Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour (JAWLINE)

December 4, 2020 updated by: Allergan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Darlinghurst Dermatology
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Living Art
      • South Yarra, Victoria, Australia, 3141
        • Dermatology Institute of Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: 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).
Device: Juvéderm® VOLUMA™ with Lidocaine
Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0) to Week 58

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Time Frame: Baseline (Day 0) to Last Treatment (Up to Week 48)
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Baseline (Day 0) to Week 58

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Silberberg, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMO-MA-FAS-0513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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