title: Safety, efficacy, and usage compliance of home-use device utilizing RF and light energies for treating periorbital wrinkles.
abstract: BACKGROUND
  The aging process is often associated with undesirable effects on facial skin such as skin redundancy, reduction of elasticity, and increased wrinkling. Radiofrequency (RF) and light-emitting diodes (LEDs) are widely used, clinically proven technologies for skin rejuvenation.
  
  
  OBJECTIVE
  This study aimed to evaluate the safety, efficacy, and usage compliance of the home-use device, utilizing RF and LED energies, for self-treatment of periorbital wrinkles and improvement of skin appearance.
  
  
  METHODS
  Thirty-three subjects performed 21 treatment sessions every other day, over 6 weeks on the periorbital areas. In addition, two maintenance treatments were conducted 1 and 2 months following treatment end. Each subject served as his/her own control, comparing results before treatment, and 3 months following treatment end.
  
  
  RESULTS
  Thirty subjects completed the study. A blinded, independent photographs assessment of three dermatologists demonstrated an average reduction of 1.49 Fitzpatrick scores (P < 0.001). Analysis revealed improvement (downgrade of at least 1 score) in almost all subjects. No unexpected adverse events were reported. Post-treatment erythema was seen in all subjects and disappeared within 1 h. In some subjects, post-treatment edema was detected and resolved within 24 h. High satisfaction with the device operation, ease of treatments, safety, and wrinkle reduction was reported.
  
  
  CONCLUSIONS
  The Silk'n Home Skin Tightening (HST) device offers a safe and effective in-home noninvasive technique to improve the appearance of age-related periorbital wrinkles.
authors.affiliation: Tennessee Clinical Research Center, Nashville, TN, USA.|Gold Skin Care Center, Nashville, TN, USA.
authors.forename: Michael H
authors.initials: MH
authors.lastname: Gold
authors.affiliation: Tennessee Clinical Research Center, Nashville, TN, USA.
authors.forename: Julie
authors.initials: J
authors.lastname: Biron
authors.affiliation: Home Skinovations Ltd., Yokneam, Israel.
authors.forename: Liora
authors.initials: L
authors.lastname: Levi
authors.affiliation: Tennessee Clinical Research Center, Nashville, TN, USA.
authors.forename: Whitney
authors.initials: W
authors.lastname: Sensing
mesh_terms: D000328:Adult; D003357:Cosmetic Techniques / Q000009:adverse effects / Q000295:instrumentation; D004487:Edema / Q000209:etiology*; D004890:Erythema / Q000209:etiology*; D005123:Eye; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D017060:Patient Satisfaction; D010781:Photography; D010789:Phototherapy / Q000009:adverse effects / Q000295:instrumentation; D011446:Prospective Studies; D011846:Radio Waves / Q000009:adverse effects; D000078702:Radiofrequency Therapy; D012060:Rejuvenation; D012648:Self Care; D016037:Single-Blind Method; D015595:Skin Aging / Q000528:radiation effects*; D011795:Surveys and Questionnaires
keywords: aging skin; periorbital wrinkles; radiofrequency