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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ulthera, Inc

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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