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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03425253




Registration number
NCT03425253
Ethics application status
Date submitted
1/02/2018
Date registered
7/02/2018
Date last updated
23/01/2020

Titles & IDs
Public title
Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
Scientific title
A Prospective, Open-label Study to Evaluate Sequential Treatment With BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
Secondary ID [1] 0 0
CMO-MA-FAS-0513
Universal Trial Number (UTN)
Trial acronym
JAWLINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contour 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BELKYRA®
Treatment: Devices - Juvéderm® VOLUMA™ with Lidocaine

Experimental: BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine - BELKYRA® is injected into preplaytsmal fat tissue in the submental area. When the Investigator and subject agree that no further intervention is required to achieve the desired result, subjects will be eligible to receive VOLUMA™ treatment. VOLUMA™ is injected along the mandibular border.


Treatment: Drugs: BELKYRA®
BELKYRA® is injected into preplaytsmal fat tissue in the submental area. When the Investigator and subject agree that no further intervention is required to achieve the desired result, subjects will be eligible to receive VOLUMA™ treatment.

Treatment: Devices: Juvéderm® VOLUMA™ with Lidocaine
VOLUMA™ is injected along the mandibular border.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects who show = 1-point jawline improvement from baseline on the Allergan Loss ofJawline Definition Scale (ALJDS) - The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)
Timepoint [1] 0 0
Baseline to Week 58
Secondary outcome [1] 0 0
Change from baseline to last BELKYRA® treatment on ALJDS - The ALJDS is an Investigator assessment of jawline contour measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)
Timepoint [1] 0 0
Baseline to up to 48 Weeks
Secondary outcome [2] 0 0
Change from baseline to final study visit for FACE-Q™ Satisfaction with lower face and jawline score - The subject will assess 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 (1=Not at all, 2=A little, 3=Moderately, 4=Extremely)
Timepoint [2] 0 0
Baseline to Week 58
Secondary outcome [3] 0 0
Change from baseline to final study visit for FACE-Q™ Appraisal of Neck - The subject will assess satisfaction using the 10 items on the Neck module of the FACE-Q™ questionnaire measured on a 4-point scale (1=Not at all, 2=A little, 3=Moderately, 4=Extremely)
Timepoint [3] 0 0
Baseline to Week 58
Secondary outcome [4] 0 0
Change from baseline to final study visit for FACE-Q™ Appraisal of Area under Chin - The subject will assess satisfaction using the 5 items on the Appraisal of Area Under Chin module of the FACE-Q™ questionnaire measured on a 4-point scale (1=Not at all, 2=A little, 3=Moderately, 4=Extremely)
Timepoint [4] 0 0
Baseline to Week 58
Secondary outcome [5] 0 0
Change from baseline to final study visit for CR (Clinician-Reported) Submental Fat Rating Scale (SMFRS) - The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). A negative change from baseline indicates improvement.
Timepoint [5] 0 0
Baseline to Week 58
Secondary outcome [6] 0 0
Change from baseline to final study visit for PR (Patient-Reported) Submental Fat Rating Scale (SMFRS) - The PR-SMFRS is 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 (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 indicates improvement.
Timepoint [6] 0 0
Baseline to Week 58
Secondary outcome [7] 0 0
Change from baseline to final study visit for Submental Skin Laxity Grade (SMSLG) score - SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures, and redundancy with 1=none, 2=mild, 3=Moderate and 4=severe.
Timepoint [7] 0 0
Baseline to Week 58
Secondary outcome [8] 0 0
Change from baseline to final study visit in jawline definition based on Independent Reviewer assessment using the ALJDS and photographic images - The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)
Timepoint [8] 0 0
Baseline to Week 58

Eligibility
Key inclusion criteria
- Grade 2 or above on ALJDS

- Grade 2 or 3 on 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 subject's participation
in the study that may affect the assessments of the submental area
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Grade 4 on SMSLG

- Grade 4 on AJFRS (Allergan Jowl Fat Rating Scale)

- BMI >35 kg/m2

- 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

- Subjects 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Darlinghurst Dermatology - Darlinghurst
Recruitment hospital [2] 0 0
Living Art - East Melbourne
Recruitment hospital [3] 0 0
Dermatology Institute of Victoria - South Yarra
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3141 - South Yarra

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03425253
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Silberberg
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications