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

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