Benefits And Risks - Tria SMOOTHBEAUTY LASER Instructions D'utilisation

BENEFITS AND RISKS

The benefits and risks of the Tria
SmoothBeauty™ Laser were tested in a
clinical study involving 60 participants,
ages 32-70. Participants treated the skin
on their face 5 days a week for 12 weeks
and were evaluated throughout the study
for skin improvement and side effects.
BENEFITS
Based on the clinical study, Treatment
Levels 2 and 3 were shown to significantly
improve periorbital wrinkles for most
participants. Better results were obtained
when using Treatment Level 3. Improvements
were determined by doctors who graded
the fine lines and wrinkles around the eyes
using photographs and who did not know
which photographs were before or after
treatment. Improvement was defined as at
least a 1-point change on a 9-point scale,
as judged by at least 2 of the 3 grading
doctors. Participants also evaluated their
own level of improvement.
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Four weeks after the last treatment, 45 of
60 participants (75%) had improvement
in periorbital wrinkles. Twelve weeks after
the last treatment, 37 of 60 participants
(62%) had improvement in periorbital
wrinkles. Please note that the observed
improvement could be in part due to
other non-device-specific effects. Based
on subject satisfaction results, 36 of 47
participants (77%) noted improvement in
their periorbital wrinkles 4 weeks after
the last treatment and 41 of 55 participants
(75%) noted improvement in their periorbital
wrinkles 12 weeks after the last treatment.
Your results may vary because of how
you use your Tria SmoothBeauty™ Laser or
how your skin responds to treatment.
RISKS
The side effects that appeared most
frequently after treatment in the clinical
trial included: redness (57 of 60 subjects),
stinging or prickling sensation (55 of 60
subjects), burning sensation (50 of 60