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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01713673
First received: October 22, 2012
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Hyperhidrosis
Drug: Ulthera System Treatment
Drug: Sham treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Percentage of subjects with HDSS scores of 1 or 2 [ Time Frame: 30 days post-treatment #2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be followed to 365 days post treatment #2 ] [ Designated as safety issue: No ]
    Assessed by a gravimetric method as measured by a 50% reduction or more compared to baseline.

  • Subject Satisfaction [ Time Frame: Participants will be followed to 365 days post-treatment #2 ] [ Designated as safety issue: No ]
    Subject satisfaction will be measured using a Patient Satisfaction Questionnaire (PSQ.)


Enrollment: 20
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment
Subjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings.
Drug: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
Sham Comparator: Sham Treatment
Subjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules.
Drug: Sham treatment
Study treatment using the Ulthera System, but delivering no ultrasound energy.

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.

  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 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
  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: NCT01713673

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

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01713673     History of Changes
Other Study ID Numbers: ULT-125
Study First Received: October 22, 2012
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Hyperhidrosis
Axillary sweating
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014