Hyperhidrosis Clinical Trial
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
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.
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.
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