Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Sponsor decision; unexpectedly high sham response at primary outcome time point.)
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01722461
First received: November 2, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Primary Axillary Hyperhidrosis
Device: Ulthera System
Device: Sham treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating [ Time Frame: 30 days post-treatment #2 ] [ Designated as safety issue: No ]
    As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire


Secondary Outcome Measures:
  • Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating [ Time Frame: 6 month post treatment #2 ] [ Designated as safety issue: No ]
    As measured by the HDSS

  • Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating [ Time Frame: 12 months post treatment #2 ] [ Designated as safety issue: No ]
    As measured by the HDSS

  • Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production [ Time Frame: 3 months post treatment ] [ Designated as safety issue: No ]
    As measured by gravimetric method

  • Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production [ Time Frame: Subjects will be followed to 12 months post treatment #2 ] [ Designated as safety issue: No ]
    As measured by gravimetric method


Enrollment: 120
Study Start Date: November 2012
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active treatment
Ulthera System treatment
Device: Ulthera System
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
Sham Comparator: Sham treatment
Ulthera System delivering no ultrasound energy
Device: Sham treatment
Ulthera System delivering no ultrasound energy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722461

Locations
United States, California
Roseville Facial Plastic Surgery
Roseville, California, United States, 95661
United States, Florida
The Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
United States, Illinois
Few Institute of Aesthetic Plastic Surgery
Chicago, Illinois, United States, 60611
United States, Missouri
St Louis University Dermatology
St. Louis, Missouri, United States, 63104
United States, New York
Day Dermatology & Aesthetics
New York, New York, United States, 10021
United States, Virginia
Virginia Clinical Research
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Mark S Nestor, M.D., Ph.D The Center for Clinical and Cosmetic Research
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01722461     History of Changes
Other Study ID Numbers: ULT-119
Study First Received: November 2, 2012
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ulthera, Inc:
Excessive underarm sweating

Additional relevant MeSH terms:
Hyperhidrosis
Skin Diseases
Sweat Gland Diseases

ClinicalTrials.gov processed this record on November 24, 2014