Clinical Trial: Histological Analysis Following Ulthera System Treatment for Hyperhidrosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Histological Analysis and Correlation With Ultrasound Imaging to Evaluate the Safety and Effectiveness of Treating Axillary Hyperhidrosis Subjects With the Ulthera® S

Brief 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 Summary:

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 e
Sponsor: Ulthera, Inc

Current Primary Outcome: Reduction in the number of sweat glands from baseline to 90-days post-treatment. [ Time Frame: 90 days post-treatment ]

Based on histological analyses of biopsied, Ultherapy™-treated, tissue, the changed in the number of sweat glands present at 90days post-treatment will be compared to the number of sweat glands present at baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment [ Time Frame: 7 days post-treatment ]
    A 50% reduction or more in Gravimetric measure at 7 days post-treatment compared to baseline.
  • Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment [ Time Frame: 30 days post-treatment ]
    A 50% reduction or more in Gravimetric measure at 30 days post-treatment compared to baseline.
  • Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment [ Time Frame: 90 days post-treatment ]
    A 50% reduction or more in Gravimetric measure at 90 days post-treatment compared to baseline.
  • Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment [ Time Frame: 180 days post-treatment ]
    A 50% reduction or more in Gravimetric measure at 180 days post-treatment compared to baseline.
  • HDSS score reduction [ Time Frame: 90 days post-treatment ]
    HDSS score reduction from a 3 or 4 to a 1 or 2
  • Starch iodine test [ Time Frame: 90 days post-treatment ]
    Assess the reduction in starch iodine test area at 90 days post-treatment compared to baseline.


Original Secondary Outcome:

  • Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment [ Time Frame: 90 days post-treatment ]
    A 50% reduction or more in Gravimetric measure at 90 days post-treatment compared to baseline.
  • HDSS score reduction [ Time Frame: 90 days post-treatment ]
    HDSS score reduction from a 3 or 4 to a 1 or 2
  • Starch iodine test [ Time Frame: 90 days post-treatment ]
    Assess the reduction in starch iodine test area at 90 days post-treatment compared to baseline.


Information By: Ulthera, Inc

Dates:
Date Received: October 15, 2012
Date Started: August 2012
Date Completion:
Last Updated: October 7, 2015
Last Verified: October 2015