Smoothskin Bare Fit Guia Del Usuario página 17

5. BENEFITS OF USING SMOOTHSKIN BARE FIT
The SmoothSkin Bare Fit is indicated for the permanent reduction of unwanted hair.
A clinical trial was performed to assess both the safety and efficacy of the SmoothSkin Bare Fit. The key
features of the clinical trial were:
All treatments were performed by non-medically trained operators at a single location using
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devices identical to the SmoothSkin Bare Fit provided in this package;
All subjects were required to complete questionnaires related to their general health and those who
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could not be treated, e.g. those who had one or more of the contraindications as listed in Section 3 of
this User Manual were excluded. In addition, all subjects were required to provide Informed Consent
as per international clinical trial requirements;
A total of 53 female subjects, aged between 19 and 45 years old, commenced the trial;
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Three subjects left the trial during the treatment period for personal reasons. No subjects left the trial
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due to problems associated with the use of the SmoothSkin Bare Fit;
Each subject received 12 weekly treatments to their chosen body location. A typical treatment
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consisted of shaving the site then applying the SmoothSkin Bare 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
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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;
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