Submental fat reduction using sequential treatment approach with cryolipolysis and ATX-101.

ABSTRACT

BACKGROUND: Submental fat (SMF) detracts from facial aesthetics and negatively impacts self-image. AIMS: To evaluate safety, effectiveness, and satisfaction of cryolipolysis and ATX-101 used sequentially to reduce SMF. METHODS: A prospective, open-label, interventional, single-site study enrolling 22- to 65-year-old participants rated as Grade 4 (extreme) on the Clinician-Rated SMF Rating Scale (CR-SMFRS). Co-primary effectiveness endpoints were proportions of participants with ≥1-grade and ≥2-grade improvement on CR-SMFRS at 12 weeks post final treatment. Additional assessments included ultrasound measurement of fat thickness and Subject Self-Rating Scale (SSRS) scores at 12 weeks post final treatment. Safety was assessed throughout the study. RESULTS: Of 16 enrolled participants, 62.5% were female, mean age of 43, and mean body mass index of 31.8 kg/m2 . 100% of participants achieved ≥1-grade improvement, and 71.4% achieved ≥2-grade CR-SMFRS improvement. Mean (SD) reduction in SMF thickness was 0.2 mm (1.3), and SSRS scores ≥4 (slightly to extremely satisfied) were reported by 71.4% of participants. Adverse events (AEs) were mild and resolved by study end. No unanticipated adverse device effects or serious or unexpected AEs occurred. CONCLUSION: Sequential treatment with cryolipolysis and ATX-101 was found safe and effective for reducing extreme SMF, resulting in approximately a 2-grade improvement.