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Ulthera® System for Treating Axillary Hyperhidrosis

NCT02286765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-12-14

No results posted yet for this study

Summary

Up to 20 enrolled subjects will be treated. Subjects will receive two Ulthera® treatments on the axillas provided 30 days apart. Follow-up visits will occur at 7, 30, 90 and 180 days following the last treatment.

Protocol amendment: The study was expanded to enroll an additional 20 subjects into Group A.

Conditions

  • Primary Axillary Hyperhidrosis

Interventions

DEVICE

Ulthera System treatment

Micro-focused ultrasound energy delivered below the surface of the skin

Sponsors & Collaborators

  • Ulthera, Inc

    lead INDUSTRY

Principal Investigators

  • Kari Larson, MBA · Ulthera, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-06-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286765 on ClinicalTrials.gov