ContourPhase 4JAWLINENCT03425253
Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
A Phase 4 study testing BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine in people with Contour, run by Allergan at 3 sites in Australia.
Trial summary
This study has been designed to evaluate the safety and effectiveness of sequential treatment with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Contour
- What is being tested?
- BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesAustralia
- Study dates
- 2 Feb 2018to 5 Dec 2019
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 2 or above on Allergan Loss of Jawline Definition Scale (ALJDS)
- Grade 2 or 3 on reported Clinician-Rated Submental Fat Rating Scale (CR-SMFRS)
- Stable body weight for at least 26 weeks
- Accept the obligation to forego any treatment or behavior (e.g., unshaven facial hair; significant changes to dietary or exercise habits) during the participants participation in the study that may affect the assessments of the submental area
Who cannot join
- Grade 4 on Submental Skin Laxity Grade (SMSLG)
- Grade 4 on Allergan Jowl Fat Rating Scale (AJFRS)
- Body mass index (BMI) >35 kg/m^2
- History of, or current symptoms of dysphagia
- History of temporary, semi-permanent or permanent facial or neck dermal filler injections below the medial canthi at any time prior to treatment, or within 52 weeks before Screening for treatment above the medial canthi
- History of facial and/or neck plastic surgery, tissue grafting or permanent facial implants anywhere in the face or neck
Show all 17Show fewer
- History of any intervention (e.g., liposuction, surgery, or lipolytic agents) to treat submental fat (SMF)
- Evidence of any cause of enlargement in the submental area other than localized SMF
- History of mesotherapy or ablative procedures to the face and/or neck 52 weeks before Screening
- History of skin resurfacing in the neck or submental area within 26 weeks before Screening
- Treatment with botulinum toxin injections in the neck or submental area within 26 weeks before Screening
- Participants on prescription topical retinoid therapy and/or topical hormone cream applied to the face, who have not been on a consistent dose regimen for at least 26 weeks before Screening and who are unable to maintain regimen for the study
- Systemic retinoid therapy within 52 weeks before Screening
- Current use of oral corticosteroids
- Is on a regimen of anticoagulation therapy (eg, warfarin, clopidogrel)
- Has current injection site inflammatory or infectious processes, abscess, an unhealed wound, or a known cancerous or precancerous lesion in chin, masseter, or submental region
- Planned oral surgery or other dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 2 weeks prior to and after VOLUMA™ treatment
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Darlinghurst Dermatology
Darlinghurst, New South Wales, 2010
Living Art
East Melbourne, Victoria, 3002
Dermatology Institute of Victoria
South Yarra, Victoria, 3141
About this study
Official title: A Prospective, Open-label Study to Evaluate Sequential Treatment With BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
This study has been designed to evaluate the safety and effectiveness of sequential treatment with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline.
Read the detailed description
Participants may be treated with up to 6 treatments with Belkyra, followed by treatment with Voluma. Participants will have opportunity to participation in a skin biopsy sub-study.
- Conditions
- Contour
- Being tested
- BELKYRA®, Juvéderm® VOLUMA™ with Lidocaine
- Keywords
- Lower Face Contouring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BELKYRA®Drug
BELKYRA® was injected into preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart).
Juvéderm® VOLUMA™ with LidocaineDevice
Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.
| Study group | Role | What they receive |
|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine | Experimental | BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable. Receives: Drug: BELKYRA®; Device: Juvéderm® VOLUMA™ with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator
The ALJDS was an investigator assessment of loss of jawline definition measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. Data is reported for both sides of the face, right side of the face and left side of the face.
Measured: Baseline (Day 0) to Week 58
Secondary outcomes (8)
Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
The ALJDS was an investigator and independent reviewer assessment of jawline contour measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. A negative change from baseline indicated improvement. The data is reported for both sides of the face, right side of the face and left side of the face.
Measured: Baseline (Day 0) to Last Treatment (Up to Week 48)
Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score
The participant assessed satisfaction using the 5 items on the Satisfaction of Lower Face and Jawline module of the FACE-Q™ questionnaire, measured on a 4-point scale where: 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied. The Rasch transformed scale total score was 0 (worst) to 100 (best). A positive change from baseline indicated improvement.
Measured: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck
The participant assessed satisfaction using the 10 items on the Appraisal of Neck module of the FACE-Q™ questionnaire measured on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, 4=extremely. The Rasch transformed scale total score was 0 (worst) to 100 (best). A positive change from baseline indicated improvement.
Measured: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin
The participant assessed satisfaction using the 5 items on the Appraisal of Area Under Chin module of the FACE-Q™ questionnaire measured on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, 4=extremely. The Rasch transformed scale total score was 0 (worst) to 100 (best). A negative change from baseline indicated worsening.
Measured: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The CR-SMFRS score was based on the investigator's clinical evaluation of the participant, where submental fullness was scored on a 5-point scale where: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme. A negative change from baseline indicated improvement.
Measured: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The PR-SMFRS was based on the participant's response to the question "How much fat do you have under your chin right now?" and answered on a 5-point ordinal scale where: 0=no chin fat at all, 1=a slight amount of chin fat, 2=a moderate amount of chin fat, 3=a large amount of chin fat, and 4=a very large amount of chin fat. A negative change from baseline indicated improvement.
Measured: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score
The SMSLG scale integrated 3 skin features: skin wrinkling, adherence to underlying neck structures (bone and muscle), and redundancy (horizontal and vertical folds) assessed by the investigator using a 4-point scale where: 1=none, 2=mild, 3=moderate and 4=severe. A negative change from baseline indicated improvement.
Measured: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
The independent reviewer used photographic images collected at the time of the participant's live visit and the ALJDS to assess of loss of jawline definition using a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. A negative change from baseline indicates improvement.
Measured: Baseline (Day 0) to Week 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start2 Feb 2018
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
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 ContourStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Silberberg, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425253
- Sponsor's protocol ID
- CMO-MA-FAS-0513
- Acronym
- JAWLINE
- Status last verified
- Dec 2020
- First submitted
- 1 Feb 2018
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Study to Evaluate Sequential Treatment With BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
- ClinicalTrials.gov ID
- NCT03425253
- Acronym / sponsor ID
- JAWLINE / CMO-MA-FAS-0513
- Conditions
- Contour
- Keywords
- Lower Face Contouring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been designed to evaluate the safety and effectiveness of sequential treatment with BELKYRA® (for the treatment of convexity and fullness associated with submental fat) and VOLUMA™ (to restore volume along the mandibular border) to enhance the overall contour of the jawline.
Detailed description
Participants may be treated with up to 6 treatments with Belkyra, followed by treatment with Voluma. Participants will have opportunity to participation in a skin biopsy sub-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine | Experimental | Drug: BELKYRA®, Device: Juvéderm® VOLUMA™ with LidocaineBELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Grade 2 or above on Allergan Loss of Jawline Definition Scale (ALJDS)
- Grade 2 or 3 on reported Clinician-Rated Submental Fat Rating Scale (CR-SMFRS)
- Stable body weight for at least 26 weeks
- Accept the obligation to forego any treatment or behavior (e.g., unshaven facial hair; significant changes to dietary or exercise habits) during the participants participation in the study that may affect the assessments of the submental area
Key exclusion criteria (17 listed)
- Grade 4 on Submental Skin Laxity Grade (SMSLG)
- Grade 4 on Allergan Jowl Fat Rating Scale (AJFRS)
- Body mass index (BMI) >35 kg/m^2
- History of, or current symptoms of dysphagia
- History of temporary, semi-permanent or permanent facial or neck dermal filler injections below the medial canthi at any time prior to treatment, or within 52 weeks before Screening for treatment above the medial canthi
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 |
|---|---|---|
| BELKYRA®BELKYRA® was injected into preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). | Drug | BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine |
| Juvéderm® VOLUMA™ with LidocaineJuvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border. | Device | BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine |
Primary outcome
Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator
Time frame: Baseline (Day 0) to Week 58
The ALJDS was an investigator assessment of loss of jawline definition measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. Data is reported for both sides of the face, right side of the face and left side of the face.
8 secondary outcomes
Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Time frame: Baseline (Day 0) to Last Treatment (Up to Week 48)
Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score
Time frame: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck
Time frame: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin
Time frame: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time frame: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time frame: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score
Time frame: Baseline (Day 0) to Week 58
Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
Time frame: Baseline (Day 0) to Week 58
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Contour
Not yet recruiting
Automated Radiation Target Contouring and Treatment Planning Via RATA: A Multi-Center RCT
Cancer, Malignant Neoplasms
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
Active, not recruitingObservational study
A Study to Evaluate the Benefits of Harmonic Vibration Liposuction
Liposuction, Body Contouring Surgery
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.
Michael Silberberg study director
Allergan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine in people with Contour, run by Allergan at 3 sites in Australia.
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 17 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). 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 Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator (time frame: Baseline (Day 0) to Week 58). 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 31 Dec 2020.