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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03425253
Registration number
NCT03425253
Ethics application status
Date submitted
1/02/2018
Date registered
7/02/2018
Date last updated
31/12/2020
Titles & IDs
Public title
Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
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Scientific title
A Prospective, Open-label Study to Evaluate Sequential Treatment With BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
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Secondary ID [1]
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CMO-MA-FAS-0513
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Universal Trial Number (UTN)
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Trial acronym
JAWLINE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Contour
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BELKYRA®
Treatment: Devices - Juvéderm® VOLUMA™ with Lidocaine
Experimental: BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine - 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.
Treatment: Drugs: 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).
Treatment: Devices: Juvéderm® VOLUMA™ with Lidocaine
Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 0) to Week 58
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Secondary outcome [1]
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 0) to Last Treatment (Up to Week 48)
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Secondary outcome [2]
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Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (Day 0) to Week 58
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Secondary outcome [3]
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Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (Day 0) to Week 58
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Secondary outcome [4]
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Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline (Day 0) to Week 58
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Secondary outcome [5]
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Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (Day 0) to Week 58
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Secondary outcome [6]
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Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline (Day 0) to Week 58
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Secondary outcome [7]
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Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline (Day 0) to Week 58
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Secondary outcome [8]
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Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline (Day 0) to Week 58
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Eligibility
Key inclusion criteria
- 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/02/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/12/2019
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Sample size
Target
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Accrual to date
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Final
58
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Darlinghurst Dermatology - Darlinghurst
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Recruitment hospital [2]
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Living Art - East Melbourne
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Recruitment hospital [3]
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Dermatology Institute of Victoria - South Yarra
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment postcode(s) [3]
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3141 - South Yarra
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03425253
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Silberberg
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03425253
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