Previously, nonablative laser treatment of periorbital and perioral rhytids could
only be performed in an office setting by trained medical professionals. The efficacy
of an FDA-cleared nonablative 1440-nm laser device designed for consumer home-use
treatment of periorbital and perioral rhytids was evaluated in a 22-week study under
nurse treatment conditions. Fifty-eight healthy female panelists, ages 40-70 years,
Fitzpatrick skin type I-IV, provided informed consent to participate in this evaluator-blinded
IRB-approved study. Panelists were treated on periorbital and perioral sites by nurses,
5×/wk over the course of 12 weeks. Initially, the high setting of the device was used
for all treatments. 24-hour posttreatment, the treating nurses evaluated clinical
irritation (if any), and would move to the low setting or skip a treatment if warranted.
After the initial 12 week period a randomly selected subset (N = 20) continued on
a 2×/wk maintenance regimen for a further 4 weeks. All panelists were evaluated in-person
by an independent dermatologist using the validated 0-9 Fitzpatrick Wrinkle Scale
(FWS, ½ point increments allowed), and separate evaluation was performed with digital
photos, 3D evaluation of texture (Primos), and panelist surveys at baseline and after
4, 8, 12, and 16 (maintenance) weeks of treatment as well as a 6 weeks follow up after
the last treatment (no treatment regression). Treatments were well tolerated, with
38 panelists receiving the majority of treatments using the high setting of the device
and good protocol compliance to the total number of treatments. The most common side
effect was mild erythema, with an occurrence rate of only 0.57%. Independent blinded
dermatologist assessment of photodamage showed significant reduction to periorbital
lines and wrinkles by 2 weeks of treatment, and by week 12 for the perioral site.
After 12 weeks of treatment 93.1% and 60.3% of subjects showed improvement in the
periorbital and perioral sites, respectively (mean FWS reduction
P < .05 of 1.22 ± 0.09, 0.34 ± 0.08). In the maintenance group, these benefits were maintained
after 2×/wk treatment, and similarly efficacy was maintained in both maintenance and
nonmaintenance groups in follow up evaluations 6 weeks after the last treatment. Panelist
surveys confirmed the benefits to lines and wrinkles observed clinically. The results
of this study showed good tolerance and efficacy for treating periorbital and perioral
wrinkles with the 1440nm home-use device.
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© 2014 Published by Elsevier Inc.