A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis

Study Overview
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Brief Summary
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This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to deliver no ultrasound energy. Subjects will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart. Subjects and study personnel conducting efficacy measures will be blinded to the assigned treatment groups. The study hypothesis is that subjects in the active treatment group will have a greater reduction in underarm sweating compared to those in the sham group as measured by a quality of life questionnaire. All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their second study treatment. Subjects in the active treatment group will also undergo follow-up assessments at 9 months and 12 months from the date of their second study treatment.

Official Title
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A Prospective, Multi-Center, Parallel, Randomized, Double-Blinded Study of the Efficacy and Safety of the Ulthera® System for the Treatment of Primary Axillary Hyperhidrosis

Conditions
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Primary Axillary Hyperhidrosis

Intervention / Treatment
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* Device: Ulthera System
* Device: Sham treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female, age 18 years or older. Subject is in good health. Diagnosis of primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria. At least 50mg at 5 min of spontaneous resting axillary sweat production in each axilla measured gravimetrically A HDSS score of 3 or 4 Willingness to comply with study visits and requirements Female subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 Female subjects over 40 years of age must have had a mammogram in the last 2 years Exclusion Criteria: Has a dermal disorder including infection at anticipated treatment sites in either axilla. Has had axillary injections of botulinum toxin in the last year. Has an expected use of botulinum toxin for the treatment of any other disease during the study period. Has a known allergy to starch powder, iodine, or lidocaine. Has secondary hyperhidrosis Has had previous surgical treatment of hyperhidrosis Has had prior miraDry treatment for axillary hyperhidrosis. Has used prescription antiperspirants in the last 14 days or plans to use them during the study period. Inability to withhold use of non-study-supplied antiperspirants and deodorants Unwillingness to wash off study-supplied antiperspirants and abstain from use for 72 hours prior to treatments or assessments. History of previous Ultherapy™ treatment to the axilla. Has a history of a bleeding disorder Has used of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis in the past 4 weeks. Is a prisoner or under incarceration. Is participating in another clinical trial involving the use of investigational devices or drugs (or has in the last 30 days.) Has a history of cancer (some exceptions), lymphectomy, or a planned lymphectomy. Has a pacemaker or other electronic implant. Requires supplemental oxygen. Has used antiplatelet agents / Anticoagulants (Coumadin, Pradaxa, Heparin, Plavix) in the past 6 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>Ulthera System treatment | Device: Ulthera System<br>* Focused ultrasound energy delivered below the surface of the skin<br>* Other names: Ultherapy™;|
| Sham Comparator: Sham treatment<br>Ulthera System delivering no ultrasound energy | Device: Sham treatment<br>* Ulthera System delivering no ultrasound energy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating | As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire | 30 days post-treatment #2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating | As measured by the HDSS | 6 month post treatment #2 | 
| Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating | As measured by the HDSS | 12 months post treatment #2 | 
| Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production | As measured by gravimetric method | 3 months post treatment | 
| Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production | As measured by gravimetric method | Subjects will be followed to 12 months post treatment #2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excessive underarm sweating