NCT01722461

A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis

A Prospective, Multi-Center, Parallel, Randomized, Double-Blinded Study of the Efficacy and Safety of the Ulthera® System for the Treatment of Primary Axillary Hyperhidrosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to deliver no ultrasound energy. Subjects will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart. Subjects and study personnel conducting efficacy measures will be blinded to the assigned treatment groups. The study hypothesis is that subjects in the active treatment group will have a greater reduction in underarm sweating compared to those in the sham group as measured by a quality of life questionnaire. All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their second study treatment. Subjects in the active treatment group will also undergo follow-up assessments at 9 months and 12 months from the date of their second study treatment.

Conditions

• Primary Axillary Hyperhidrosis

Interventions

Type	Name	Description
DEVICE	Ulthera System	Focused ultrasound energy delivered below the surface of the skin
DEVICE	Sham treatment	Ulthera System delivering no ultrasound energy

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-05-01
• Completion: 2013-11-01
• First posted: 2012-11-06
• Last updated: 2017-11-24

Locations

6 sites across 1 country: United States