Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat.

BACKGROUND

Recently, it has been reported that a micro-insulated needle radiofrequency (RF) system is effective at achieving subcutaneous fat reduction; however, no study has yet applied this technique to reduce submental fat.

OBJECTIVE

To evaluate the efficacy and safety of a fractional RF device with a micro-insulated needle to reduce submental fat.

MATERIALS AND METHODS

In this prospective, single-blinded, pre-post comparative study, 24 adults with excess submental fat were treated once using a micro-insulated needle RF device. Outcomes included efficacy (submental fat rating by an independent investigator, fat volume quantified with a 3-dimensional camera, and patient satisfaction), assessed 1 and 2 months after the procedure, and safety (adverse events), assessed throughout the study.

RESULTS

The patients' Physician-Assisted Submental Fat Rating Scale score significantly decreased after 1 month and further decreased after 2 months. The average volume of submental fat was significantly decreased after 2 months (20.44 ± 5.53 cc to 16.41 ± 4.58 cc, p < .001). Patient satisfaction was high. Transient and mild local skin reactions without long-term sequelae were observed in 4 patients.

CONCLUSION

The micro-insulated needle RF device is beneficial for the reduction of submental fat and has tolerable safety profiles.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT05517824.