Histological Analysis Following Ulthera System Treatment for Hyperhidrosis

Hyperhidrosis Clinical Trial

Official title: Histological Analysis and Correlation With Ultrasound Imaging to Evaluate the Safety and Effectiveness of Treating Axillary Hyperhidrosis Subjects With the Ulthera® System

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This study is a prospective, single-center, non-randomized pilot clinical trial. Subjects enrolled will include:

• those naïve to Ultherapy™ for treatment of hyperhidrosis (Group A, n=31); dual-depth treatment at 4.5mm and 3.0mm;

• those who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis (Group B, n=approx 5), dual-depth treatment at 4.5mm and 3.0mm;

• those naïve to Ultherapy™ for treatment of hyperhidrosis who will receive one double-density study treatment (Group C, n=4), dual-depth treatment at 4.5mm and 3.0mm;

• those naïve to Ultherapy™ for treatment of hyperhidrosis (Group D, n=10), single-depth treatment at 2.0mm at standard energy;

• those naïve to Ultherapy™ for treatment of hyperhidrosis (Group E, n=10), single-depth treatment at 2.0mm at adjusted energy.

• 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.

Ultrasound images will be captured of each axilla to assess dermal thickness and depth of sweat glands. A gravimetric measurement of sweat production and starch iodine test will be performed prior to treatment. Digital images of the starch iodine test will be obtained. Hyperhidrosis Disease Severity Scale (HDSS)scores will be obtained prior to each treatment. During treatment, the average Numeric Rating Scale (NRS) score will be obtained by axilla treated. Efficacy will be determined by a reduction in the number of sweat glands from baseline to 90-days post-treatment, as evidenced by histological analysis. Subject Gravimetric results, Starch iodine results, and HDSS scores at all follow-ups compared to baseline will also be analyzed as secondary outcomes. ;

Related Conditions & MeSH terms

• Hyperhidrosis

• NCT number: NCT01708551
• Study type: Interventional
• Source: Merz North America, Inc.
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Completion date: August 2015