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

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.

Study Overview

• Status: Terminated
• Conditions: Primary Axillary Hyperhidrosis
• Intervention / Treatment: Device: Ulthera System; Device: Sham treatment

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Roseville, California, United States, 95661
      • Roseville Facial Plastic Surgery
  • Florida
    • Aventura, Florida, United States, 33180
      • The Center for Clinical and Cosmetic Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Few Institute of Aesthetic Plastic Surgery
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • St Louis University Dermatology
  • New York
    • New York, New York, United States, 10021
      • Day Dermatology & Aesthetics
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female, age 18 years or older.
• Subject is in good health.
• Diagnosis of primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria.
• At least 50mg at 5 min of spontaneous resting axillary sweat production in each axilla measured gravimetrically
• A HDSS score of 3 or 4
• Willingness to comply with study visits and requirements
• Female subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1
• Female subjects over 40 years of age must have had a mammogram in the last 2 years

Exclusion Criteria:

• Has a dermal disorder including infection at anticipated treatment sites in either axilla.
• Has had axillary injections of botulinum toxin in the last year.
• Has an expected use of botulinum toxin for the treatment of any other disease during the study period.
• Has a known allergy to starch powder, iodine, or lidocaine.
• Has secondary hyperhidrosis
• Has had previous surgical treatment of hyperhidrosis
• Has had prior miraDry treatment for axillary hyperhidrosis.
• Has used prescription antiperspirants in the last 14 days or plans to use them during the study period.
• Inability to withhold use of non-study-supplied antiperspirants and deodorants
• Unwillingness to wash off study-supplied antiperspirants and abstain from use for 72 hours prior to treatments or assessments.
• History of previous Ultherapy™ treatment to the axilla.
• Has a history of a bleeding disorder
• Has used of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis in the past 4 weeks.
• Is a prisoner or under incarceration.
• Is participating in another clinical trial involving the use of investigational devices or drugs (or has in the last 30 days.)
• Has a history of cancer (some exceptions), lymphectomy, or a planned lymphectomy.
• Has a pacemaker or other electronic implant.
• Requires supplemental oxygen.
• Has used antiplatelet agents / Anticoagulants (Coumadin, Pradaxa, Heparin, Plavix) in the past 6 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active treatment; Ulthera System treatment	Device: Ulthera System; Focused ultrasound energy delivered below the surface of the skin; Other Names: Ultherapy™
SHAM_COMPARATOR: Sham treatment; Ulthera System delivering no ultrasound energy	Device: Sham treatment; Ulthera System delivering no ultrasound energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating	As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire	30 days post-treatment #2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating	As measured by the HDSS	6 month post treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating	As measured by the HDSS	12 months post treatment #2
Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production	As measured by gravimetric method	3 months post treatment
Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production	As measured by gravimetric method	Subjects will be followed to 12 months post treatment #2

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Mark S Nestor, M.D., Ph.D, The Center for Clinical and Cosmetic Research

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: November 2, 2012
• First Submitted That Met QC Criteria: November 2, 2012
• First Posted (ESTIMATE): November 6, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Excessive underarm sweating
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: ULT-119