Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency

Eligibility Criteria

• * Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS).
• * Subject has primary focal axillary hyperhidrosis evidenced by at least 6 months of visible, detectable, focal, exaggerated sweating without any apparent explanation and at least two of the following:
• * Bilateral and relatively symmetric
• * Impairs daily activities
• * Frequency of at least one episode per week
• * Age of onset less than 25 years old
• * Positive family history
• * Cessation of focal sweating during sleep
• * Subject is willing and able to comply with protocol requirements and all study visits
• * Willing to have de-identified images of the treated areas taken for possible use in publications and presentations.
• * Subject understands the study and has provided written informed consent
• * Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
• * Severe concurrent conditions such as cardiac disorders epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• * Any active skin condition in the treatment area, such as sores, psoriasis, eczema and rash.
• * Swollen axillary lymph nodes.
• * History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• * Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• * History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
• * Prior endoscopic thoracic sympathectomy, liposuction or other surgery for hyperhidrosis in the treated area. Injection of botulinum toxin in the treated area within one year
• * Use of Isotretinoin (Accutane®) within 6 months prior to study
• * Oral anticholinergic medication use (e.g., Robinul) or cholinomimetic medication use within the last 4 weeks or planned use during the study's follow up phase.
• * Currently participating in or recently participated in another clinical trial (within the last 30 days).
• * History of or current neurologic deficit in the treatment limb.
• * Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine).
• * Current or history of cancer, including skin cancer, or premalignant moles.
• * Injury in the treatment area or any other condition that, in the opinion of the investigator, might make treatment unsafe.
• * Subject has a pacemaker, defibrillator or other electronic implant anywhere in the body.
• * Permanent implant in the treated area such as metal plates, screws and metal piercing or silicon.
• * Females who are pregnant or nursing
• * Female subjects of childbearing potential not willing to use an acceptable form of contraception for the duration of the study.