title: Prospective multicenter clinical trial of a minimally invasive temperature-controlled bipolar fractional radiofrequency system for rhytid and laxity treatment.
abstract: BACKGROUND
  A minimally invasive fractional bipolar radiofrequency (FRF) was developed.
  
  
  OBJECTIVE
  To evaluate safety and efficacy of FRF in reducing face and neck rhytides and laxity.
  
  
  METHODS
  This prospective, open-label, multicenter clinical trial enrolled 100 subjects with mild to severe facial and neck rhytides and laxity at seven centers in a per-protocol analysis. One single-pass FRF treatment was administered through five 32 g-needle electrode pairs at a preselected real-time fixed temperature of 62 to 78°C, energy duration for 3 to 5 seconds, and impedance restrictions of 200 to 3,000 Ohms, ensuring intradermal delivery. Five blinded dermatologists and plastic surgeons graded randomized standardized baseline and follow-up photographs of 53 and 42 subjects at 3- and 6-month follow-up intervals, respectively, using the Fitzpatrick wrinkle and Alexiades-Armenakas laxity scales. Subject assessments and adverse events were recorded in 100 subjects.
  
  
  RESULTS
  Blinded evaluations revealed correct pre- and post-treatment identification in 100% of scored cases, mean improvement of 25.6% on the Fitzpatrick Wrinkle Scale and 24.1% on the Alexiades-Armenakas laxity scale at 6 months, and 100% response rate for rhytides and 95% for laxity. Subgroup analysis revealed maximal rhytid reduction in the mean target temperature of 66.7, energy duration of 4.2 seconds, and volume of denatured collagen of mm(3)  denatured collagen group. Adverse events included transient erythema, edema, and ecchymoses, resolving within 1 to 5 days, and two incidents of temporary pinpoint depressions. More than 90% of subjects were satisfied or very satisfied.
  
  
  CONCLUSIONS
  Real-time temperature-controlled FRF is a highly reproducible, safe, effective nonsurgical treatment of face and neck rhytides and laxity and provides important insights into neocollagenesis, neoelastogenesis, and clinical outcomes.
authors.affiliation: School of Medicine, Yale University, New Haven, Connecticut, USA. dralexiades@nyderm.org
authors.forename: Macrene
authors.initials: M
authors.lastname: Alexiades-Armenakas
authors.forename: James
authors.initials: J
authors.lastname: Newman
authors.forename: Andrea
authors.initials: A
authors.lastname: Willey
authors.forename: Suzanne
authors.initials: S
authors.lastname: Kilmer
authors.forename: David
authors.initials: D
authors.lastname: Goldberg
authors.forename: Jerome
authors.initials: J
authors.lastname: Garden
authors.forename: David
authors.initials: D
authors.lastname: Berman
authors.forename: Braden
authors.initials: B
authors.lastname: Stridde
authors.forename: Bradley
authors.initials: B
authors.lastname: Renton
authors.forename: Dany
authors.initials: D
authors.lastname: Berube
authors.forename: Basil M
authors.initials: BM
authors.lastname: Hantash
mesh_terms: D000328:Adult; D000368:Aged; D004598:Electrosurgery / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D011446:Prospective Studies; D015361:Rhytidoplasty / Q000379:methods*; D015595:Skin Aging; D016896:Treatment Outcome