title: Multicenter clinical trial of a home-use nonablative fractional laser device for wrinkle reduction.
abstract: BACKGROUND
  Until now, nonablative fractional treatments could only be delivered in an office setting by trained professionals.
  
  
  OBJECTIVE
  The goal of this work was to perform clinical testing of a nonablative fractional laser device designed for home-use.
  
  
  METHODS
  This multicenter trial consisted of two clinical studies with slightly varying treatment protocols in which subjects performed at-home treatments of periorbital wrinkles using a handheld nonablative fractional laser. Both studies included an active treatment phase (daily treatments) and a maintenance phase (twice-weekly treatments). In all, 36 subjects were followed up for as long as 5 months after completion of the maintenance phase and 90 subjects were followed up until the completion of the maintenance phase. Evaluations included in-person investigator assessment, independent blinded review of high-resolution images using the Fitzpatrick Wrinkle Scale, and subject self-assessment.
  
  
  RESULTS
  All 124 subjects who completed the study were able to use the device following written instructions for use. Treatments were well tolerated with good protocol compliance. Independent blinded evaluations by a panel of physicians showed Fitzpatrick Wrinkle Scale score improvement by one or more grades in 90% of subjects at the completion of the active phase and in 79% of subjects at the completion of the maintenance phase. The most prevalent side effect was transient posttreatment erythema.
  
  
  CONCLUSIONS
  Lack of a control group and single-blinded study groups were limitations.
  
  
  CONCLUSIONS
  Safety testing with self-applications by users demonstrated the utility of the device for home use. Independent blinded review of clinical images confirmed the device's proficiency for improving periorbital wrinkles.
authors.affiliation: Skin Study Center, Broomall, Pennsylvania 19008, USA. jjleyden@mindspring.com
authors.forename: James
authors.initials: J
authors.lastname: Leyden
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Stephens
authors.forename: James H
authors.initials: JH
authors.lastname: Herndon
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D002985:Clinical Protocols; D003357:Cosmetic Techniques / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D053685:Laser Therapy / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D012060:Rejuvenation; D015595:Skin Aging / Q000528:radiation effects*; D014945:Wound Healing