Clinical trial NCT01722461: A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis
Official title: A Prospective, Multi-Center, Parallel, Randomized, Double-Blinded Study of the Efficacy and Safety of the Ulthera® System for the Treatment of Primary Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Axillary Hyperhidrosis
Keywords: Excessive underarm sweating
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will be randomly assigned to receive either active treatments for axillary hyperhidrosis with the Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the energy settings on the device set to deliver no ultrasound energy. Subjects will be randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.

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.


Eligibility criteria: Inclusion Criteria:

* Male and female, age 18 years or older.
* 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 a dermal disorder including infection at anticipated treatment sites in either axilla.
* 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

Primary outcomes:
measure: Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
timeFrame: 30 days post-treatment #2
Secondary outcomes:
measure: Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
timeFrame: 6 month post treatment #2
measure: Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
timeFrame: 12 months post treatment #2
measure: Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production
timeFrame: 3 months post treatment
measure: Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production
timeFrame: Subjects will be followed to 12 months post treatment #2
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Roseville Facial Plastic Surgery
state: California
city: Aventura
country: United States
facility: The Center for Clinical and Cosmetic Research
state: Florida
city: Chicago
country: United States
facility: Few Institute of Aesthetic Plastic Surgery
state: Illinois
city: Saint Louis
country: United States
facility: St Louis University Dermatology
state: Missouri
city: New York
country: United States
facility: Day Dermatology & Aesthetics
state: New York
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
Study officials:
affiliation: The Center for Clinical and Cosmetic Research
name: Mark S Nestor, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: