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

Primary Purpose

Primary Axillary Hyperhidrosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera System
Sham treatment
Sponsored by
Ulthera, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Axillary Hyperhidrosis focused on measuring Excessive underarm sweating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roseville Facial Plastic Surgery
  • The Center for Clinical and Cosmetic Research
  • Few Institute of Aesthetic Plastic Surgery
  • St Louis University Dermatology
  • Day Dermatology & Aesthetics
  • Virginia Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active treatment

Sham treatment

Arm Description

Ulthera System treatment

Ulthera System delivering no ultrasound energy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
As measured by the HDSS
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
As measured by the HDSS
Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production
As measured by gravimetric method
Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production
As measured by gravimetric method

Full Information

First Posted
November 2, 2012
Last Updated
November 21, 2017
Sponsor
Ulthera, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01722461
Brief Title
A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision; unexpectedly high sham response at primary outcome time point.
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Axillary Hyperhidrosis
Keywords
Excessive underarm sweating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active treatment
Arm Type
Experimental
Arm Description
Ulthera System treatment
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
Ulthera System delivering no ultrasound energy
Intervention Type
Device
Intervention Name(s)
Ulthera System
Other Intervention Name(s)
Ultherapy™
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Intervention Type
Device
Intervention Name(s)
Sham treatment
Intervention Description
Ulthera System delivering no ultrasound energy
Primary Outcome Measure Information:
Title
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
Description
As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire
Time Frame
30 days post-treatment #2
Secondary Outcome Measure Information:
Title
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
Description
As measured by the HDSS
Time Frame
6 month post treatment #2
Title
Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
Description
As measured by the HDSS
Time Frame
12 months post treatment #2
Title
Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production
Description
As measured by gravimetric method
Time Frame
3 months post treatment
Title
Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production
Description
As measured by gravimetric method
Time Frame
Subjects will be followed to 12 months post treatment #2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Nestor, M.D., Ph.D
Organizational Affiliation
The Center for Clinical and Cosmetic Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roseville Facial Plastic Surgery
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
The Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Few Institute of Aesthetic Plastic Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St Louis University Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Day Dermatology & Aesthetics
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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