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

NCT05860972 | Recruiting FDA Device

• 1 other identifier: DO611232A
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 4

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

Keywords

hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• 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

  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

  4 weeks

Secondary Outcomes (3)

• Percent of subjects with a perspiration intensity of 0-2 on the Minor's starch-iodine test Intensity

  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 who achieved a 2-point or greater decline in the Hyperhidrosis Disease Severity Scale.

  4 weeks

Study Arms (2)

Active group

ACTIVE COMPARATOR

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

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

Sham group

SHAM COMPARATOR

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

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

Interventions

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

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

Active group; Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (4)

Skinfluence

New York, New York, 11746, United States

ACTIVE NOT RECRUITING

Southeastern Dermatology

Knoxville, Tennessee, 37922, United States

RECRUITING

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

RECRUITING

RAMBAM Medical Center

Haifa, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rodney J Rohrich, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meital Matalon, MS

CONTACT

949 258-8870; meital.matalon@inmodemd.com

Maria Shusterman, RN

CONTACT

9492396522; maria.shusterman@inmodemd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The treatments will be performed by an operator/technician who will not be blinded to the type of treatment that the subject is receiving. Objective assessment of clinical improvements such as starch-iodine tests will administered by blinded study personnel. The blinded evaluators will review photographs of the treatment areas that underwent the starch-iodine test and will be blinded as to which photos were taken at the baseline, 4-week follow-up, 12-week follow-up and 24-week follow-up visits. The HDSS, which is an objective assessment, will also be evaluated by a blinded study personnel. All subjects and study staff will be unblinded at the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 RF 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 RF 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.

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 16, 2023
• Study Start: March 9, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: January 12, 2024

Record last verified: 2023-06

Locations

US (3); IL (1)