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

Launched by INMODE MD LTD. · May 5, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for excessive sweating in the armpits, a condition known as primary focal axillary hyperhidrosis. The trial is using a special device called the Morpheus8 Applicator, which uses radio frequency energy to target and help reduce sweating. Researchers want to see if this treatment is both safe and effective for those who suffer from this condition. The study is currently recruiting participants who are at least 18 years old and have been experiencing noticeable sweating in their armpits for at least six months.

To be eligible for the trial, participants should have a specific level of sweating that affects their daily life, such as sweating at least once a week. However, there are certain health conditions and medications that would exclude someone from participating, so it’s important to review those carefully. If you join the trial, you can expect to attend a few study visits where your treatment will be administered, and your progress will be monitored. Additionally, you may need to allow the researchers to take pictures of the treated areas for further study. Overall, this trial offers a potential new option for those struggling with excessive sweating and aims to improve their quality of life.

Gender

ALL

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
• • 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 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.