Back to resultsHistological Analysis Following Ulthera System Treatment for Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera System Treatment
Sponsored by
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
Inclusion Criteria:
- Male and female, ages 18-75
- Subject is in good health
- Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
- Groups A, C, D and E: 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.
Sites / Locations
- The Center for Clinical and Cosmetic Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Group D
Group E
Arm Description
Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.
Subjects who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.
Subjects will receive one double-density Ulthera System treatment; dual depth treatment at 4.5mm and 3.0mm.
Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and standard energy level.
Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and adjusted energy level.
Outcomes
Primary Outcome Measures
Reduction in the number of sweat glands from baseline to 90-days post-treatment.
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
A 50% reduction or more in Gravimetric measure at 7 days post-treatment compared to baseline.
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
A 50% reduction or more in Gravimetric measure at 30 days post-treatment compared to baseline.
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
A 50% reduction or more in Gravimetric measure at 90 days post-treatment compared to baseline.
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
A 50% reduction or more in Gravimetric measure at 180 days post-treatment compared to baseline.
HDSS score reduction
HDSS score reduction from a 3 or 4 to a 1 or 2
Starch iodine test
Assess the reduction in starch iodine test area at 90 days post-treatment compared to baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708551
Brief Title
Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
Official Title
Histological Analysis and Correlation With Ultrasound Imaging to Evaluate the Safety and Effectiveness of Treating Axillary Hyperhidrosis Subjects With the Ulthera® System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (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 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in Groups A, B or C will undergo axillary punch biopsies during the course of the trial to determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days post-treatment #2.
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); dual-depth treatment at 4.5mm and 3.0mm;
those who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis (Group B, n=approx 5), dual-depth treatment at 4.5mm and 3.0mm;
those naïve to Ultherapy™ for treatment of hyperhidrosis who will receive one double-density study treatment (Group C, n=4), dual-depth treatment at 4.5mm and 3.0mm;
those naïve to Ultherapy™ for treatment of hyperhidrosis (Group D, n=10), single-depth treatment at 2.0mm at standard energy;
those naïve to Ultherapy™ for treatment of hyperhidrosis (Group E, n=10), single-depth treatment at 2.0mm at adjusted energy.
Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40 lines per treatment square.
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.
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subjects who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Subjects will receive one double-density Ulthera System treatment; dual depth treatment at 4.5mm and 3.0mm.
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and standard energy level.
Arm Title
Group E
Arm Type
Active Comparator
Arm Description
Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and adjusted energy level.
Intervention Type
Device
Intervention Name(s)
Ulthera System Treatment
Other Intervention Name(s)
Ultherapy™
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Primary Outcome Measure Information:
Title
Reduction in the number of sweat glands from baseline to 90-days post-treatment.
Description
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.
Time Frame
90 days post-treatment
Secondary Outcome Measure Information:
Title
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Description
A 50% reduction or more in Gravimetric measure at 7 days post-treatment compared to baseline.
Time Frame
7 days post-treatment
Title
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Description
A 50% reduction or more in Gravimetric measure at 30 days post-treatment compared to baseline.
Time Frame
30 days post-treatment
Title
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Description
A 50% reduction or more in Gravimetric measure at 90 days post-treatment compared to baseline.
Time Frame
90 days post-treatment
Title
Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
Description
A 50% reduction or more in Gravimetric measure at 180 days post-treatment compared to baseline.
Time Frame
180 days post-treatment
Title
HDSS score reduction
Description
HDSS score reduction from a 3 or 4 to a 1 or 2
Time Frame
90 days post-treatment
Title
Starch iodine test
Description
Assess the reduction in starch iodine test area at 90 days post-treatment compared to baseline.
Time Frame
90 days post-treatment
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
Groups A, C, D and E: 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.
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
Histological Analysis Following Ulthera System Treatment for Hyperhidrosis
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