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Unipolar versus bipolar radiofrequency treatment of rhytides and laxity using a mobile painless delivery method
Author(s) -
AlexiadesArmenakas Macrene,
Dover Jeffrey S.,
Arndt Kenneth A.
Publication year - 2008
Publication title -
lasers in surgery and medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.888
H-Index - 112
eISSN - 1096-9101
pISSN - 0196-8092
DOI - 10.1002/lsm.20667
Subject(s) - medicine , erythema , grading scale , randomized controlled trial , random assignment , grading (engineering) , surgery , high energy , civil engineering , engineering physics , pathology , engineering
Background Previous studies have shown that radiofrequency (RF) energy is a safe and effective treatment for rhytide‐reduction. Objective This randomized, blinded, split‐face study assesses the safety and efficacy of the unipolar versus bipolar handpieces on an RF device with a mobile delivery method for the treatment of rhytides and laxity using quantitative grading. Methods In this randomized, blinded, split‐face design study, 10 subjects (aged 18–75 years) with a clinically observable excess of rhytides and laxity (minimum grade 2 out of 4) on the face received four treatments at 1‐week intervals with random assignment of unipolar RF to one side and bipolar RF to the contralateral side. Each side received approximately four passes per treatment delivered in a mobile continuous manner. Results were evaluated by two blinded investigators of photographs employing a comprehensive 4‐point grading scale at baseline, and 1‐ and 3‐month follow‐up visits after the final treatment. Results All subjects completed and responded to treatment. The blinded evaluations demonstrated the following mean percent improvements in grading scores of rhytides and laxity: for the unipolar side 6.0±4.6% and 4.6±4.8% versus the bipolar side 4.4±2.5 and 7.3±3.5%. The degree of improvement approached but did not achieve statistical significance for either handpiece, but demonstrated a trend toward improvement ( P = 0.5599 unipolar vs. 0.1108 bipolar). The treatment was painless (rated 0 out of 10 by all subjects) and side effects included minimal erythema which resolved within 1–3 hours. No crusting, dyspigmentation or scarring was observed. Conclusion This randomized, split‐face study with blinded evaluations employing a quantitative grading scale demonstrated that minimal pass, mobile energy delivery serial treatments with either the unipolar or bipolar handpieces of a novel RF device appears to safe and painless. Each handpiece demonstrated minimal clinical efficacy which was not statistically significant, but with a trend toward improvement in rhytides and laxity of facial skin. Lesers Surg. Med. 40:446–453, 2008. © 2008 Wiley‐Liss, Inc.