Treatment of excessive sweating in the armpits using radio frequency technology
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
NA · InMode MD Ltd. · NCT05860972
This study is testing a new radio frequency treatment to see if it can help people with excessive sweating in their armpits feel more comfortable.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | InMode MD Ltd. (industry) |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Trial ID | NCT05860972 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of the Morpheus8 Applicator, a radio frequency device, for treating primary focal hyperhidrosis of the axillae. Participants will be divided into an active group receiving two treatments with the device and a sham group receiving placebo treatments. The procedure will take place in a controlled environment, and follow-up visits will occur at one, three, and six months post-treatment to assess outcomes. The study aims to determine if this innovative approach can effectively reduce excessive sweating in the underarm area.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with primary focal axillary hyperhidrosis and a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale.
Not a fit: Patients with secondary hyperhidrosis caused by medications, infections, malignancy, or endocrine disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from excessive underarm sweating.
How similar studies have performed: While the use of radio frequency technology for hyperhidrosis is a novel approach, similar studies have shown promise in treating other dermatological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 3 other locations
- Skinfluence — New York, New York, United States (ACTIVE_NOT_RECRUITING)
- Southeastern Dermatology — Knoxville, Tennessee, United States (RECRUITING)
- Dallas Plastic Surgery Institute — Dallas, Texas, United States (RECRUITING)
- RAMBAM Medical Center — Haifa, Israel (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Rodney J Rohrich, MD
- Study coordinator: Meital Matalon, MS
- Email: meital.matalon@inmodemd.com
- Phone: 949 258-8870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyperhidrosis Primary Focal Axilla, hyperhidrosis