Clinical Evaluation of the Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator (With the 24 Pin Tip) for the Treatment of Primary Focal Hyperhidrosis of the Axillae Using Fractional RF Technology
The InMode radio frequency Pro System with the Morpheus8 Applicator is a computerized system generating radio frequency energy, based on the underlying technology of Fractional RF. The Morpheus8 Applicator and 24 pin tip is used for the treatment of primary hyperhidrosis of the axillae
⁃ Subject is 18 years of age or older at the time of consent.
• 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