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| Study Details |
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The TRIA study
was designed to validate the safety and efficacy
of the device. Additionally, it was designed to
demonstrate a low and appropriate rate of side
effects in suitable users.
Usability data, physical
hair counts and side effects were collected at
each treatment visit and at 1 month, 2 month,
and 3 month follow-up visits following the 3rd
treatment. 77 subjects completed the study and
reported the following results: |
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| Hair Count
Reduction |
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3 weeks after 1st treatment: 61% mean
hair count reduction from all sites |
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3 weeks after 2nd treatment: 70% mean
hair count reduction from all sites |
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4 weeks after 3rd treatment: 60% mean
hair count reduction from all sites |
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| In addition, these subjects
noted skin textural improvements compared to
their usual method of hair removal. |
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43% reported that TRIA produced
"smoother skin" |
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38% of subjects reported that TRIA
produced "less skin irritation and
bumps" |
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20% reported that TRIA produced
"softer skin" |
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Overall
Satisfaction
After the first treatment, 45% of
the study participants reported they were
"satisfied" with their results, 25% reported
they were "very satisfied" with their results
and 17% reported that they were "extremely
satisfied."
Just four weeks after the
third treatment, the number of "very satisfied"
participants increased to 32% and "extremely
satisfied" participants increased to 42%.
Overall, 100% of study participants rated their
results as satisfactory or better after the
third treatment. |
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Re-Growth
At the one month follow up,
subjects were asked to assess the character of
any hair re-growth: |
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87% of subjects that any hair
re-growth was finer |
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85% of subjects that any hair
re-growth was less noticeable |
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70% of subjects felt that any hair
re-growth was lighter |
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| Study
Participants |
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Study subjects were screened and
enrolled into a sample pool designed to
generally match US national demographics for
race/ethnicity, age, and education, such that
the sample would represent the expected domestic
consumer market of the device. Particular
emphasis was placed on obtaining a wide variety
of skin and hair color combinations since these
characteristics were the primary factors
expected to affect safety and efficacy.
Exclusion criteria included dark brown and black
skin, treatment areas for red, white, gray or
blond hairs, any prior permanent hair removal
treatment and plucking, tweezing, waxing, or
chemical depilatories in the treatment areas
during the study.
The
study was performed at a single-site (University
of Arizona, Health Sciences Center, Department
of Dermatology) and all study subjects were
recruited from the Tucson, AZ area. All
treatments and observations were performed at
the dermatology clinic in a dedicated room
equipped with TRIA devices, its labeling, and
bath supplies, such as a razor and mirror, that
are consistent with treatment recommendations in
the instructions-for-use and typical of a home
environment. |
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