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

Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Device: Ulthera System treatment; Device: Sham treatment

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Aventura, Florida, United States, 33180
      • The Center for Clinical & Cosmetic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - Split Body Treatment; Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.	Device: Ulthera System treatment; Ulthera System: Focused ultrasound energy delivered below the surface of the skin.; Other Names: Ulthera, Inc.; Ultrasound treatment for skin tightening; Ulthera® System; Ultherapy™ Treatment; Device: Sham treatment; Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.
Active Comparator: Group B: Ulthera System Treatment w lido; Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.	Device: Ulthera System treatment; Ulthera System: Focused ultrasound energy delivered below the surface of the skin.; Other Names: Ulthera, Inc.; Ultrasound treatment for skin tightening; Ulthera® System; Ultherapy™ Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in sweat production	Axillary hyperhidrosis as assessed by using a gravimetric method.	90-days post-treatment treatment #2

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Mark Nestor, MD, Ph.D, The Center for Clinical & Cosmetic Research

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Underarm sweating
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: ULT-121