Ulthera® System for Treating Axillary Hyperhidrosis

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, iodine, lidocaine, or epinephrine.
• •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.
• •Subjects with a history of a bleeding disorder
• •Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas.)
• •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.
• •Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
• •Inability to understand the protocol or to give informed consent.
• •History of chronic drug or alcohol abuse.
• •History of autoimmune disease.
• •Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• •Subjects who anticipate the need for surgery or overnight hospitalization during the study.
• •Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
• •Concurrent enrollment in any study involving the use of investigational devices or drugs.
• •Use of antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix) in the past 6 weeks;
• •Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements.