NCT01713959

Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis

Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperhidrosis

Interventions

Type	Name	Description
DEVICE	Ulthera System treatment	Ulthera System: Focused ultrasound energy delivered below the surface of the skin.
DEVICE	Sham treatment	Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-04-01
• Completion: 2012-06-01
• First posted: 2012-10-25
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States