A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis

Primary Axillary Hyperhidrosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01722461
• Other study ID #: ULT-119
• Status: Terminated
• Phase: N/A
• First received: November 2, 2012
• Last updated: November 21, 2017
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperhidrosis
• Primary Axillary Hyperhidrosis

Intervention

Device:
• Ulthera System
Focused ultrasound energy delivered below the surface of the skin
• Sham treatment
Ulthera System delivering no ultrasound energy

Locations

Country	Name	City	State
United States	The Center for Clinical and Cosmetic Research	Aventura	Florida
United States	Few Institute of Aesthetic Plastic Surgery	Chicago	Illinois
United States	Day Dermatology & Aesthetics	New York	New York
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Roseville Facial Plastic Surgery	Roseville	California
United States	St Louis University Dermatology	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating	As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire	30 days post-treatment #2
Secondary	Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating	As measured by the HDSS	6 month post treatment #2
Secondary	Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating	As measured by the HDSS	12 months post treatment #2
Secondary	Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production	As measured by gravimetric method	3 months post treatment
Secondary	Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production	As measured by gravimetric method	Subjects will be followed to 12 months post treatment #2