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

NCT01713673 | Completed

• 1 other identifier: ULT-125
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperhidrosis

Keywords

Hyperhidrosis; Axillary sweating; Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reduction in spontaneous axillary sweat production

  Participants will be followed to 365 days post treatment #2

• Subject Satisfaction

  Participants will be followed to 365 days post-treatment #2

Study Arms (2)

Active Treatment

EXPERIMENTAL

Subjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings.

Drug: Ulthera System Treatment

Sham Treatment

SHAM COMPARATOR

Subjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules.

Drug: Sham treatment

Interventions

Ulthera System Treatment DRUG

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Active Treatment

Sham treatment DRUG

Study treatment using the Ulthera System, but delivering no ultrasound energy.

Sham Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark Nestor, MD, PhD

  The Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 25, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2013
• Last Updated: November 24, 2017

Record last verified: 2013-06

Locations

US (1)