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

Not Applicable

Completed

• Conditions: Hyperhidrosis
• Interventions: Device: Ulthera System treatment; Device: Sham treatment

• Registration Number: NCT01713959
• Lead Sponsor: Ulthera, Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-04
• Study Completion: 2012-06
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Status Verified: 2013-06
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - Split Body Treatment	Ulthera System treatment	Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.
Group B: Ulthera System Treatment w lido	Ulthera System treatment	Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.
Group A - Split Body Treatment	Sham treatment	Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.

Primary Outcome Measures

Name	Time	Method
Improvement in sweat production	90-days post-treatment treatment #2	Axillary hyperhidrosis as assessed by using a gravimetric method.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Center for Clinical & Cosmetic Research; 🇺🇸 Aventura, Florida, United States