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

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ClinicalTrials.gov Identifier: NCT01722461
Recruitment Status : Terminated (Sponsor decision; unexpectedly high sham response at primary outcome time point.)
First Posted : November 6, 2012
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Tracking Information
First Submitted Date  ICMJE November 2, 2012
First Posted Date  ICMJE November 6, 2012
Last Update Posted Date November 24, 2017
Study Start Date  ICMJE November 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating [ Time Frame: 30 days post-treatment #2 ]
As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2012)
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating [ Time Frame: 30 days post-treatment #2 ]
As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life quesionnaire
Change History Complete list of historical versions of study NCT01722461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2012)
  • Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating [ Time Frame: 6 month post treatment #2 ]
    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 ]
    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 ]
    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 ]
    As measured by gravimetric method
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Axillary Hyperhidrosis
Intervention  ICMJE
  • Device: Ulthera System
    Focused ultrasound energy delivered below the surface of the skin
    Other Name: Ultherapy™
  • Device: Sham treatment
    Ulthera System delivering no ultrasound energy
Study Arms  ICMJE
  • Experimental: Active treatment
    Ulthera System treatment
    Intervention: Device: Ulthera System
  • Sham Comparator: Sham treatment
    Ulthera System delivering no ultrasound energy
    Intervention: Device: Sham treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 2, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01722461
Other Study ID Numbers  ICMJE ULT-119
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz North America, Inc. ( Ulthera, Inc )
Study Sponsor  ICMJE Ulthera, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark S Nestor, M.D., Ph.D The Center for Clinical and Cosmetic Research
PRS Account Merz North America, Inc.
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP