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

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