Evaluation of safety and efficacy of the TriPollar technology for treatment of wrinkles.

Introduction: Patient demand for non-surgical, non-invasive, and no-downtime wrinkle reduction treatment procedures has grown dramatically over the past decade as new treatments and technologies have been introduced. This study was performed in order to evaluate the safety and efficacy of the TriPollar radiofrequency (RF) technology and intended for wrinkle reduction treatment.

Methods: Thirty-seven Subjects were recruited in two sites and were treated for the reduction of facial wrinkles and rhytides and followed for 3 months after the last treatment. The safety of using the TriPollar system was established by the physicians' assessments and observations of adverse events after each treatment. To evaluate treatment efficacy, pre- and post-treatment photos were assessed using a blinded evaluation by two uninvolved physicians.

Results: No unexpected adverse side effects were detected or reported. All subjects participating in the study reported no pain or mild pain during the treatments. The photographic analysis of pre- and post-treatment by the two blinded physicians revealed improvement (downgrade of at least 1 score according to the Fitzpatrick scale) in 94% (according to first reviewer) and 97% (according to second reviewer) of study subjects. All patients (100%) were satisfied from treatment results to a different extent.

Conclusions: The results of this study clearly indicate that the TriPollar system offers a non-invasive, effective, safe and virtually painless wrinkle and rhytides reduction treatment.