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

Abstract

BackgroundSubmental fat (SMF) detracts from facial aesthetics and negatively impacts self‐image.AimsTo evaluate safety, effectiveness, and satisfaction of cryolipolysis and ATX‐101 used sequentially to reduce SMF.MethodsA 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.ResultsOf 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.ConclusionSequential treatment with cryolipolysis and ATX‐101 was found safe and effective for reducing extreme SMF, resulting in approximately a 2‐grade improvement.