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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 enrol
SUBMITTER: Jalian HR
PROVIDER: S-EPMC9325515 | biostudies-literature | 2022 Jun
REPOSITORIES: biostudies-literature