Clinical Trial: Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis

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

Official Title: Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis

Brief Summary: Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at 7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2.

Detailed Summary:

Subjects will be randomized to one of two study groups:

  • Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other axilla.
  • Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine injection administered to one axillary side.

Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be obtained at all study visits. Patient satisfaction questionnaires will also be obtained at 30, 60 and 90 days post-treatment #2.


Sponsor: Ulthera, Inc

Current Primary Outcome: Improvement in sweat production [ Time Frame: 90-days post-treatment treatment #2 ]

Axillary hyperhidrosis as assessed by using a gravimetric method.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in sweat production at follow-up timepoints other than 90 days post-treatment [ Time Frame: Participants will be followed up to 60 days post-treatment ]
    Axillary hyperhidrosis as assessed by using a gravimetric method.
  • Area of efficacy [ Time Frame: Participants will be followed for up to 90 days following treatment #2. ]
    Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained.
  • Qualitative measure of hyperhidrosis severity [ Time Frame: Participants will be followed for up to 90 days following treatment #2 ]
    The HDSS is a scale used for primary axillary/underarm hyperhidrosis patients. It provides a qualitative measure of the severity of their condition based on how it affects their daily activities. Patients select the statement that best reflects their experience with underarm sweating.


Original Secondary Outcome: Same as current

Information By: Ulthera, Inc

Dates:
Date Received: October 15, 2012
Date Started: August 2011
Date Completion:
Last Updated: June 27, 2013
Last Verified: June 2013