Jawline Contour DeficitNCT06336759
Safety and Efficacy of Fillers for Contouring the Jawline
A study testing Restylane Defyne and Restylane Lyft in people with Jawline Contour Deficit, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
The study's goal is to assess the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, in order to address concerns regarding contour deficiencies among patients seeking aesthetic treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jawline Contour Deficit
- What is being tested?
- Restylane Defyne and Restylane Lyft
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2021to 10 Nov 2023
- 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
- A score > 1 on the Raspaldo Jawline Scale, as assessed by the treating physician at Baseline. A possible secondary deficit of the chin is allowed.
- Males and females aged > 18 years.
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
- Signed and dated informed consent to participate in the study.
- If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
Who cannot join
- Current pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)].
- Subjects presenting with known allergy to hyaluronic acid fillers or amide local anesthetics.
- Subjects presenting with porphyria.
- Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites.
- Subjects with history of bleeding disorders or subjects taking thrombolytics or anticoagulants.
- Subjects taking inhibitors of platelet aggregation (e.g., Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment.
Show all 19Show fewer
- Subjects using immunosuppressants.
- History of permanent implants in the lower face.
- History of other treatment/procedure that, in the treating investigator's opinion, would interfere with the study injections and/or study assessments or exposes the subject to undue risk by study participation.
- Visible markings that in the treating investigator's opinion, may interfere with results or assessments.
- Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period.
- Heavy smokers, classified as smoking more than 12 cigarettes per day.
- History of severe or multiple allergies manifested by anaphylaxis.
- Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion.
- Previous treatment with neurotoxins in the area under assessment, within 6 months prior to enrolment.
- Previous treatment with soft tissue fillers in the area under assessment, within 12 months prior to enrolment.
- Cancer or precancer in the treatment area (e.g., actinic keratosis).
- Subjects with a tendency to form hypertrophic scars or any other healing disorders.
- Subjects with a mean skin thickness in the treatment areas between 1.29mm and 1.49mm (ie, "normal" thickness), as determined by ultrasound at Baseline, to ensure no overlap between the two strata (ie, thin and thick skin).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Trial Evaluating the Safety and Efficacy of Restylane Lyft and Defyne for Contouring the Jawline
The study's goal is to assess the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, in order to address concerns regarding contour deficiencies among patients seeking aesthetic treatments.
- Conditions
- Jawline Contour Deficit
- Being tested
- Restylane Defyne, Restylane Lyft
- Keywords
- Jawline, Injectables, Hyaluronic Acid, Aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane DefyneDevice
Twenty (20) subjects with thin skin will be recruited and treated with Restylane Defyne.
Restylane LyftDevice
Twenty (20) subjects with thick skin will be recruited and treated with Restylane Lyft.
| Study group | Role | What they receive |
|---|---|---|
| Retylane Defyne | Active comparator | Restylane Defyne is manufactured by Q-Med AB, part of the Galderma Group.
The product is a sterilized 1ml gel syringe contain 20 mg/mL stabilized HA and 3 mg/mL lidocaine hydrochloride in a physiological buffer (phosphate buffered saline pH 7).
The participants deemed to have think skin will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each subject will be determined by the aesthetic judgement of the Treating Investigator. Receives: Device: Restylane Defyne |
| Retylane Lyft | Active comparator | Restylane Defyne is manufactured by Q-Med AB, part of the Galderma Group.
The product is a sterilized 1mL gel syringe contain 20 mg/mL stabilized HA and 3 mg/mL lidocaine hydrochloride in a physiological buffer (phosphate buffered saline pH 7).
The participants deemed to have thick skin will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each subject will be determined by the aesthetic judgement of the Treating Investigator. Receives: Device: Restylane Lyft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
The Global Aesthetic Improvement Scale is a graded Likert scale with assessments ranging form "very much worse" (grade -3) to "very much improved" (grade 3).
Measured: Baseline to Month 3
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale
The Jawline (Raspaldo 2008) Scale is a 5 point Likert scale ranging from "severe depression or atrophy" (grade 4) to "normal" (grade 1) used by the blinded evaluator to assess the jawline
Measured: Baseline to Month 3
Secondary outcomes (2)
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
The Global Aesthetic Improvement Scale is a graded Likert scale with assessments ranging form "very much worse" (grade -3) to "very much improved" (grade 3).
Measured: Baseline to Month 6
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale
The Jawline (Raspaldo 2008) Scale is a 5 point Likert scale ranging from "severe depression or atrophy" (grade 4) to "normal" (grade 1) used by the blinded evaluator to assess the jawline
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start11 Nov 2021
- Primary completion14 Dec 2022
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jawline Contour DeficitStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, MD, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336759
- Sponsor's protocol ID
- 2021-10-GAL-JWL
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 23 May 2024
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial Evaluating the Safety and Efficacy of Restylane Lyft and Defyne for Contouring the Jawline
- ClinicalTrials.gov ID
- NCT06336759
- Acronym / sponsor ID
- 2021-10-GAL-JWL
- Conditions
- Jawline Contour Deficit
- Keywords
- Jawline, Injectables, Hyaluronic Acid, Aesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 29 Mar 2024 (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 study's goal is to assess the safety and efficacy of two hyaluronic acid products, Restylane Lyft and Defyne, for contouring the jawline and chin, in order to address concerns regarding contour deficiencies among patients seeking aesthetic treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retylane Defyne | Active comparator | Device: Restylane DefyneRestylane Defyne is manufactured by Q-Med AB, part of the Galderma Group. The product is a sterilized 1ml gel syringe contain 20 mg/mL stabilized HA and 3 mg/mL lidocaine hydrochloride in a physiological buffer (phosphate buffered saline pH 7). The participants deemed to have think skin will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each subject will be determined by the aesthetic judgement of the Treating Investigator. |
| Retylane Lyft | Active comparator | Device: Restylane LyftRestylane Defyne is manufactured by Q-Med AB, part of the Galderma Group. The product is a sterilized 1mL gel syringe contain 20 mg/mL stabilized HA and 3 mg/mL lidocaine hydrochloride in a physiological buffer (phosphate buffered saline pH 7). The participants deemed to have thick skin will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each subject will be determined by the aesthetic judgement of the Treating Investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A score > 1 on the Raspaldo Jawline Scale, as assessed by the treating physician at Baseline. A possible secondary deficit of the chin is allowed.
- Males and females aged > 18 years.
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
- Signed and dated informed consent to participate in the study.
- If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
Key exclusion criteria (19 listed)
- Current pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)].
- Subjects presenting with known allergy to hyaluronic acid fillers or amide local anesthetics.
- Subjects presenting with porphyria.
- Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment sites.
- Subjects with history of bleeding disorders or subjects taking thrombolytics or anticoagulants.
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 DefyneTwenty (20) subjects with thin skin will be recruited and treated with Restylane Defyne. | Device | Retylane Defyne |
| Restylane LyftTwenty (20) subjects with thick skin will be recruited and treated with Restylane Lyft. | Device | Retylane Lyft |
Primary outcome
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
Time frame: Baseline to Month 3
The Global Aesthetic Improvement Scale is a graded Likert scale with assessments ranging form "very much worse" (grade -3) to "very much improved" (grade 3).
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo (2008) Jawline Scale
Time frame: Baseline to Month 3
The Jawline (Raspaldo 2008) Scale is a 5 point Likert scale ranging from "severe depression or atrophy" (grade 4) to "normal" (grade 1) used by the blinded evaluator to assess the jawline
2 secondary outcomes
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS)
Time frame: Baseline to Month 6
Frequency of subjects displaying at least a one grade improvement since Baseline, on the Raspaldo Jawline Scale
Time frame: Baseline to Month 6
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 23 May 2024.
- Individual participant dataSharing planned: No
Related trials for Jawline Contour Deficit
RecruitingPhase 4
Evaluation of Filler Injection for Chin Profile Enhancement
Chin Regression, Chin Asymmetry
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
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.
Andreas Nikolis, MD principal investigator
Erevna Innovations Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Defyne and Restylane Lyft in people with Jawline Contour Deficit, run by Erevna Innovations Inc. at 1 site 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 19 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 23 May 2024. 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 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?
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?
Frequency of subjects having at least "improved" since Baseline, as per the Global Aesthetic Improvement Scale (GAIS) (time frame: Baseline to Month 3). 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 23 May 2024.