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

BACKGROUND 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. OBJECTIVE To evaluate the safety, efficacy, and tolerability of a short cycle, reduced vacuum contoured cup cryolipolysis applicator for the treatment of pseudogynecomastia. MATERIALS AND METHODS 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. RESULTS Ultrasound analysis showed a mean fat layer reduction of 5.1 6 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. CONCLUSION A rapid cycling, reduced vacuum cryolipolysis applicator provides rapid, safe, effective, and tolerable treatment of pseudogynecomastia.

Cryolipolysis in the United States—Review of the clinical data

“…The observed satisfaction rates ranged from 82% to 100%. The accuracy of identification by the blinded investigators ranged from 79% to 100% 12–26 …”

“…The number of treatment cycles ranged from one to two, depending on the treatment site. Notably, the flank region displayed an average treatment cycle of 1.14 across the conducted studies, while areas like the submentum and breast region had an average of two treatment cycles 12–26 …”

“…Notably, the flank region displayed an average treatment cycle of 1.14 across the conducted studies, while areas like the submentum and breast region had an average of two treatment cycles. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] The assessment of objective outcome measures included ultrasound measurements, body caliper measurements, and 3D imaging (VECTRA). Utilizing these outcome measures, the investigated studies each exhibited statistically significant reductions in average fat content within the treated areas.…”

“…The accuracy of identification by the blinded investigators ranged from 79% to 100%. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] Of note, two studies implemented a dual-session treatment approach that influenced both the satisfaction and identification Friedmann's satisfaction rate increased from 50% to 100% and was accompanied by a corresponding increase in the correct blinded evaluator identification rate from 77% to 100%. 25 Similarly, Munavalli et al reported an increase in satisfaction rate from 79% to 95% after the second round of treatment.…”