In-growing Hair – 1 subject reported experiencing an in-growing hair following treatment.
•
Follicle Redness – 1 subject reported a red spot at the treatment site following treatment.
•
In all cases, the treated skin returned to normal within 7 days.
5. BENEFITS OF USING SMOOTHSKIN PURE
SmoothSkin Pure Fit is indicated for the permanent reduction of unwanted hair.
A clinical trial was performed to assess both the safety and efficacy of SmoothSkin Pure Fit. 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 SmoothSkin Pure Fit 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 SmoothSkin Pure Fit;
Each subject received 12 weekly treatments to their chosen body location. A typical treatment consisted
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