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

Ulthera, Inc15 enrolled

Overview

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: * 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperhidrosis

Interventions

Ulthera System treatmentDEVICE

Ulthera System: Focused ultrasound energy delivered below the surface of the skin.

Sham treatmentDEVICE

Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Center for Clinical & Cosmetic Research

Aventura, Florida, United States

Outcomes

Primary Outcomes

Improvement in sweat production

Axillary hyperhidrosis as assessed by using a gravimetric method.

Time frame: 90-days post-treatment treatment #2

Secondary Outcomes

Improvement in sweat production at follow-up timepoints other than 90 days post-treatment

Axillary hyperhidrosis as assessed by using a gravimetric method.

Time frame: 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.

Time frame: 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.

Time frame: Participants will be followed for up to 90 days following treatment #2

Data from ClinicalTrials.gov

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