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

Feasibility Study: A Prospective, Parallel, Randomized, Sham-controlled, Blinded Pilot Trial of the Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis

Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™ treatment will have a greater reduction in axillary sweating compared to subjects receiving Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at 7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will be completed to compare the amount of axillary sweating compared to baseline.

Study Overview

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

Detailed Description

This study is a prospective, single-center, randomized, sham-controlled, blinded pilot clinical trial. Subjects will be randomly assigned to one of two treatment groups in a 2:1 randomization scheme, two (2) subjects assigned to receive Ultherapy™ treatment to every one subject assigned to receive Sham treatment.

Gravimetric measurement of sweat production and starch iodine tests will be performed, and Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained, prior to treatment and at each follow-up visit. Patient satisfaction will also be assessed. Sham treated subjects will have the option of continuing to Stage II and receive active treatment after completion of their Stage I 90 day study visit.

In a protocol amendment, the initial Stage I study cohort, excluding Sham treated subjects who opt to continue to Stage II, will be recruited to complete one long-term follow-up visit at 365 days following subjects' second study treatment. The same follow-up assessments will be completed to compare the amount of axillary sweating compared to baseline.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 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 over a period of 5 minutes
• A HDSS score is 3 or 4. An attempt will be made to approximate an equal number of scores 3 and 4
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period
• Absence of physical conditions unacceptable to the investigator
• Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating

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
• Unwillingness to wash off deodorants and abstain use 72 hours prior to treatments or assessments
• History of previous Ultherapy™ treatment to the axilla
• Subjects with a history of a bleeding disorder
• Use of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis
• Inability to withhold use of antiperspirants and deodorants, or any other topical treatments for hyperhidrosis within 72 hours prior to study treatments and assessments
• Unwillingness for complete shaving or removal of underarm hair within 12 hours prior to study treatments and follow-up visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment; Subjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings.	Drug: Ulthera System Treatment; Focused ultrasound energy delivered below the surface of the skin; Other Names: Ultherapy™
Sham Comparator: Sham Treatment; Subjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules.	Drug: Sham treatment; Study treatment using the Ulthera System, but delivering no ultrasound energy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with HDSS scores of 1 or 2	The HDSS scale is a qualitative measure of the severity of the condition based on how it affects subjects' daily activities. Subjects select the statement that best reflects their experience with underarm sweating on a 4 point scale, with 1 = sweating never noticeable and 4 = sweating is intolerable.	30 days post-treatment #2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in spontaneous axillary sweat production	Assessed by a gravimetric method as measured by a 50% reduction or more compared to baseline.	Participants will be followed to 365 days post treatment #2
Subject Satisfaction	Subject satisfaction will be measured using a Patient Satisfaction Questionnaire (PSQ.)	Participants will be followed to 365 days post-treatment #2

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Mark Nestor, MD, PhD, The Center for Clinical and Cosmetic Research

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 22, 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: Hyperhidrosis; Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Axillary sweating
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: ULT-125