biostudies-literatureUnknown21(6)Jalian HRAllergan<h4>Background</h4>Submental fat (SMF) detracts from facial aesthetics and negatively impacts self-image.<h4>Aims</h4>To evaluate safety, effectiveness, and satisfaction of cryolipolysis and ATX-101 used sequentially to reduce SMF.<h4>Methods</h4>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.<h4>Results</h4>Of 16 enrolJournal of cosmetic dermatology2437-2444https://www.ebi.ac.uk/biostudies/studies/S-EPMC9325515biostudies-literatureSubmental fat reduction using sequential treatment approach with cryolipolysis and ATX-101.PMC9325515Bowen BFitzgerald RJalian HRGamio SfalseSubmental fat reduction using sequential treatment approach with cryolipolysis and ATX-101.<h4>Background</h4>Submental fat (SMF) detracts from facial aesthetics and negatively impacts self-image.<h4>Aims</h4>To evaluate safety, effectiveness, and satisfaction of cryolipolysis and ATX-101 used sequentially to reduce SMF.<h4>Methods</h4>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.<h4>Results</h4>Of 16 enrol2022-01-01T00:00:00Z2022 Jun2025-04-18T15:36:52.205Z2025-04-07T02:20:29.318ZS-EPMC93255153527826210.1111/jocd.14909