Histological Analysis Following Ulthera System Treatment for Hyperhidrosis - Full Text View

Purpose

Up to 40 subjects will be enrolled into one of three treatment groups. Enrolled subjects will undergo 4 axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive one bilateral Ultherapy™ treatment(Group C) or two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A and B). Follow-up visits will occur at 7, 30 and 90 days post-treatment #2.

Condition	Intervention
Hyperhidrosis	Device: Ulthera System Treatment

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Histological Analysis and Correlation With Ultrasound Imaging to Evaluate the Safety and Effectiveness of Treating Axillary Hyperhidrosis Subjects With the Ulthera® System

Resource links provided by NLM:

MedlinePlus related topics: Sweat

U.S. FDA Resources

Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:

Reduction in the number of sweat glands from baseline to 90-days post-treatment. [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
Based on histological analyses of biopsied, Ultherapy™-treated, tissue, the changed in the number of sweat glands present at 90days post-treatment will be compared to the number of sweat glands present at baseline.

Secondary Outcome Measures:

Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
A 50% reduction or more in Gravimetric measure at 90 days post-treatment compared to baseline.
HDSS score reduction [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
HDSS score reduction from a 3 or 4 to a 1 or 2
Starch iodine test [ Time Frame: 90 days post-treatment ] [ Designated as safety issue: No ]
Assess the reduction in starch iodine test area at 90 days post-treatment compared to baseline.

Estimated Enrollment:	40
Study Start Date:	August 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group A Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments.	Device: Ulthera System Treatment Focused ultrasound energy delivered below the surface of the skin Other Name: Ultherapy™
Active Comparator: Group B Subjects who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis will receive bilateral Ulthera System treatments.	Device: Ulthera System Treatment Focused ultrasound energy delivered below the surface of the skin Other Name: Ultherapy™
Active Comparator: Group C Subjects will receive one double-density Ulthera System treatment.	Device: Ulthera System Treatment Focused ultrasound energy delivered below the surface of the skin Other Name: Ultherapy™

Detailed Description:

This study is a prospective, single-center, non-randomized pilot clinical trial. Subjects enrolled will include those naïve to Ultherapy™ for treatment of hyperhidrosis (Group A, n=31), those who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis (Group B, n=approx 5), and those naive to Ultherapy who will receive one double-density study treatment (Group C, n=4). Ultrasound images will be captured of each axilla to assess dermal thickness and depth of sweat glands. A gravimetric measurement of sweat production and starch iodine test will be performed prior to treatment. Digital images of the starch iodine test will be obtained. Hyperhidrosis Disease Severity Scale (HDSS)scores will be obtained prior to each treatment. During treatment, the average Numeric Rating Scale (NRS) score will be obtained by axilla treated. Efficacy will be determined by a reduction in the number of sweat glands from baseline to 90-days post-treatment, as evidenced by histological analysis. Subject Gravimetric results, Starch iodine results, and HDSS scores at all follow-ups compared to baseline will also be analyzed as secondary outcomes.

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
Group A: 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.) Group B: A mean of >50mg/5min of sweat production following a prior Ultherapy treatment
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 at Visit 1 and be willing and able to use an acceptable method of birth control.

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, iodine, lidocaine, or epinephrine.
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.
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.
Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
Inability to understand the protocol or to give informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708551

Locations

United States, Florida
The Center for Clinical and Cosmetic Research	Recruiting
Aventura, Florida, United States, 33180
Contact: Julie Santos 305-933-6716 j.santos@ADMCORP.com
Principal Investigator: Mark Nestor, MD, PhD

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:	NCT01708551 History of Changes
Other Study ID Numbers:	ULT-134
Study First Received:	October 15, 2012
Last Updated:	January 18, 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 May 21, 2013