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

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

Official Title: Feasibility Study: A Prospective, Parallel, Randomized, Sham-controlled, Blinded Pilot Trial of the Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hype

Brief Summary: Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™ treatment will have a greater reduction in axillary sweating compared to subjects receiving Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at 7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will be completed to compare the amount of axillary sweating compared to baseline.

Detailed Summary:

This study is a prospective, single-center, randomized, sham-controlled, blinded pilot clinical trial. Subjects will be randomly assigned to one of two treatment groups in a 2:1 randomization scheme, two (2) subjects assigned to receive Ultherapy™ treatment to every one subject assigned to receive Sham treatment.

Gravimetric measurement of sweat production and starch iodine tests will be performed, and Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained, prior to treatment and at each follow-up visit. Patient satisfaction will also be assessed. Sham treated subjects will have the option of continuing to Stage II and receive active treatment after completion of their Stage I 90 day study visit.

In a protocol amendment, the initial Stage I study cohort, excluding Sham treated subjects who opt to continue to Stage II, will be recruited to complete one long-term follow-up visit at 365 days following subjects' second study treatment. The same follow-up assessments will be completed to compare the amount of axillary sweating compared to baseline.


Sponsor: Ulthera, Inc

Current Primary Outcome: Percentage of subjects with HDSS scores of 1 or 2 [ Time Frame: 30 days post-treatment #2 ]

The HDSS scale is a qualitative measure of the severity of the condition based on how it affects subjects' daily activities. Subjects select the statement that best reflects their experience with underarm sweating on a 4 point scale, with 1 = sweating never noticeable and 4 = sweating is intolerable.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction in spontaneous axillary sweat production [ Time Frame: Participants will be followed to 365 days post treatment #2 ]
    Assessed by a gravimetric method as measured by a 50% reduction or more compared to baseline.
  • Subject Satisfaction [ Time Frame: Participants will be followed to 365 days post-treatment #2 ]
    Subject satisfaction will be measured using a Patient Satisfaction Questionnaire (PSQ.)


Original Secondary Outcome: Same as current

Information By: Ulthera, Inc

Dates:
Date Received: October 22, 2012
Date Started: December 2011
Date Completion:
Last Updated: June 28, 2013
Last Verified: June 2013