Lip AugmentationNCT04299295
To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.
A study testing YVOIRE Y-Solution 360 and Juvéderm VOLBELLA in people with Lip Augmentation, run by LG Chem at 1 site in Germany.
Trial summary
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- YVOIRE Y-Solution 360 and Juvéderm VOLBELLA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jun 2020to 1 Mar 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 years or above age.
- 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
- Agree to use proper contraception as guided in the protocol.
- Signed for Informed Consent.
Who cannot join
- have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
- who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
- have undergone oral surgery within 6 weeks
- have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
- have undergone semi-permanent filler in lower face within 24 months
- have undergone temporary dermal filler treatment in the lower face within 12 months
Show all 9Show fewer
- Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months
- Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months
- have used lip plumping products within 10 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area.
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
Read the detailed description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area
- Conditions
- Lip Augmentation
- Being tested
- YVOIRE Y-Solution 360, Juvéderm VOLBELLA
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 dermal filler
Juvéderm VOLBELLADevice
Hyaluronic acid dermal filler
| Study group | Role | What they receive |
|---|---|---|
| YVOIRE Y-Solution 360 | Experimental | Hyaluronic acid dermal filler Receives: Device: YVOIRE Y-Solution 360 |
| Juvéderm VOLBELLA | Active comparator | Hyaluronic acid dermal filler Receives: Device: Juvéderm VOLBELLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.
To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the mean change from baseline to 12 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). LFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Pronounced), and 4 (Very Pronounced).
Measured: 12 weeks from baseline
Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.
To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Lip Fullness Rating Scale (LFRS) from baseline to 12 weeks will be calculated.
Measured: 12 weeks from baseline
Secondary outcomes (5)
Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.
To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS).
Measured: 2, 4, 12, 24 weeks from baseline
Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.
To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the responder rate (defined as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS).
Measured: 2, 4, 12, 24 weeks from baseline
Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.
To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS).
Measured: 2, 4, 12, 24 weeks from baseline
Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.
To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the responder rate (as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS).
Measured: 2, 4, 12, 24 weeks from baseline
Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator.
To measure the satisfaction of YVOIRE Y-Solution 360 the GAIS evaluation will be performed by subject and investigator. GAIS Grade are -2 (Much Worse), -1 (Worse), 0 (No change), 1 (Improved), and 2 (Much improved).
Measured: 2, 4, 12, 24 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start5 Jun 2020
- Primary completion7 Dec 2020
- Study completion1 Mar 2021
Why it stopped: Due to company's internal decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lip AugmentationStudies 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tanja C. Fischer, Principal investigator, Haut-und Lasercentrum Potsdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299295
- Sponsor's protocol ID
- LG-HACL023
- Status last verified
- Jun 2020
- First submitted
- 2 Mar 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area.
- ClinicalTrials.gov ID
- NCT04299295
- Acronym / sponsor ID
- LG-HACL023
- Conditions
- Lip Augmentation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to company's internal decision.
- Enrolment
- 118 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 6 Mar 2020 (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.
A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
Detailed description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area
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 360Hyaluronic acid dermal filler |
| Juvéderm VOLBELLA | Active comparator | Device: Juvéderm VOLBELLAHyaluronic acid dermal filler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 18 years or above age.
- 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
- Agree to use proper contraception as guided in the protocol.
- Signed for Informed Consent.
Key exclusion criteria (9 listed)
- have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
- who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
- have undergone oral surgery within 6 weeks
- have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
- have undergone semi-permanent filler in lower face within 24 months
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 dermal filler | Device | YVOIRE Y-Solution 360 |
| Juvéderm VOLBELLAHyaluronic acid dermal filler | Device | Juvéderm VOLBELLA |
Primary outcome
Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12.
Time frame: 12 weeks from baseline
To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the mean change from baseline to 12 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). LFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Pronounced), and 4 (Very Pronounced).
Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12.
Time frame: 12 weeks from baseline
To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Lip Fullness Rating Scale (LFRS) from baseline to 12 weeks will be calculated.
5 secondary outcomes
Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.
Time frame: 2, 4, 12, 24 weeks from baseline
Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24.
Time frame: 2, 4, 12, 24 weeks from baseline
Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.
Time frame: 2, 4, 12, 24 weeks from baseline
Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24.
Time frame: 2, 4, 12, 24 weeks from baseline
Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator.
Time frame: 2, 4, 12, 24 weeks from baseline
Results and safety
The study was stopped early (reason given: Due to company's internal decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Lip Augmentation
Recruiting
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
Lip Augmentation
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Active, not recruiting
Clinical Investigation on Lips Treated With HA-filler
Aesthetic Correction of the Lips
Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
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.
Tanja C. Fischer principal investigator
Haut-und Lasercentrum Potsdam
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 Y-Solution 360 and Juvéderm VOLBELLA in people with Lip Augmentation, run by LG Chem at 1 site in Germany.
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 4 inclusion and 9 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 14 Oct 2021. 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 Germany. 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: Due to company's internal 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?
Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12. (time frame: 12 weeks from baseline). The study lists 2 primary outcomes in all. 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 14 Oct 2021.