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19
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.
•
Slight Redness
– This was reported by 1 subject.
•
Mild Stinging Sensation
– Five subjects reported mild discomfort following treatment.
•
In-growing Hair
– One subject reported experiencing an in-growing hair following treatment.
•
Follicle Redness
– One subject reported a red spot at the treatment site following treatment.
In all cases, the treated skin returned to normal within 7 days.
IN VERY RARE CASES
HOW TO ASSESS AND REACT
Swelling and redness that does not disappear within two to
three days.
Stop using the device immediately and consult your
physician before using it again.
Temporary changes in skin colour (lightening or darkening).
If your skin colour changes, stop using the device immediately
and consult your physician.
Blistering or burning of the skin.
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 THE SMOOTHSKIN BARE+
The SmoothSkin Bare+ 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+. The key features of the clinical trial were:
•
All treatments were performed by non-medically trained operators at a single location using devices identical to the SmoothSkin Bare+
provided in this package.
•
All subjects were required to complete questionnaires related to their general health and those who 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.
•
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 the SmoothSkin Bare+.
•
Each subject received 12 weekly treatments to their chosen body location. A typical treatment consisted of shaving the site then applying the
SmoothSkin Bare+ following the same process as outlined in Section 7, 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.
