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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.
Subjects will be randomized to one of two study groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Split Body Treatment | Experimental | Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla. |
|
| Group B: Ulthera System Treatment w lido | Active Comparator | Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera System treatment | Device | Ulthera System: Focused ultrasound energy delivered below the surface of the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in sweat production | Axillary hyperhidrosis as assessed by using a gravimetric method. | 90-days post-treatment treatment #2 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Nestor, MD, Ph.D | The Center for Clinical & Cosmetic Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Clinical & Cosmetic Research | Aventura | Florida | 33180 | United States |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Sham treatment | Device | Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy. |
|
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 |