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

NCT03425253 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: CMO-MA-FAS-0513
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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.

Conditions

Contour

Keywords

Lower Face Contouring

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 0) to Week 58

Secondary Outcomes (8)

• Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS

  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

  Baseline (Day 0) to Week 58

• Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck

  Baseline (Day 0) to Week 58

• Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin

  Baseline (Day 0) to Week 58

• Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

  Baseline (Day 0) to Week 58

Study Arms (1)

BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine

EXPERIMENTAL

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®; Device: Juvéderm® VOLUMA™ with Lidocaine

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).

BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine

Juvéderm® VOLUMA™ with Lidocaine DEVICE

Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.

BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Darlinghurst Dermatology

Darlinghurst, New South Wales, 2010, Australia

Location

Living Art

East Melbourne, Victoria, 3002, Australia

Location

Dermatology Institute of Victoria

South Yarra, Victoria, 3141, Australia

Location

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Michael Silberberg

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 7, 2018
• Study Start: February 2, 2018
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)