RECRUITING

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

Talk to us

Conditions

Hyperhidrosis Primary Focal Axillahyperhidrosis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-03-09
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05860972

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale (HDSS).
  2. * 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:
  3. * Bilateral and relatively symmetric
  4. * Impairs daily activities
  5. * Frequency of at least one episode per week
  6. * Age of onset less than 25 years old
  7. * Positive family history
  8. * Cessation of focal sweating during sleep
  9. * Subject is willing and able to comply with protocol requirements and all study visits
  10. * Willing to have de-identified images of the treated areas taken for possible use in publications and presentations.
  11. * Subject understands the study and has provided written informed consent
  1. * Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
  2. * Severe concurrent conditions such as cardiac disorders epilepsy, uncontrolled hypertension, and liver or kidney diseases.
  3. * Any active skin condition in the treatment area, such as sores, psoriasis, eczema and rash.
  4. * Swollen axillary lymph nodes.
  5. * History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
  6. * Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
  7. * History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
  8. * 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
  9. * Use of Isotretinoin (Accutane®) within 6 months prior to study
  10. * 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.
  11. * Currently participating in or recently participated in another clinical trial (within the last 30 days).
  12. * History of or current neurologic deficit in the treatment limb.
  13. * Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine).
  14. * Current or history of cancer, including skin cancer, or premalignant moles.
  15. * Injury in the treatment area or any other condition that, in the opinion of the investigator, might make treatment unsafe.
  16. * Subject has a pacemaker, defibrillator or other electronic implant anywhere in the body.
  17. * Permanent implant in the treated area such as metal plates, screws and metal piercing or silicon.
  18. * Females who are pregnant or nursing
  19. * Female subjects of childbearing potential not willing to use an acceptable form of contraception for the duration of the study.

Contacts and Locations

Study Contact

Meital Matalon, MS
CONTACT
949 258-8870
meital.matalon@inmodemd.com
Maria Shusterman, RN
CONTACT
9492396522
maria.shusterman@inmodemd.com

Principal Investigator

Rodney J Rohrich, MD
PRINCIPAL_INVESTIGATOR

Study Locations (Sites)

Skinfluence
New York, New York, 11746
United States
Southeastern Dermatology
Knoxville, Tennessee, 37922
United States
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: InMode MD Ltd.

  • Rodney J Rohrich, MD, PRINCIPAL_INVESTIGATOR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-09
Study Completion Date2026-04

Study Record Updates

Study Start Date2023-03-09
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • hyperhidrosis

Additional Relevant MeSH Terms

  • Hyperhidrosis Primary Focal Axilla