linical trial
of
50 subjects, each subj~ct rec~ived
12
weekly treatments. The recorded
effects
were:
In
a c . . F r
subJ
'ects experienced mild itchiness
after
treatment.
• Itchiness. ou 1 b' t
•
Sli
ht Redness: This was
~porte~
by
su
Jec
. .
• M'~ Stinging Sensation: Five subJects
repo~ed
mild
dlscomfo~
following treatment.
• ln~growing Hair: One subj~ct reported experiencing
an
In-growing h~ir following treatment .
• Follicle Redness: One subJect reported
8
red
spot
8t
th
e treatment
Site
following treatment.
In
all
cases,
the
t
reated skin returned
to
normal within 7 days.
5 Benefits
Toe
device
is
indicated for the permanent reduction
of
unwanted hair.
A clinical trial was performed
to
assess
both
the
safety and efficacy
of
the
device. 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 one 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
tr
ial
due
to
problems associated with the use
of
the
device;
•
Each
subject received
12
weekly treatments
to
their chosen body location. A typical
treatment
consisted
of shaving the site then applying
the
device following the same process as outlined in
Sec
tion 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
resoluti
on
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.
Number
of
subjects at 6 months
post
treatment
50
Hair
reduction
at
6
months
post treatment
43.9
%
Number
of
subjects
at
12
months
post
treatment
33
Hair
reduction at
12
months
post
treatment
36
.
0%
% of subjects
met
success(
> 30% hair reduction) on all body areas
at
12
months
66.7 %
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 the device
to
their friends.
6 Intended
Use
of
Silk-expert
USE
The
device is intended
for
the permanent reduction in unwanted, visible hair
for
a single
user
.
BODY
AREAS
Women:
legs,
arms, underarms, bikini area and face (below the cheek bones) .
CAUTION:
Do
not
use
the
device
near
the
eyes,
along
the
forehead,
on
the
lips
or
nostrils.
Do
not
use
it
in
the
genital
area.
Men:
h I )
CAUTION·.
Shoulders and below (chest, back, arms,
sto~ac
' egs
Do
not
use
on
the
face
neck
or
genital
area.
. .
The
device is intended
to
be
~sed on
body
hair below the neck, including arms,
underarms, bikini line, stomach and legs.
9
To Next Page
Loading...
