Efficacy and Safety of Cold-Induced Noninvasive Targeted Fat Reduction in Pseudogynecomastia.

Abstract

Background: Treatment options for pseudogynecomastia are limited, and the demand for noninvasive breast fat reduction is increasing.

Objective: We evaluated the efficacy and safety of a cold-induced lipolysis device for treating pseudogynecomastia.

Methods: In this 16-week prospective trial, a total of 15 male patients with pseudogynecomastia were treated twice with cryolipolysis. The primary endpoint was a change in the chest circumference from baseline at posttreatment week 8. Secondary endpoints were changes in body weight, fat thickness assessed using ultrasonography, independent evaluator- and patient-rated improvement, and Simon's gynecomastia class (SGC) grading.

Results: The primary assessment, a reduction of 3.05 cm in the mean chest circumference at 8 weeks post-treatment compared to baseline, was statistically significant. The treatment effect was cumulative, with a steady decrease in chest circumference and fat thickness over the 16-week study period. The mean pain score immediately after the first session of treatment was 2.0±1.36, based on a scale of 0~10, with a score of 10 being the worst pain ever experienced. The pain decreased substantially after the end of the procedure.

Conclusion: Cryolipolysis was demonstrated to be an effective and safe option for reducing breast fat in pseudogynecomastia. Male with mild to moderate breast enlargement without skin excess can be ideal candidates.