Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosi… (NCT05860972) | Clinical Trial Compass
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Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency
United States, Israel70 participantsStarted 2023-03-09
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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
Exclusion Criteria:
Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
* 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 immu…
What they're measuring
1
A statistically significant difference in the percent of responders defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2 at the 4-week