Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
NCT ID: NCT03425253
Last Updated: 2020-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2018-02-02
2019-12-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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).
Juvéderm® VOLUMA™ with Lidocaine
Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.
Interventions
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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).
Juvéderm® VOLUMA™ with Lidocaine
Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Silberberg
Role: STUDY_DIRECTOR
Allergan
Locations
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Darlinghurst Dermatology
Darlinghurst, New South Wales, Australia
Living Art
East Melbourne, Victoria, Australia
Dermatology Institute of Victoria
South Yarra, Victoria, Australia
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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CMO-MA-FAS-0513
Identifier Type: -
Identifier Source: org_study_id