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

Completed · Not applicable · Has a placebo group

Conditions studied: Hyperhidrosis

In brief

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.

Key facts

Study ID

NCT01713673

Run by

Ulthera, Inc

People needed

20

Starts

2011-12-01

Expected to finish

2013-04-01

Last updated by the study team

2017-11-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• The Center for Clinical and Cosmetic Research — Aventura, Florida, United States

Full record on ClinicalTrials.gov

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