Clinical trial NCT03425253: Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
Official title: A Prospective, Open-label Study to Evaluate Sequential Treatment With BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contour
Keywords: Lower Face Contouring
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-02-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline (Day 0) to Week 58
Secondary outcomes:
measure: Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
timeFrame: Baseline (Day 0) to Last Treatment (Up to Week 48)
measure: Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score
timeFrame: Baseline (Day 0) to Week 58
measure: Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck
timeFrame: Baseline (Day 0) to Week 58
measure: Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin
timeFrame: Baseline (Day 0) to Week 58
measure: Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
timeFrame: Baseline (Day 0) to Week 58
measure: Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
timeFrame: Baseline (Day 0) to Week 58
measure: Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score
timeFrame: Baseline (Day 0) to Week 58
measure: Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
timeFrame: Baseline (Day 0) to Week 58
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Darlinghurst Dermatology
state: New South Wales
city: East Melbourne
country: Australia
facility: Living Art
state: Victoria
city: South Yarra
country: Australia
facility: Dermatology Institute of Victoria
state: Victoria
Study officials:
affiliation: Allergan
name: Michael Silberberg
role: STUDY_DIRECTOR
References: