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

NCT01713959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-11-24

No results posted yet for this study

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.

Conditions

  • Hyperhidrosis

Interventions

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.

Sponsors & Collaborators

  • Ulthera, Inc

    lead INDUSTRY

Principal Investigators

  • Mark Nestor, MD, Ph.D · The Center for Clinical & Cosmetic Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-04-30
Completion
2012-06-30

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 NCT01713959 on ClinicalTrials.gov