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November 2012

1306

VOLUME 11 • ISSUE 11

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.
Conclusion: 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.

J Drugs Dermatol. 2012;11(11):1306-1309.

INTRODUCTION

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 magnetic pulses was recently introduced and is supposed to be effective in the treatment of facial wrinkles and virtually pain free.

The use of RF to tighten skin was first described by Ruiz-Esparza and Gomez in 2003.1 The technique is based on volumetric heating of dermal tissue to initiate a denaturation of collagen accompanied by an immediate contraction of the fibers and a subsequent neocollagenesis.2,3 The heat generation is based on the tissue's natural resistance to the movement of ions within an electromagnetic field and other than lasers not diminished by tissue diffraction or absorption by epidermal melanin. As such, RF-based systems are appropriate for any skin type.4 However, the shrinkage of collagen is not dependent on a specific temperature, but is determined by a combination of time and temperature.5 This fact allows slow approaches with target temperatures around 60°C to 65°C as well as millisecond approaches with a target temperature of 85°C to be effective.6 As higher temperatures are accompanied by an increased risk of side effects and significant pain,7 slow approaches with lower target temperatures thereby seem to be safer and less uncomfortable for patients.

The safety and pain of RF treatments can also depend on the number of electrodes. Unipolar systems are associated with significant pain and a high rate of adverse effects such as second- degree burns due to the concentrated and deep-reaching heat production at their single electrode,8 whereas bipolar and multipolar systems distribute the heat energy equally and more surficially between their electrodes, resulting in minimal pain and a better safety profile.9,10 Alexiades-Armenakas et al11 compared the unipolar and bipolar modes of an RF device with an uncommonly high frequency of 41 MHz in a randomized, blinded

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