title: Treatment of wrinkles and elastosis using vacuum-assisted bipolar radiofrequency heating of the dermis.
abstract: BACKGROUND
  Reduction of wrinkles is increasingly becoming one of the most sought after aesthetic procedures. A variety of treatment modalities are available for this application, including radiofrequency energy in various modes of action.
  
  
  OBJECTIVE
  The goal of the reported study was to evaluate the safety and efficacy of a new device, which implements an innovative combination of bipolar radiofrequency and vacuum.
  
  
  METHODS
  Forty-six healthy adults at two clinics underwent eight facial treatments every 1 to 2 weeks. For 6 months after treatment, patients were assessed directly by two evaluators at each clinic (the treating physician and an additional reviewer) using standard evaluation tools-the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis and a visual analog scale.
  
  
  RESULTS
  Significant improvement in the skin's appearance and texture was observed during the treatment course and continued to increase during the follow-up period. The mean elastosis score on the wrinkling and elastosis scale before treatment was 4.5 and was reduced to less than 2.5 by 6 months after treatment, representing a drop of an entire wrinkle class (from II to I) on this scale. The reported pain levels were low, and the subjects expressed their satisfaction with the treatment and its outcome. The adverse responses consisted mainly of transient erythema and burn/blistering; there were also a few occurrences of edema, purpura, and crusting and one transient hyperpigmentation. No permanent complications had occurred.
  
  
  CONCLUSIONS
  Our results demonstrate the safety and efficacy associated with use of this radiofrequency and vacuum device, employing Functional Aspiration Controlled Electrothermal Stimulation (FACES) technology, for reduction of facial wrinkles and elastosis.
authors.affiliation: Gold Skin Care Center and Tennessee Clinical Research Center, Nashville, Tennessee, USA.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Gold
authors.forename: Mitchel P
authors.initials: MP
authors.lastname: Goldman
authors.forename: Jaggi
authors.initials: J
authors.lastname: Rao
authors.forename: Alex S
authors.initials: AS
authors.lastname: Carcamo
authors.forename: Michelle
authors.initials: M
authors.lastname: Ehrlich
mesh_terms: D000368:Aged; D004548:Elasticity; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D006358:Hot Temperature / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D000078702:Radiofrequency Therapy; D015595:Skin Aging / Q000528:radiation effects*; D016896:Treatment Outcome; D014618:Vacuum