title: Safety and efficacy of a new device combining radiofrequency and low-frequency pulsed electromagnetic fields for the treatment of facial rhytides.
abstract: BACKGROUND
  A distinct trend in aesthetic medicine is the patient's demand for efficient, noninvasive treatments with no downtime. Ongoing with this, these so-called lunchtime procedures are expected to be as safe and painless as possible. A new technique based on a combination of radiofrequency (RF) and pulsed electromagnetic fields (PEMF) was recently introduced and is supposed to be effective in the treatment of facial wrinkles and virtually pain free. The objective of this study was to investigate the safety and efficacy of this technology for the treatment of facial rhytides.
  
  
  METHODS
  Thirty-one subjects with facial wrinkles and rhytides were entered into this study. Every subject received 10 treatments of the face with a device that combines 1 MHz radiofrequency with PEMF with a flux of 15 gauss. Patients rated the pain level immediately after the treatment by using a visual analog scale (VAS) for pain. Side effects were recorded at every visit. The study's efficacy end point was evaluated by 2 blinded physicians who rated the standardized pictures from baseline and 3-month follow-up using the Fitzpatrick Wrinkle and Elastosis Scale (FWES).
  
  
  RESULTS
  No unexpected adverse side effects were detected or reported for the duration of the study. Both raters recognized improvements of at least 1 grade on the FWES in 30 of 31 subjects (97%). The score decreased from 5.2 before the first treatment to 3.6 at 3 months after the last treatment. Furthermore, all patients rated the treatment to be free of pain on the VAS pain scale.
  
  
  CONCLUSIONS
  The results of this study show that the combination of multipolar RF with PEMF is a safe, effective, and painless approach to treat facial rhytides and is suitable to answer the demands of patients for safe treatments without pain or downtime.
authors.affiliation: Division of Cosmetic Science, University of Hamburg, Hamburg, Germany.
authors.forename: Nils
authors.initials: N
authors.lastname: Krueger
authors.forename: Hanna
authors.initials: H
authors.lastname: Levy
authors.forename: Neil S
authors.initials: NS
authors.lastname: Sadick
mesh_terms: D000328:Adult; D003357:Cosmetic Techniques / Q000009:adverse effects; D004574:Electromagnetic Fields / Q000009:adverse effects; D004867:Equipment Design; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D011846:Radio Waves / Q000009:adverse effects; D000078702:Radiofrequency Therapy; D016037:Single-Blind Method; D015595:Skin Aging