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Clinical testing was conducted in both a controlled
practitioner setting and a home-use setting to
confirm that Zeno
treatment is as safe and effective as predicate
devices.
The subjects were enrolled and completed a clinical
study to determine safety and efficacy. This was
a randomized, controlled double-blind study. Each
subject had two similar acne blemishes selected
and the blemishes were randomized for treatment
with Zeno or a placebo device. Each blemish received
a total of three treatments of 2½ minutes
each. Blemishes were assessed by the physician
investigator prior to each treatment and again
on Day 5. Subjects were given a diary to complete
for the assessment of their selected blemishes
every morning and evening until resolution or
Day 14.
Blemishes that were treated with Zeno resolved at a faster rate than those treated with the placebo device. Zeno-treated blemishes resolved on the average of 53.7 hours (2.3 days) faster than those treated with the placebo device. Additionally, blemishes treated with Zeno showed improvement approximately 30.8 hours (1.3 days) more quickly than those treated with the placebo device. When results for resolution or improvement are combined, subjects reported that Zeno-treated blemishes resolved and resolved or improved significantly faster than their clinically matched placebo-treated blemishes.
96% of the blemishes
treated with Zeno achieved resolution or improvement
within 48 hours versus 63% of the placebo-treated
blemishes. 100% of the blemishes treated with
Zeno achieved resolution or improvement within
72 hours versus 75% of the placebo-treated blemishes.
A home use study was conducted with 16 subjects
between the ages of 12 and 70 that presented with
at least one acne blemish. Subjects were not instructed
in the use of Zeno and were dispensed a Zeno,
the Product Manual and Quick Start Guide to take
home and begin self-treating their study blemish(es)
until the blemish(es) resolved or until Day 7,
whichever occurred earlier. Subjects were allowed
to self-treat additional blemish(es). At the end
of the study subjects' understanding was assessed
by completion of a Subject Understanding Survey.
In general, all subjects reported a good understanding
of the device. All subjects agreed or strongly
agreed that they understood the data information
panel and the labeled warnings and precautions.
All subjects strongly agreed that they were confident
that they could use Zeno without supervision by
a doctor.
Acne heat treatment.
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Please visit us again soon to find more Zeno product information and updated clinical findings on ClearPoint™ Technology.
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