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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Scr…
What they're measuring
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