Clinical trial NCT01713959: Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis
Official title: Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Keywords: Underarm sweating
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in sweat production
timeFrame: 90-days post-treatment treatment #2
Secondary outcomes:
measure: Improvement in sweat production at follow-up timepoints other than 90 days post-treatment
timeFrame: Participants will be followed up to 60 days post-treatment
measure: Area of efficacy
timeFrame: Participants will be followed for up to 90 days following treatment #2.
measure: Qualitative measure of hyperhidrosis severity
timeFrame: Participants will be followed for up to 90 days following treatment #2
Other outcomes:
Locations:
city: Aventura
country: United States
facility: The Center for Clinical & Cosmetic Research
state: Florida
Study officials:
affiliation: The Center for Clinical & Cosmetic Research
name: Mark Nestor, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: