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

Allergan58 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contour

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Darlinghurst Dermatology

Darlinghurst, New South Wales, Australia

Living Art

East Melbourne, Victoria, Australia

Dermatology Institute of Victoria

South Yarra, Victoria, Australia

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Day 0) to Week 58

Secondary Outcomes

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.

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

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.

Time frame: 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.

Time frame: Baseline (Day 0) to Week 58

Data from ClinicalTrials.gov

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