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Feasibility Study: Ulthera® System for the 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 Underarm sweating

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 (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
  • HDSS score of 3 or 4.
  • Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

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.
  • Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.

Sites / Locations

  • The Center for Clinical & Cosmetic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A - Split Body Treatment

Group B: Ulthera System Treatment w lido

Arm Description

Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.

Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.

Outcomes

Primary Outcome Measures

Improvement in sweat production
Axillary hyperhidrosis as assessed by using a gravimetric method.

Secondary Outcome Measures

Improvement in sweat production at follow-up timepoints other than 90 days post-treatment
Axillary hyperhidrosis as assessed by using a gravimetric method.
Area of efficacy
Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained.
Qualitative measure of hyperhidrosis severity
The HDSS is a scale used for primary axillary/underarm hyperhidrosis patients. It provides a qualitative measure of the severity of their condition based on how it affects their daily activities. Patients select the statement that best reflects their experience with underarm sweating.

Full Information

First Posted
October 15, 2012
Last Updated
November 21, 2017
Sponsor
Ulthera, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01713959
Brief Title
Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis
Official Title
Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
June 2012 (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
Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at 7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2.
Detailed Description
Subjects will be randomized to one of two study groups: Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other axilla. Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine injection administered to one axillary side. Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be obtained at all study visits. Patient satisfaction questionnaires will also be obtained at 30, 60 and 90 days post-treatment #2.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - Split Body Treatment
Arm Type
Experimental
Arm Description
Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.
Arm Title
Group B: Ulthera System Treatment w lido
Arm Type
Active Comparator
Arm Description
Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.
Intervention Type
Device
Intervention Name(s)
Ulthera System treatment
Other Intervention Name(s)
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Intervention Description
Ulthera System: Focused ultrasound energy delivered below the surface of the skin.
Intervention Type
Device
Intervention Name(s)
Sham treatment
Intervention Description
Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.
Primary Outcome Measure Information:
Title
Improvement in sweat production
Description
Axillary hyperhidrosis as assessed by using a gravimetric method.
Time Frame
90-days post-treatment treatment #2
Secondary Outcome Measure Information:
Title
Improvement in sweat production at follow-up timepoints other than 90 days post-treatment
Description
Axillary hyperhidrosis as assessed by using a gravimetric method.
Time Frame
Participants will be followed up to 60 days post-treatment
Title
Area of efficacy
Description
Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained.
Time Frame
Participants will be followed for up to 90 days following treatment #2.
Title
Qualitative measure of hyperhidrosis severity
Description
The HDSS is a scale used for primary axillary/underarm hyperhidrosis patients. It provides a qualitative measure of the severity of their condition based on how it affects their daily activities. Patients select the statement that best reflects their experience with underarm sweating.
Time Frame
Participants will be followed for up to 90 days following 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 (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.) HDSS score of 3 or 4. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. 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. Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Nestor, MD, Ph.D
Organizational Affiliation
The Center for Clinical & Cosmetic Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Clinical & Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

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

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