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.
RCT Entities:
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.
Authors: Yona Tadir; Adrian Gaspar; Ahinoam Lev-Sagie; Macrene Alexiades; Red Alinsod; Alex Bader; Alberto Calligaro; Jorge A Elias; Marco Gambaciani; Jorge E Gaviria; Cheryl B Iglesia; Ksenija Selih-Martinec; Patricia L Mwesigwa; Urska B Ogrinc; Stefano Salvatore; Paolo Scollo; Nicola Zerbinati; John Stuart Nelson Journal: Lasers Surg Med Date: 2017-02-21 Impact factor: 4.025