Tria SRL - Page 6

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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
subjects) and warmth sensation (47 of 60
subjects). Clinical results show that these
side effects usually resolved within several
minutes or hours after a treatment. When
using the device daily, these side effects
may diminish and resolve before your next
daily treatment, however, depending on
how your skin responds to treatment, some
may not fully resolve before your next
daily treatment. Do not perform another
treatment until all side effects have fully
resolved. In the clinical study, all of these
side effects resolved within 4 weeks after
stopping treatment.
Other side effects reported in the
clinical study included: dry skin (21 of 60
subjects), acne flare (14 of 60 subjects),
headache (4 of 60 subjects), temporary
small brown dots (7 of 60 subjects),
skin sensitivity (8 of 60 subjects), macule
(5 of 60 subjects), skin roughness (3 of 60
subjects), skin tenderness (2 of 60 subjects),
and skin peeling (2 of 60 subjects). Other
side effects that were each reported in
one subject included cold sore, dry lips,
ecchymosis, excoriation, and venodilation.
Not all of these side effects may have been
caused by the device.
Skin darkening that lasted more than
3 months after treatment was reported
in 4 of 60 subjects. If you experience skin
color darkening, you should discontinue
use of the device.
The benefits and risks of the Tria Age-
Defying 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.
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 Age-Defying Laser or how
your skin responds to treatment.
BENEFITS AND RISKS