Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in
      Groups A, B or C will undergo axillary punch biopsies during the course of the trial to
      determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm
      and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A
      and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will
      receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment
      depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol
      amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy
      setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40
      lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days
      post-treatment #2.
    

Detailed description: 
      This study is a prospective, single-center, non-randomized pilot clinical trial. Subjects
      enrolled will include:

        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group A, n=31); dual-depth
           treatment at 4.5mm and 3.0mm;

        -  those who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis (Group
           B, n=approx 5), dual-depth treatment at 4.5mm and 3.0mm;

        -  those naïve to Ultherapy™ for treatment of hyperhidrosis who will receive one
           double-density study treatment (Group C, n=4), dual-depth treatment at 4.5mm and 3.0mm;

        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group D, n=10), single-depth
           treatment at 2.0mm at standard energy;

        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group E, n=10), single-depth
           treatment at 2.0mm at adjusted energy.

        -  Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the
           same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment
           square; Group E, 40 lines per treatment square.

      Ultrasound images will be captured of each axilla to assess dermal thickness and depth of
      sweat glands. A gravimetric measurement of sweat production and starch iodine test will be
      performed prior to treatment. Digital images of the starch iodine test will be obtained.
      Hyperhidrosis Disease Severity Scale (HDSS)scores will be obtained prior to each treatment.
      During treatment, the average Numeric Rating Scale (NRS) score will be obtained by axilla
      treated. Efficacy will be determined by a reduction in the number of sweat glands from
      baseline to 90-days post-treatment, as evidenced by histological analysis. Subject
      Gravimetric results, Starch iodine results, and HDSS scores at all follow-ups compared to
      baseline will also be analyzed as secondary outcomes.
    

Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy™
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperhidrosis; Axillary sweating; Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.