LB0261 Rev A 01/2018
© Miramar Labs, Inc. 2018, Confidential Information of Miramar Labs, Inc.
Page 9
7.
CLINICAL DATA
The ability of the miraDry System to treat axillary hyperhidrosis has been studied in two separate
clinical studies that utilized earlier versions of the miraDry System. A study using the
most current miraDry System has been completed to measure the amount of underarm hair
reduction.
7.1.
RANDOMIZED, BLINDED, MULTICENTER STUDY
Device:
The device used in this study was the DTS G2 System, the predecessor of the miraDry System.
Microwave energy settings that were used with the DTS G2 System were equivalent to
Microwave Energy Setting 1 on the miraDry System.
Study Design:
The study involved two patient groups. In the first group, the subjects received the DTS G2
System procedure with microwave energy treatment for axillary hyperhidrosis in both axillae
(the “treatment group”). The second group of subjects had the same procedure but without
microwave energy applied (the “placebo group”). Subjects were randomized to one of the two
groups with twice as many patients being assigned to the treatment group. Subjects were also
“blinded” as to whether they were to receive the microwave energy or placebo treatment. The
majority of subjects (83%) were treated with two treatment sessions, separated by
approximately 14 days. In all these cases the full hair-bearing area of both axillae were treated
in the first session. The second session was used to “touch-up” any remaining areas of active
sweat. Another 9% of subjects only received one treatment session, and the remaining 8% of
subjects had 3 treatment sessions.
All subjects had follow up assessments at 14 days, 30 days, 3 months and 6 months following
their final treatment session. At 6 months, the subjects were unblinded as to their group
assignment. Placebo group subjects exited the study while treatment group subjects remained
in the study and had additional follow-up visits at 9 months and 12 months following their final
treatment session.
Subjects:
One hundred and twenty (120) adult subjects enrolled in the study. Eighty-one (81) subjects
were randomized to the treatment group and thirty-nine (39) subjects were randomized to the
placebo group. The mean age of subjects was 32.8 years and 58% of the subjects were
female. Eighty-four percent (84%) of the subjects were “White”, 6.7% were “African American”,
and the rest were categorized as “Other”. The majority of subjects were of Fitzpatrick skin type
III, but the study also included subjects with skin types I-V. There were no subjects enrolled that
had skin type VI.
Results:
The study primary endpoint compared the Hyperhidrosis Disease Severity Scale (HDSS)
quality of life success rate of the treatment group to the placebo group based on data collected
at the 30-day follow-up visit. Success was defined as moving from a pre-treatment baseline
score of 3 or 4 to a post-treatment score of 1 or 2. Last-observation-carry-forward was used to
impute missing data. Overall, 89% of the treatment group had success versus 54% for the
placebo group (p<0.001).
In addition, the 81 treatment group subjects showed good long-term efficacy with 69.1% of
these subjects having HDSS success at their final study visit.