Safety, Efficacy, and Tolerability of Simultaneous Bilateral Cryolipolysis Using a Rapid Cycling Contoured Cup Applicator for Noninvasive Fat Reduction in the Enlarged Male Breast: A Pilot Study.

Abstract

A previous study using a parallel cooling plate cryolipolysis applicator demonstrated the efficacy of cryolipolysis for pseudogynecomastia. Although the procedure was safe and effective, treatment times were prolonged and anesthetic was needed to reduce treatment discomfort. To evaluate the safety, efficacy, and tolerability of a short cycle, reduced vacuum contoured cup cryolipolysis applicator for the treatment of pseudogynecomastia. Twelve male subjects received simultaneous bilateral treatment consisting of a 35-minute cryolipolysis cycle, followed by a short manual massage, and a second 35-minute cycle with 50% treatment area overlap in a single treatment visit. At the 6-week follow-up, a second treatment was performed with up to 2 overlapping cycles per side. Efficacy was assessed after the second treatment using transcutaneous ultrasound, standardized clinical photography, and subject surveys. Ultrasound analysis showed a mean fat layer reduction of 5.1 ± 2.3 mm (p < .001). Blinded, independent reviewers correctly identified 97% of baseline/treatment photography results. Surveys revealed 100% subject satisfaction with 91% reporting visible fat reduction and 100% stating they would recommend treatment. Transient side effects included mild intratreatment discomfort, paresthesia, and tenderness. A rapid cycling, reduced vacuum cryolipolysis applicator provides rapid, safe, effective, and tolerable treatment of pseudogynecomastia.