CyDen SMOOTHSKIN Bare Fit Manual Del Usuario página 9

IN VERY RARE CASES
Swelling and redness that does not disappear within two to three days.
Temporary changes in skin colour (lightening or darkening).
Blistering, scarring or burning of the skin.
In a clinical trial of 50 subjects, each subject received 12 weekly treatments. The recorded effects
were:
Itchiness – Four subjects experienced mild itchiness after treatment.
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Slight Redness – This was reported by 1 subject.
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Mild Stinging Sensation – Five subjects reported mild discomfort following treatment.
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In-growing Hair – One subject reported experiencing an in-growing hair following treatment.
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Follicle Redness – One subject reported a red spot at the treatment site following treatment.
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In all cases, the treated skin returned to normal within 7 days.
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HOW TO ASSESS AND REACT
Stop using the device immediately and consult your physician
before using it again.
If your skin colour changes, stop using the device immediately and
consult your physician.
Stop using the device immediately and consult your physician before
using it again. Apply a cold pack to the area. Treat with antiseptic or
burn cream.
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
•
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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