Jawline DefinitionNCT05622812
Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
A study testing Restylane Lyft Lidocaine in people with Jawline Definition, run by Galderma R&D at 9 sites in Canada.
Trial summary
This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jawline Definition
- What is being tested?
- Restylane Lyft Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 9 sitesCanada
- Study dates
- 16 Feb 2023to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and female adults willing to comply with the requirements of the study and providing a signed written informed consent
- Consent the use of facial images for marketing purposes and educational material
- Subject with moderate to very severe (Grade 2 to 4) on the GJS
- Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
- Female of childbearing potential with a negative urine pregnancy test before treatment
Who cannot join
- Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
- Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
- Subject with bleeding disorders or taking thrombolytics or anticoagulants
- Prior surgical procedure in the treatment area
- History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
- Presence of any disease or lesions near or on the area to be treated
Show all 10Show fewer
- Presence of any condition, in the opinion of the Treating Investigator, makes the subject unable to complete the study per protocol
- Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period
- Study site personnel, close relatives of the study site personnel, employees, or close relatives of employees at the Sponsor Company
- Participation in any other interventional clinical study within 30 days before treatment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Galderma Research Site
Burlington, Ontario, L7N3N2
Galderma Research Site
London, Ontario, N6H5L5
Galderma Research Site
Oakville, Ontario, L6J7W5
Galderma Research Site
Toronto, Ontario, M5R3N8
Galderma Research Site
Vancouver, British Columbia, V5Z4E1
Galderma Research Site
Vancouver, British Columbia, V6H4E1
Galderma Research Site
Westmount, Quebec, H3Z1C3
Galderma Research Site
Windsor, Ontario, N8W5L7
Galderma Research Site
Woodbridge, Ontario, L4L8E2
About this study
Official title: A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
This study is designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition
Read the detailed description
A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada
- Conditions
- Jawline Definition
- Being tested
- Restylane Lyft Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane Lyft LidocaineDevice
Treatment for Jawline definition
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Initial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment Receives: Device: Restylane Lyft Lidocaine |
| No-treatment control group | No intervention | Optional treatment will be administered at 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Measured: Baseline, Month 3
Secondary outcomes (3)
Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator
The GJS is a validated 5-point scale for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. Here, higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Measured: Baseline, Months 6, 9 and 12
Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the Treating Investigator was reported here.
Measured: Baseline, Months 3, 6, 9 and 12
Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the GAIS as assessed live by the participant was reported here.
Measured: Baseline, Months 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start16 Feb 2023
- Primary completion16 Oct 2023
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Jawline DefinitionStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Model description
- A prospective, randomized, evaluator-blinded, no treatment controlled, parallel group, multicenter phase IV study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for jawline definition. A parallel study: two or more groups of participants receive different interventions. Trial participants are assigned to one of the treatment arms at the beginning of the trial and remain in that trial arm throughout the length of the trial. A randomized group is usually assigned.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622812
- Sponsor's protocol ID
- 05DF2209
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2022
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
- ClinicalTrials.gov ID
- NCT05622812
- Acronym / sponsor ID
- 05DF2209
- Conditions
- Jawline Definition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Posted 7 Mar 2025
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 designed to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition
Detailed description
A randomized, evaluator-blinded, parallel group, no treatment controlled, multicenter study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for Jawline definition in Canada
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized, evaluator-blinded, no treatment controlled, parallel group, multicenter phase IV study to evaluate effectiveness and safety of Restylane Lyft Lidocaine for jawline definition. A parallel study: two or more groups of participants receive different interventions. Trial participants are assigned to one of the treatment arms at the beginning of the trial and remain in that trial arm throughout the length of the trial. A randomized group is usually assigned.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Restylane Lyft LidocaineInitial Restylane Lyft Lidocaine injection and one optional touch-up treatment at 1 month after treatment |
| No-treatment control group | No intervention | –Optional treatment will be administered at 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adults willing to comply with the requirements of the study and providing a signed written informed consent
- Consent the use of facial images for marketing purposes and educational material
- Subject with moderate to very severe (Grade 2 to 4) on the GJS
- Subject is willing to abstain from any other facial, submental, and/or neck aesthetic procedure(s) or implant
- Female of childbearing potential with a negative urine pregnancy test before treatment
Key exclusion criteria (10 listed)
- Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid (HA) filler, lidocaine or other amide-type local anesthetics
- Subjects presenting with known/previous allergy or hypersensitivity to streptococcal proteins
- Subject with bleeding disorders or taking thrombolytics or anticoagulants
- Prior surgical procedure in the treatment area
- History of other facial treatment/procedure in the previous 6 months HA in or near the intended treatment site
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 |
|---|---|---|
| Restylane Lyft LidocaineTreatment for Jawline definition | Device | Treatment group |
Primary outcome
Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator
Time frame: Baseline, Month 3
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
3 secondary outcomes
Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded Evaluator
Time frame: Baseline, Months 6, 9 and 12
Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12
Time frame: Baseline, Months 3, 6, 9 and 12
Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12
Time frame: Baseline, Months 3, 6, 9 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Study Director study director
Galderma R&D
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Lyft Lidocaine in people with Jawline Definition, run by Galderma R&D at 9 sites in Canada.
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 5 inclusion and 10 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 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded Evaluator (time frame: Baseline, Month 3). 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 7 Mar 2025.