Multicenter clinical trial of a home-use nonablative fractional laser device for wrinkle reduction

J Am Acad Dermatol. 2012 Nov;67(5):975-84. doi: 10.1016/j.jaad.2012.01.041. Epub 2012 Mar 3.

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.

Limitations: Lack of a control group and single-blinded study groups were limitations.

Conclusion: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Ambulatory Care
  • Clinical Protocols
  • Cosmetic Techniques / instrumentation*
  • Equipment Design
  • Female
  • Humans
  • Laser Therapy / instrumentation*
  • Male
  • Middle Aged
  • Rejuvenation
  • Skin Aging / radiation effects*
  • Wound Healing