Smoothskin PURE FIT Manual Del Usuario página 10

A total of 53 female subjects, aged between 19 and 45 years old, commenced the trial;
Three subjects left the trial during the treatment period for personal reasons. No subjects left the trial
due to problems associated with the use of SmoothSkin Pure Fit;
Each subject received 12 weekly treatments to their chosen body location. A typical treatment consisted
of shaving the site then applying SmoothSkin Pure Fit following the same process as outlined in Section
8, Step 3 of this user manual;
Hair counts were used to measure the change in the amount of hair 6 months after the last treatment
and 12 months after the last treatment. The hairs in the treatment sites were counted via high resolution
photography and the difference in hair counts was calculated as a percentage change;
When used as directed, the clinical trial participants showed on average 44% less hair 6 months after
their last treatment and 36% less hair 12 months after their last treatment when compared to hair counts
taken before treatment (See Table below). Actual results did vary from person to person;
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Number of Subjects at 6 Months Post Treatment.
Hair Reduction at 6 Months Post Treatment.
Number of Subjects at 12 Months Post Treatment.
Hair Reduction at 12 Months Post Treatment.
% of Subjects met success (>30% hair reduction) on all
body areas at 12 months post-treatment. Subject Success is
defined as greater than 30% hair reduction at all treatment
sites at 12 months.
The incidence of side effects during the clinical trial was minimal (as outlined in Section 4 above) and
the majority of subjects (48 out of 50) would recommend SmoothSkin Pure Fit to their friends.
SMOOTHSKIN PURE
50
43.9%
33
36.0%
66.7%
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