search
Back to results

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

Primary Purpose

Hyperhidrosis

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

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring Hyperhidrosis, Axillary sweating, Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female, ages 18-75
  • Subject is in good health
  • Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
  • At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity over a period of 5 minutes
  • A HDSS score is 3 or 4. An attempt will be made to approximate an equal number of scores 3 and 4
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period
  • Absence of physical conditions unacceptable to the investigator
  • Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure
  • Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating

Exclusion Criteria:

  • Dermal disorder including infection at anticipated treatment sites in either axilla
  • Previous botulinum toxin treatment of the axilla in the past year
  • Expected use of botulinum toxin for the treatment of any other disease during the study period
  • Known allergy to starch powder or iodine
  • Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria
  • Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery
  • Unwillingness to wash off deodorants and abstain use 72 hours prior to treatments or assessments
  • History of previous Ultherapy™ treatment to the axilla
  • Subjects with a history of a bleeding disorder
  • Use of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis
  • Inability to withhold use of antiperspirants and deodorants, or any other topical treatments for hyperhidrosis within 72 hours prior to study treatments and assessments
  • Unwillingness for complete shaving or removal of underarm hair within 12 hours prior to study treatments and follow-up visits

Sites / Locations

  • The Center for Clinical and Cosmetic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Treatment

Sham Treatment

Arm Description

Subjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings.

Subjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules.

Outcomes

Primary Outcome Measures

Percentage of subjects with HDSS scores of 1 or 2
The HDSS scale is a qualitative measure of the severity of the condition based on how it affects subjects' daily activities. Subjects select the statement that best reflects their experience with underarm sweating on a 4 point scale, with 1 = sweating never noticeable and 4 = sweating is intolerable.

Secondary Outcome Measures

Reduction in spontaneous axillary sweat production
Assessed by a gravimetric method as measured by a 50% reduction or more compared to baseline.
Subject Satisfaction
Subject satisfaction will be measured using a Patient Satisfaction Questionnaire (PSQ.)

Full Information

First Posted
October 22, 2012
Last Updated
November 21, 2017
Sponsor
Ulthera, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT01713673
Brief Title
Feasibility Study: Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
Official Title
Feasibility Study: A Prospective, Parallel, Randomized, Sham-controlled, Blinded Pilot Trial of the Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™ treatment will have a greater reduction in axillary sweating compared to subjects receiving Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at 7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will be completed to compare the amount of axillary sweating compared to baseline.
Detailed Description
This study is a prospective, single-center, randomized, sham-controlled, blinded pilot clinical trial. Subjects will be randomly assigned to one of two treatment groups in a 2:1 randomization scheme, two (2) subjects assigned to receive Ultherapy™ treatment to every one subject assigned to receive Sham treatment. Gravimetric measurement of sweat production and starch iodine tests will be performed, and Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained, prior to treatment and at each follow-up visit. Patient satisfaction will also be assessed. Sham treated subjects will have the option of continuing to Stage II and receive active treatment after completion of their Stage I 90 day study visit. In a protocol amendment, the initial Stage I study cohort, excluding Sham treated subjects who opt to continue to Stage II, will be recruited to complete one long-term follow-up visit at 365 days following subjects' second study treatment. The same follow-up assessments will be completed to compare the amount of axillary sweating compared to baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
Hyperhidrosis, Axillary sweating, Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Subjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings.
Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
Subjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules.
Intervention Type
Drug
Intervention Name(s)
Ulthera System Treatment
Other Intervention Name(s)
Ultherapy™
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Intervention Type
Drug
Intervention Name(s)
Sham treatment
Intervention Description
Study treatment using the Ulthera System, but delivering no ultrasound energy.
Primary Outcome Measure Information:
Title
Percentage of subjects with HDSS scores of 1 or 2
Description
The HDSS scale is a qualitative measure of the severity of the condition based on how it affects subjects' daily activities. Subjects select the statement that best reflects their experience with underarm sweating on a 4 point scale, with 1 = sweating never noticeable and 4 = sweating is intolerable.
Time Frame
30 days post-treatment #2
Secondary Outcome Measure Information:
Title
Reduction in spontaneous axillary sweat production
Description
Assessed by a gravimetric method as measured by a 50% reduction or more compared to baseline.
Time Frame
Participants will be followed to 365 days post treatment #2
Title
Subject Satisfaction
Description
Subject satisfaction will be measured using a Patient Satisfaction Questionnaire (PSQ.)
Time Frame
Participants will be followed to 365 days post-treatment #2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female, ages 18-75 Subject is in good health Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity over a period of 5 minutes A HDSS score is 3 or 4. An attempt will be made to approximate an equal number of scores 3 and 4 Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period Absence of physical conditions unacceptable to the investigator Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating Exclusion Criteria: Dermal disorder including infection at anticipated treatment sites in either axilla Previous botulinum toxin treatment of the axilla in the past year Expected use of botulinum toxin for the treatment of any other disease during the study period Known allergy to starch powder or iodine Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery Unwillingness to wash off deodorants and abstain use 72 hours prior to treatments or assessments History of previous Ultherapy™ treatment to the axilla Subjects with a history of a bleeding disorder Use of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis Inability to withhold use of antiperspirants and deodorants, or any other topical treatments for hyperhidrosis within 72 hours prior to study treatments and assessments Unwillingness for complete shaving or removal of underarm hair within 12 hours prior to study treatments and follow-up visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Nestor, MD, PhD
Organizational Affiliation
The Center for Clinical and Cosmetic Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs