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Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days post-treatment #2.
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