Evaluation of a combined laser-radio frequency device (Polaris WR) for the nonablative treatment of facial wrinkles

Abstract

Nonablative wrinkle reduction or skin tightening is desired by individuals who, ideally, hope to have the skin improvement associated with chemical or laser ablative techniques but without the undesirable recovery process. Electro-optical synergy (ELOS) technology that combines radio frequency (RF) and diode laser energy (900 nm) was used to treat 15 patients in this IRB sanctioned study. Energy settings were based on the depth of wrinkles (the greater the depth and concentration of wrinkles, the higher the RF setting) and ranged from 50-100 J/cm2 RF and 15 J/cm2 for the optical, laser component. Patients received three full-face treatments, and results were evaluated by comparison of standardized photographs and patient questionnaire given prior to each treatment and one month after the third treatment. The primary investigator and three other "blinded" physicians evaluated these photographs using Fitzpatrick's wrinkle classification to assess the improvement, if any, between the initial and final visit. Eight patients completed the study. Explanation for the exclusion of the remaining six patients were: one decided to have surgery, two felt the treatment was too painful, and three moved out of the area. Following treatment, all patients had mild swelling (resolved <48 hours) and skin hyperemia (resolved <24 hours). Results observed one month after the last treatment in eight patients demonstrated an average of 25% reduction in skin wrinkles (range 14%-32%). There were no adverse side effects. The major concern of the patients was the discomfort associated with the treatment. As part of an FDA investigation to assess efficacy, long-term follow-up was not a part of this study protocol.