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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperhidrosis Primary Focal Axilla
- Sponsor
- InMode MD Ltd.
- Enrollment
- 70
- Locations
- 4
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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
Detailed Description
Study subjects will be consecutively screened and enrolled into the study. The study will consist of an active group that will receive 2 treatments with the InMode radio frequency Pro System with the Morpheus8 Applicator (with the 24 pin tip) and a sham group that will receive 2 sham treatments with the same InMode radio frequency Pro System and Morpheus8 Applicator (with a sham 24 pin tip). Treatment will be performed in a preheated controlled environment (T°≥22°C). Follow up visits will occur at 1 month, 3 months, and 6 months post treatment
Investigators
Eligibility Criteria
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
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 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
Outcomes
Primary Outcomes
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
Time Frame: 4 weeks
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 follow-up visit, in the treatment group compared to the sham group
Secondary Outcomes
- Percent of subjects who achieved a 2-point or greater decline in the Hyperhidrosis Disease Severity Scale.(4 weeks)
- Percent of responders, defined as subjects reporting a Hyperhidrosis Disease Severity Scale (HDSS) score of 1 or 2(12 weeks)
- Percent of subjects with a perspiration intensity of 0-2 on the Minor's starch-iodine test Intensity(4 weeks)