A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
NCT ID: NCT01722461
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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TERMINATED
NA
120 participants
INTERVENTIONAL
2012-11-30
2013-11-30
Brief Summary
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Subjects and study personnel conducting efficacy measures will be blinded to the assigned treatment groups. The study hypothesis is that subjects in the active treatment group will have a greater reduction in underarm sweating compared to those in the sham group as measured by a quality of life questionnaire.
All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their second study treatment. Subjects in the active treatment group will also undergo follow-up assessments at 9 months and 12 months from the date of their second study treatment.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active treatment
Ulthera System treatment
Ulthera System
Focused ultrasound energy delivered below the surface of the skin
Sham treatment
Ulthera System delivering no ultrasound energy
Sham treatment
Ulthera System delivering no ultrasound energy
Interventions
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Ulthera System
Focused ultrasound energy delivered below the surface of the skin
Sham treatment
Ulthera System 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 primary focal axillary hyperhidrosis evidenced by at least two of the standard criteria.
* At least 50mg at 5 min of spontaneous resting axillary sweat production in each axilla measured gravimetrically
* A HDSS score of 3 or 4
* Willingness to comply with study visits and requirements
* Female subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1
* Female subjects over 40 years of age must have had a mammogram in the last 2 years
Exclusion Criteria
* Has had axillary injections of botulinum toxin in the last year.
* Has an expected use of botulinum toxin for the treatment of any other disease during the study period.
* Has a known allergy to starch powder, iodine, or lidocaine.
* Has secondary hyperhidrosis
* Has had previous surgical treatment of hyperhidrosis
* Has had prior miraDry treatment for axillary hyperhidrosis.
* Has used prescription antiperspirants in the last 14 days or plans to use them during the study period.
* Inability to withhold use of non-study-supplied antiperspirants and deodorants
* Unwillingness to wash off study-supplied antiperspirants and abstain from use for 72 hours prior to treatments or assessments.
* History of previous Ultherapy™ treatment to the axilla.
* Has a history of a bleeding disorder
* Has used of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for hyperhidrosis in the past 4 weeks.
* Is a prisoner or under incarceration.
* Is participating in another clinical trial involving the use of investigational devices or drugs (or has in the last 30 days.)
* Has a history of cancer (some exceptions), lymphectomy, or a planned lymphectomy.
* Has a pacemaker or other electronic implant.
* Requires supplemental oxygen.
* Has used antiplatelet agents / Anticoagulants (Coumadin, Pradaxa, Heparin, Plavix) in the past 6 weeks
18 Years
ALL
No
Sponsors
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Ulthera, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Mark S Nestor, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Center for Clinical and Cosmetic Research
Locations
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Roseville Facial Plastic Surgery
Roseville, California, United States
The Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Few Institute of Aesthetic Plastic Surgery
Chicago, Illinois, United States
St Louis University Dermatology
St Louis, Missouri, United States
Day Dermatology & Aesthetics
New York, New York, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Countries
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Other Identifiers
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ULT-119
Identifier Type: -
Identifier Source: org_study_id