Congenital defect, external injuries, lipodystrophy, unhealed wound, disease related-abnormalities, or tumors on the dorsal hands
- Active inflammation or infection on the dorsal hands
- Received anti-coagulation therapy, anti-platelet therapy, or expected to require repeated treatment within 2 weeks prior to visit 2 (randomization)
- Had locally applied ointments (steroid, retinoid, anti-wrinkle production, tanning, or any other form of irritating product) or expected to require repeated treatment within 4 weeks prior to visit 2 (randomization)
- Received immuno-suppressive medication including systemic glucocorticoids or expected to require repeated treatment within 8 weeks prior to visit 2 (randomization)
- Received NSAIDs, Vitamin E, or expected to require repeated treatment within 1 week prior to visit 2 (randomization)
- Had dermal filler injections (HA, CaHA, silicon, PAAG, PMMA etc.), Botulinum toxin therapy, adipose tissue transplantation, or esthetic surgery within 12 months prior to visit 2 (randomization)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Soonchunhyang University
Bucheon-si, Gyeonggi-do
Eulji Hospital
Seoul
About this study
Official title: A Multicenter, Randomized, No-treatment Controlled, Parallel, Evaluator-blind, Medical Device Pivotal Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 Injected Into Dorsal Hand for Hand Augmentation to Correct Volume Loss
The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss.
- Conditions
- Dorsal Hand Volume Loss
- Being tested
- YVOIRE Y-Solution 360
- Keywords
- Hyalunic acid, Filler, Dorsal hand, Medical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YVOIRE Y-Solution 360Device
Hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE Y-Solution 360 | Experimental | Maximum 5 ml including touch-up Receives: Device: YVOIRE Y-Solution 360 |
| No-treatment | No intervention | No-treatment. At 12 weeks after the assessment, treatment maximum 5 ml including touch-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded
5-grade photonumeric hand grading scale (grade 0 - grade 4)
Measured: 12 weeks after treatment
Secondary outcomes (5)
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator
5-grade photonumeric hand grading scale (grade 0 - grade 4)
Measured: Up to 52 weeks after treatment
≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject
5-point scale rating global aesthetic improvement in appearance (score -1 - score 3)
Measured: Up to 52 weeks after treatment
Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator
5-grade photonumeric hand grading scale (grade 0 - grade 4)
Measured: Up to 52 weeks after treatment
Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject
5-point scale rating global aesthetic improvement in appearance (score -1 - score 3)
Measured: Up to 52 weeks after treatment
Safety profile as assessed by incidence of adverse events
Measured: Up to 52 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start27 Sep 2019
- Primary completion14 Oct 2020
- Study completion14 Oct 2020
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dorsal Hand Volume LossStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112017
- Sponsor's protocol ID
- LG-HACL019
- Status last verified
- Jan 2021
- First submitted
- 27 Sep 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, No-treatment Controlled, Parallel, Evaluator-blind, Medical Device Pivotal Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 Injected Into Dorsal Hand for Hand Augmentation to Correct Volume Loss
- ClinicalTrials.gov ID
- NCT04112017
- Acronym / sponsor ID
- LG-HACL019
- Conditions
- Dorsal Hand Volume Loss
- Keywords
- Hyalunic acid, Filler, Dorsal hand, Medical device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 116 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 2 Oct 2019 (actual)
- 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.
The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YVOIRE Y-Solution 360 | Experimental | Device: YVOIRE Y-Solution 360Maximum 5 ml including touch-up |
| No-treatment | No intervention | –No-treatment. At 12 weeks after the assessment, treatment maximum 5 ml including touch-up |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 Years and older
- Hand Volume Rating Scale (HVRS) of grade 2 or 3 with both hands
- Participants who are willing to undergo the treatment of dorsal hand to correct volume loss
Key exclusion criteria (7 listed)
- Congenital defect, external injuries, lipodystrophy, unhealed wound, disease related-abnormalities, or tumors on the dorsal hands
- Active inflammation or infection on the dorsal hands
- Received anti-coagulation therapy, anti-platelet therapy, or expected to require repeated treatment within 2 weeks prior to visit 2 (randomization)
- Had locally applied ointments (steroid, retinoid, anti-wrinkle production, tanning, or any other form of irritating product) or expected to require repeated treatment within 4 weeks prior to visit 2 (randomization)
- Received immuno-suppressive medication including systemic glucocorticoids or expected to require repeated treatment within 8 weeks prior to visit 2 (randomization)
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 Y-Solution 360Hyaluronic acid | Device | YVOIRE Y-Solution 360 |
Primary outcome
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded
Time frame: 12 weeks after treatment
5-grade photonumeric hand grading scale (grade 0 - grade 4)
5 secondary outcomes
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator
Time frame: Up to 52 weeks after treatment
≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject
Time frame: Up to 52 weeks after treatment
Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator
Time frame: Up to 52 weeks after treatment
Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject
Time frame: Up to 52 weeks after treatment
Safety profile as assessed by incidence of adverse events
Time frame: Up to 52 weeks after treatment
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YVOIRE Y-Solution 360 in people with Dorsal Hand Volume Loss, run by LG Chem at 2 sites 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
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?
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded (time frame: 12 weeks after 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 22 Jan 2021.