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