Feasibility Study: Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|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 Hyperhidrosis|
- Percentage of subjects with HDSS scores of 1 or 2 [ Time Frame: 30 days post-treatment #2 ] [ Designated as safety issue: No ]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.
- Reduction in spontaneous axillary sweat production [ Time Frame: Participants will be followed to 365 days post treatment #2 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Subject satisfaction will be measured using a Patient Satisfaction Questionnaire (PSQ.)
|Study Start Date:||December 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Active Treatment
Subjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings.
Drug: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
Sham Comparator: Sham Treatment
Subjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules.
Drug: Sham treatment
Study treatment using the Ulthera System, but delivering no ultrasound energy.
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.
|United States, Florida|
|The Center for Clinical and Cosmetic Research|
|Aventura, Florida, United States, 33180|
|Principal Investigator:||Mark Nestor, MD, PhD||The Center for Clinical and Cosmetic Research|