Feasibility Study: Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
NCT ID: NCT01713673
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2011-12-31
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Active Treatment
Subjects receive Ulthera System Treatments according to the pre-defined Ulthera® System energy settings.
Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Sham Treatment
Subjects will receive Sham treatments using the Ulthera® System with the energy set to 0.00 Joules.
Sham treatment
Study treatment using the Ulthera System, but delivering no ultrasound energy.
Interventions
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Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Sham treatment
Study treatment using the Ulthera System, but delivering no ultrasound energy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ulthera, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Nestor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Center for Clinical and Cosmetic Research
Locations
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The Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Countries
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Other Identifiers
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ULT-125
Identifier Type: -
Identifier Source: org_study_id