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

Allergan

Status and phase: Completed; Phase 4

Conditions: Contour

Treatments: Drug: BELKYRA®; Device: Juvéderm® VOLUMA™ with Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03425253

CMO-MA-FAS-0513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

BELKYRA® and Juvéderm® VOLUMA™ with Lidocaine

Experimental group

Description:

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.

Treatment:

Device: Juvéderm® VOLUMA™ with Lidocaine

Drug: BELKYRA®