Recruiting

Morpheus8

Sponsor:

InMode MD Ltd.

Code:

NCT05860972

Conditions

Hyperhidrosis Primary Focal Axilla

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.

Study Details

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

Conditions

Hyperhidrosis Primary Focal Axilla

Study ID

NCT05860972

Start date

Mar 9, 2023

Status verified date

Jun, 2023

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active group

Active group that will receive 2 treatments with the InMode RF Pro System with the Morpheus8 Applicator (with the 24 pin tip)

sham comparator: Sham group

Sham group that will receive 2 sham treatments with the same InMode RF Pro System and Morpheus8 Applicator (with a sham 24 pin tip).

Interventions

Morpheus8 Applicator (with the 24 pin tip) in the treatment of primary axillary hyperhidrosis.

After subjects meet the eligibility criteria, they will be randomized with a 1:1 ratio to one of two treatment groups: Active or Sham. Subjects will receive two active or sham treatments, one month apart, with the InMode RF Pro System with the Morpheus8 Applicator and 24 pins tip and will return for three follow up visits: 4 weeks 12 weeks and 24 weeks post the second treatment

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Meital Matalon, MS

949 258-8870meital.matalon@inmodemd.com

Maria Shusterman, RN

9492396522maria.shusterman@inmodemd.com

Locations

Southeastern Dermatology

Recruiting

Knoxville, Tennessee, United States, 37922

Contacts

Prianca Patel

865-474-8800ppatel@drdoppelt.com

Dallas Plastic Surgery Institute

Recruiting

Dallas, Texas, United States, 75231

Contacts

:Rachelle Winkle, RN

214-821-9114rachelle.winkle@dpsi.org

Principal Investigator:

Rod Rohrich, MD

More Information

Sponsor

InMode MD Ltd.

Last update posted

Jan 12, 2024

Last verified

Jun, 2023

Keywords

  • hyperhidrosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by InMode MD Ltd. on 2024-01-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.