Format

Send to

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

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

Author information

1
Skin Study Center, Broomall, Pennsylvania 19008, USA. jjleyden@mindspring.com

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.

PMID:
22386051
DOI:
10.1016/j.jaad.2012.01.041
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center