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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01713959
First received: October 15, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Improvement in sweat production [ Time Frame: 90-days post-treatment treatment #2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be followed up to 60 days post-treatment ] [ Designated as safety issue: No ]
    Axillary hyperhidrosis as assessed by using a gravimetric method.

  • Area of efficacy [ Time Frame: Participants will be followed for up to 90 days following treatment #2. ] [ Designated as safety issue: No ]
    Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained.

  • Qualitative measure of hyperhidrosis severity [ Time Frame: Participants will be followed for up to 90 days following treatment #2 ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A - Split Body Treatment
Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.
Device: Ulthera System treatment
Ulthera System: Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ulthera® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening
Device: Sham treatment
Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.
Active Comparator: Group B: Ulthera System Treatment w lido
Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.
Device: Ulthera System treatment
Ulthera System: Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ulthera® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.
  • Ultrasound treatment for skin tightening

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01713959

Locations
United States, Florida
The Center for Clinical & Cosmetic Research
Aventura, Florida, United States, 33180
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Mark Nestor, MD, Ph.D The Center for Clinical & Cosmetic Research
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713959     History of Changes
Other Study ID Numbers: ULT-121
Study First Received: October 15, 2012
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Underarm sweating

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014