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

Ulthera

Status: Completed

Conditions: Hyperhidrosis

Treatments: Device: Ulthera System treatment; Device: Sham treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01713959

ULT-121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

Group A - Split Body Treatment

Experimental group

Description:

Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.

Treatment:

Device: Ulthera System treatment

Device: Sham treatment

Group B: Ulthera System Treatment w lido

Active Comparator group

Description:

Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.

Treatment:

Device: Ulthera System treatment