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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hyperhidrosis

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - Split Body Treatment<br>Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla. | Device: Ulthera System treatment<br>* Ulthera System: Focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ultrasound treatment for skin tightening;Device: Sham treatment<br>* Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.<br>|
| Active Comparator: Group B: Ulthera System Treatment w lido<br>Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection. | Device: Ulthera System treatment<br>* Ulthera System: Focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ultrasound treatment for skin tightening;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sweat production | Axillary hyperhidrosis as assessed by using a gravimetric method. | 90-days post-treatment treatment #2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sweat production at follow-up timepoints other than 90 days post-treatment | Axillary hyperhidrosis as assessed by using a gravimetric method. | Participants will be followed up to 60 days post-treatment | 
| Area of efficacy | Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained. | Participants will be followed for up to 90 days following treatment #2. | 
| Qualitative measure of hyperhidrosis severity | 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. | Participants will be followed for up to 90 days following treatment #2 | 

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